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MEDICAL products beginning with : E
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 PRODUCT NAMEFDA Code/Regulation 
Estriol Radioimmunoassay Test (16 suppliers)

Identification. An estriol test system is a device intended to measure estriol, an estrogenic steroid, in plasma, serum, and urine of pregnant females. Estriol measurements are used in the diagnosis and treatment of fetoplacental distress in certain cases of high-risk pregnancy.

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.

CGI / 862.1265
Estrogen Receptor Antibody Immunohistochemistry Assay (9 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.

MYA / 864.1860
Estrogen Receptor Assay Kit (1 supplier)

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.

LPJ / 864.1860
Estrone Radioimmunoassay Test (9 suppliers)

Identification. An estrone test system is a device intended to measure estrone, an estrogenic steroid, in plasma. Estrone measurements are used in the diagnosis and treatment of numerous disorders, including infertility, amenorrhea, differentiation of primary and secondary ovarian malfunction, estrogen secreting testicular and ovarian tumors, and precocious puberty in females.

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.

CGF / 862.1280
Ether Dropper (3 suppliers)

Identification. An ether hook is a device that fits inside a patient's mouth and that is intended to deliver vaporized ether.

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 868.9. If the device is not labeled or otherwise represented as sterile, it is 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.

BTP / 868.5420
Ether Hook (4 suppliers)

Identification. An ether hook is a device that fits inside a patient's mouth and that is intended to deliver vaporized ether.

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 868.9. If the device is not labeled or otherwise represented as sterile, it is 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.

BTB / 868.5420
Ethmoid Curettes (18 suppliers)KAO / 874.4420
Ethmoid Punch (15 suppliers)KAX / 874.4420
Ethosuximide Enzyme Immunoassay Test (1 supplier)

Identification. An ethosuximide test system is a device intended to measure ethosuximide, an antiepileptic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of ethosuximide overdose and in monitoring levels of ethosuximide to ensure appropriate therapy.

Classification. Class II.

DLF / 862.3380
Ethyl Alcohol Calibrator Test (8 suppliers)

Identification. A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also 862.2 in this part.)

Classification. Class II.

DNN / 862.3200
Ethyl Alcohol Test (9 suppliers)

Identification. An alcohol test system is a device intented to measure alcohol (e.g., ethanol, methanol, isopropanol, etc.) in human body fluids (e.g., serum, whole blood, and urine). Measurements obtained by this device are used in the diagnosis and treatment of alcohol intoxication and poisoning.

Classification. Class II.

DMJ / 862.3040
Ethyl Eosin (1 supplier)

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.

KJS / 864.1850
Ethylene-Oxide Gas Aerator Cabinet (5 suppliers)

Identification. An ethyene oxide gas aerator cabinet is a device that is intended for use by a health care provider and consists of a cabinet with a ventilation system designed to circulate and exchange the air in the cabinet to shorten the time required to remove residual ethylene oxide (ETO) from wrapped medical devices that have undergone ETO sterilization. The device may include a heater to warm the circulating air.

Classification. Class II (performance standards).

FLI / 880.6100
Ethylene-Oxide Gas Sterilizer (14 suppliers)

Identification. An ethylene gas sterilizer is a nonportable device intended for use by a health care provider that uses ethylene oxide (ETO) to sterilize medical products.

Classification. Class II (performance standards).

FLF / 880.6860
Euglobulin Lysis Test (1 supplier)

Identification. A euglobulin lysis time test is a device that measures the length of time required for the lysis (dissolution) of a clot formed from fibrinogen in the euglobulin fraction (that fraction of the plasma responsible for the formation of plasmin, a clot lysing enzyme). This test evaluates natural fibrinolysis (destruction of a blood clot after bleeding has been arrested). The test also will detect accelerated fibrinolysis.

Classification. Class II (performance standards).

JBO / 864.7275
Eustachian Bougie (3 suppliers)

Identification. A nasopharyngeal catheter is a device consisting of a bougie or filiform catheter that is intended for use in probing or dilating the eustachian tube. This generic type of device includes eustachian catheters.

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 874.9.

KBI / 874.4175
Eustachian Filliform Set (1 supplier)

Identification. A nasopharyngeal catheter is a device consisting of a bougie or filiform catheter that is intended for use in probing or dilating the eustachian tube. This generic type of device includes eustachian catheters.

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 874.9.

KBY / 874.4175
Evaporator (15 suppliers)

Identification. General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use.

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

JRK / 862.2050
Evoked Response Auditory Stimulator (23 suppliers)

Identification. An evoked response auditory stimulator is a device that produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.

Classification. Class II (performance standards).

GWJ / 882.1900
Evoked Response Electrical Stimulator (34 suppliers)

Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.

Classification. Class II (performance standards).

GWF / 882.1870
Evoked Response Mechanical Stimulator (2 suppliers)

Identification. An evoked response mechanical stimulator is a device used to produce a mechanical stimulus or a series of mechanical stimuli for the purpose of measuring a patient's evoked response.

Classification. Class II (performance standards).

GZP / 882.1880
Evoked Response Photic Stimulator (18 suppliers)

Identification. An evoked response photic stimulator is a device used to generate and display a shifting pattern or to apply a brief light stimulus to a patient's eye for use in evoked response measurements or for electroencephalogram (EEG) activation.

Classification. Class II (performance standards).

GWE / 882.1890
Examination and Treatment Chair (51 suppliers)

Identification. A medical chair or table is a device intended for medical purposes that consists of a chair or table without wheels and not electrically powered which, by reason of special shape or attachments, such as food trays or headrests, or special features such as a built-in raising and lowering mechanism or removable arms, is intended for use of blood donors, geriatric patients, or patients undergoing treatment or examination.

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 880.9. 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.

FRK / 880.6140
Examination Gown (191 suppliers)

Identification. An examination gown is a device intended for medical purposes that is made of cloth, paper, or other material that is draped over or worn by a patient as a body covering during a medical examination.

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 880.9. If the device is not labeled or otherwise represented as sterile