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MEDICAL products beginning with : O
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 PRODUCT NAMEFDA Code/Regulation 
Obstetric Anesthesia Set (2 suppliers)

Identification. An obstetric anesthesia set is an assembly of antiseptic solution, needles, needle guides, syringes, and other accessories, intended for use with an anesthetic drug. This device is used to administer regional blocks (e.g., paracervical, uterosacral, and pudendal) that may be used during labor, delivery, or both.

Classification. Class II (performance standards).

KNE / 884.5100
Obstetric Data Analyzer (1 supplier)

Identification. An obstetric data analyzer (fetal status data analyzer) is a device used during labor to analyze electronic signal data obtained from fetal and maternal monitors. The obstetric data analyzer provides clinical diagnosis of fetal status and recommendations for labor management and clinical interventions. This generic type of device may include signal analysis and display equipment, electronic interfaces for other equipment, and power supplies and component parts.

Classification. Class III (premarket approval).

HEO / 884.2050
Obstetric Fetal Destructive Instrument (1 supplier)

Identification. An obstetric fetal destructive instrument is a device designed to crush or pull the fetal body to facilitate the delivery of a dead or anomalous (abnormal) fetus. This generic type of device includes the cleidoclast, cranioclast, craniotribe, and destructive hook.

Classification. Class II (performance standards).

KNB / 884.4500
Obstetric pH Paper (7 suppliers)

Identification. A urinary pH (nonquantitative) test system is a device intended to estimate the pH of urine. Estimations of pH are used to evaluate the acidity or alkalinity of urine as it relates to numerous renal and metabolic disorders and in the monitoring of patients with certain diets.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 862.9.

LNW / 862.1550
Obstetric Ultrasonic Transducer (10 suppliers)

Identification. An obstetric ultrasonic transducer is a device used to apply ultrasonic energy to, and to receive ultrasonic energy from, the body in conjunction with an obstetric monitor or imager. The device converts electrical signals into ultrasonic energy, and vice versa, by means of an assembly distinct from an ultrasonic generator. This generic type of device may include the following accessories: coupling gel, preamplifiers, amplifiers, signal conditioners with their power supply, connecting cables, and component parts. This generic type of device does not include devices used to generate the ultrasonic frequency electrical signals for application.

Classification. Class II (performance standards).

HGL / 884.2960
Obstetrical Destructive Hook (4 suppliers)

Identification. An obstetric fetal destructive instrument is a device designed to crush or pull the fetal body to facilitate the delivery of a dead or anomalous (abnormal) fetus. This generic type of device includes the cleidoclast, cranioclast, craniotribe, and destructive hook.

Classification. Class II (performance standards).

HDI / 884.4500
Obstetrical Forceps (110 suppliers)
The obstetric forceps is designed to grasp the fetal head when it is in the vagina and bring about delivery by traction and guidance without causing injury to the mother or baby. It consists of two arms, which are movable. The obstetric forceps consists of blade that has two curves. The cephalic curve is adapted to provide a good application to the fetal head. The pelvic curve allows the blades to fit in with the curve of the birth canal.

Identification. An obstetric forceps is a device consisting of two blades, with handles, designed to grasp and apply traction to the fetal head in the birth passage and facilitate delivery.

Classification. Class II (performance standards).

HDA / 884.4400
Obstetrical Kits (6 suppliers)

Identification. An obstetric-gynecologic general manual instrument is one of a group of devices used to perform simple obstetric and gynecologic manipulative functions. This generic type of device consists of the following:

Classification. Class I (general controls). The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 884.9.

OKV / 884.4520
Obstetrical Table and Accessories (10 suppliers)

Identification. An obstetric table is a device with adjustable sections designed to support a patient in the various positions required during obstetric and gynecologic procedures. This generic type of device may include the following accessories: patient equipment, support attachments, and cabinets for warming instruments and disposing of wastes.

Classification. Class II (performance standards).

KNC / 884.4900
Occluding Ballon Neuro-Vasculature Catheter (1 supplier)

Identification. An intravascular occluding catheter is a catheter with an inflatable or detachable balloon tip that is used to block a blood vessel to treat malformations, e.g., aneurysms (balloonlike sacs formed on blood vessels) of intracranial blood vessels.

Classification. Class III (premarket approval).

NUF / 882.5150
Occlusive Wound and Burn Dressing (59 suppliers)MGP
Occlusive Wound Dressing (120 suppliers)

Identification. An occlusive wound dressing is a nonresorbable, sterile or non-sterile device intended to cover a wound, to provide or support a moist wound environment, and to allow the exchange of gases such as oxygen and water vapor through the device. It consists of a piece of synthetic polymeric material, such as polyurethane, with or without an adhesive backing. This classification does not include an occlusive wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter subject to the limitations in 878.9.

NAD / 878.4020
Occult Blood in Urine Test (25 suppliers)

Identification. An occult blood test is a device used to detect occult blood in urine or feces. (Occult blood is blood present in such small quantities that it can be detected only by chemical tests of suspected material, or by microscopic or spectroscopic examination.)

Classification. Class II (performance standards).

JIO / 864.6550
Occult Blood Reagent (45 suppliers)

Identification. An occult blood test is a device used to detect occult blood in urine or feces. (Occult blood is blood present in such small quantities that it can be detected only by chemical tests of suspected material, or by microscopic or spectroscopic examination.)

Classification. Class II (performance standards).

KHE / 864.6550
Ocular Blood Flow Analyzer, Tonometer (2 suppliers)

Identification. A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.

Classification. Class II.

NJJ / 886.1930
Ocular Esthesiometer (3 suppliers)

Identification. An ocular esthesiometer is a device, such as a single-hair brush, intended to touch the cornea to assess corneal sensitivity.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9.

HJC / 886.1040
Ocular Marker (45 suppliers)

Identification. An ophthalmic surgical marker is a device intended to mark by use of ink, dye, or indentation the location of ocular or scleral surgical manipulation.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9.

HMR / 886.4570
Ocular Peg (4 suppliers)

Identification. An eye sphere implant is a device intended to be implanted in the eyeball to occupy space following the removal of the contents of the eyeball with the sclera left intact.

Classification. Class II.

MQU / 886.3320
Ocular Plethysmograph (4 suppliers)

Identification. An ocular plethysmograph is a device used to measure or detect volume changes in the eye produced by pulsations of the artery, to diagnose carotid artery occlusive disease (restrictions on blood flow in the carotid artery).

Classification. Class III (premarket approval).

JXF / 882.1790
Ocular Pressure Applicator (9 suppliers)

Identification. An ocular pressure applicator is a manual device that consists of a sphygmomanometer-type squeeze bulb, a dial indicator, a band, and bellows, intended to apply pressure on the eye in preparation for ophthalmic surgery.

Classification. Class II.

LCC / 886.4610
Ocular Surgery Irrigation Device (40 suppliers)

Identification. An ocular surgery irrigation device is a device intended to be suspended over the ocular area during ophthalmic surgery to deliver continuous, controlled irrigation to the surgical field.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9.

KYG / 886.4360
Oil Red O Stain (6 suppliers)

Identification. Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.

Classification. Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 864.9. These devices are also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

HZG / 864.1850
Oil Soluble Mounting Media (3 suppliers)KEP / 864.4010
Olfactory Test Kit (1 supplier)NRK / 874.1600
Olive Oil Emulsion Lipase Turbidimetric Method (8 suppliers)

Identification. A lipase test system is a device intended to measure the activity of the enzymes lipase in serum. Lipase measurements are used in diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 862.9.

CET / 862.1465
One-Piece Scalpel (125 suppliers)

Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 878.9.

GDX / 878.4800
One-Way Air-Leak Valve (2 suppliers)OAZ
Operating Room Lamp (14 suppliers)

Identification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.

Classification. Class II.

FQP / 878.4580
Operating Room Scrub Brush (66 suppliers)

Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 878.9.

GEC / 878.4800
Operating Room Shoe Cover (139 suppliers)

Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.

Classification. (1) Class II (special controls) for surgical gowns and surgical masks.

FXP / 878.4040
Operating Room Shoes (25 suppliers)

Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.

Classification. (1) Class II (special controls) for surgical gowns and surgical masks.

FXW / 878.4040
Operating-Room Electrical Table (48 suppliers)

Identification. Operating tables and accessories and operating chairs and accessories are AC-powered or air-powered devices, usually with movable components, intended for use during diagnostic examinations or surgical procedures to support and position a patient.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 878.9.

GDC / 878.4960
Operating-Room Table and Attachments (27 suppliers)

Identification. A manual operating table and accessories and a manual operating chair and accessories are nonpowered devices, usually with movable components, intended to be used to support a patient during diagnostic examinations or surgical procedures.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 878.9.

BWN / 878.4950
Operator Intervention Automated Image Analysis Microscope (5 suppliers)

Identification. Immunohistochemistry test systems (IHC's) are in vitro diagnostic devices consisting of polyclonal or monoclonal antibodies labeled with directions for use and performance claims, which may be packaged with ancillary reagents in kits. Their intended use is to identify, by immunological techniques, antigens in tissues or cytologic specimens. Similar devices intended for use with flow cytometry devices are not considered IHC's.

NOT / 864.1860
Operator Radiation Protector Leaded Screen (10 suppliers)

Identification. A personnel protective shield is a device intended for medical purposes to protect the patient, the operator, or other persons from unnecessary exposure to radiation during radiologic procedures by providing an attenuating barrier to radiation. This generic type of device may include articles of clothing, furniture, and movable or stationary structures.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 892.9.

EAK / 892.6500
Ophthalmic Aberrometer (18 suppliers)

Identification. An ophthalmic refractometer is an automatic AC-powered device that consists of a fixation system, a measurement and recording system, and an alignment system intended to measure the refractive power of the eye by measuring light reflexes from the retina.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9.

NCF / 886.1760
Ophthalmic Absorbable Suture (4 suppliers)HMO
Ophthalmic AC-Powered Fixation Device (11 suppliers)

Identification. A fixation device is an AC-powered device intended for use as a fixation target for the patient during ophthalmological examination. The patient directs his or her gaze so that the visual image of the object falls on the fovea centralis (the center of the macular retina of the eye.)

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9.

HPL / 886.1290
Ophthalmic AC-Powered Instrument Cabinet (6 suppliers)

Identification. An ophthalmic instrument stand is an AC-powered or nonpowered device intended to store ophthalmic instruments in a readily accessible position.

Classification. Class I (general controls). The AC-powered device and the battery-powered device are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The battery-powered device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

HRE / 886.1860
Ophthalmic AC-Powered Instrument Stand (43 suppliers)

Identification. An ophthalmic instrument stand is an AC-powered or nonpowered device intended to store ophthalmic instruments in a readily accessible position.

Classification. Class I (general controls). The AC-powered device and the battery-powered device are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The battery-powered device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

HMF / 886.1860
Ophthalmic AC-Powered Operating Microscope and Accessories (61 suppliers)

Identification. A surgical microscope and accessories is an AC-powered device intended for use during surgery to provide a magnified view of the surgical field.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 878.9.

HRM / 878.4700
Ophthalmic Aspiration Cannula (151 suppliers)

Identification. A manual ophthalmic surgical instrument is a nonpowered, handheld device intended to aid or perform ophthalmic surgical procedures. This generic type of device includes the manual corneal burr, ophthalmic caliper, ophthalmic cannula, eyelid clamp, ophthalmic muscle clamp, iris retractor clip, orbital compressor, ophthalmic curette, cystotome, orbital depressor, lachrymal dilator, erisophake, expressor, ophthalmic forcep, ophthalmic hook, sphere introducer, ophthalmic knife, ophthalmic suturing needle, lachrymal probe, trabeculotomy probe, cornea-sclera punch, ophthalmic retractor, ophthalmic ring (Flieringa), lachrymal sac rongeur, ophthalmic scissors, enucleating snare, ophthalmic spatula, ophthalmic specula, ophthalmic spoon, ophthalmic spud, trabeculotome or ophthalmic manual trephine.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9.

HMX / 886.4350
Ophthalmic Bar Reader (12 suppliers)

Identification. An ophthalmic bar reader is a device that consists of a magnifying lens intended for use by a patient who has impaired vision. The device is placed directly onto reading material to magnify print.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

HJY / 886.5800
Ophthalmic Battery-Powered Electrolysis Unit (4 suppliers)

Identification. An ophthalmic electrolysis unit is an AC-powered or battery-powered device intended to destroy ocular hair follicles by applying a galvanic electrical current.

Classification. Class I for the battery-powered device. Class II for the AC-powered device. The battery-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9.

HPY / 886.4250
Ophthalmic Caliper (110 suppliers)

Identification. A manual ophthalmic surgical instrument is a nonpowered, handheld device intended to aid or perform ophthalmic surgical procedures. This generic type of device includes the manual corneal burr, ophthalmic caliper, ophthalmic cannula, eyelid clamp, ophthalmic muscle clamp, iris retractor clip, orbital compressor, ophthalmic curette, cystotome, orbital depressor, lachrymal dilator, erisophake, expressor, ophthalmic forcep, ophthalmic hook, sphere introducer, ophthalmic knife, ophthalmic suturing needle, lachrymal probe, trabeculotomy probe, cornea-sclera punch, ophthalmic retractor, ophthalmic ring (Flieringa), lachrymal sac rongeur, ophthalmic scissors, enucleating snare, ophthalmic spatula, ophthalmic specula, ophthalmic spoon, ophthalmic spud, trabeculotome or ophthalmic manual trephine.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9.

HOE / 886.4350
Ophthalmic Cannula (153 suppliers)

Identification. A manual ophthalmic surgical instrument is a nonpowered, handheld device intended to aid or perform ophthalmic surgical procedures. This generic type of device includes the manual corneal burr, ophthalmic caliper, ophthalmic cannula, eyelid clamp, ophthalmic muscle clamp, iris retractor clip, orbital compressor, ophthalmic curette, cystotome, orbital depressor, lachrymal dilator, erisophake, expressor, ophthalmic forcep, ophthalmic hook, sphere introducer, ophthalmic knife, ophthalmic suturing needle, lachrymal probe, trabeculotomy probe, cornea-sclera punch, ophthalmic retractor, ophthalmic ring (Flieringa), lachrymal sac rongeur, ophthalmic scissors, enucleating snare, ophthalmic spatula, ophthalmic specula, ophthalmic spoon, ophthalmic spud, trabeculotome or ophthalmic manual trephine.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9.

HMX / 886.4350
Ophthalmic Conformer (34 suppliers)

Identification. An ophthalmic conformer is a device usually made of molded plastic intended to be inserted temporarily between the eyeball and eyelid to maintain space in the orbital cavity and prevent closure or adhesions during the healing process following surgery. ]

Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 886.9.

HQN / 886.3130
Ophthalmic Curette (94 suppliers)

Identification. A manual ophthalmic surgical instrument is a nonpowered, handheld device intended to aid or perform ophthalmic surgical procedures. This generic type of device includes the manual corneal burr, ophthalmic caliper, ophthalmic cannula, eyelid clamp, ophthalmic muscle clamp, iris retractor clip, orbital compressor, ophthalmic curette, cystotome, orbital depressor, lachrymal dilator, erisophake, expressor, ophthalmic forcep, ophthalmic hook, sphere introducer, ophthalmic knife, ophthalmic suturing needle, lachrymal probe, trabeculotomy probe, cornea-sclera punch, ophthalmic retractor, ophthalmic ring (Flieringa), lachrymal sac rongeur, ophthalmic scissors, enucleating snare, ophthalmic spatula, ophthalmic specula, ophthalmic spoon, ophthalmic spud, trabeculotome or ophthalmic manual trephine.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9.

HNZ / 886.4350
Ophthalmic Endoscope (4 suppliers)

Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Classification. (1) Class II (performance standards).

KYH / 876.1500
Ophthalmic Excimer Laser System (13 suppliers)LZS
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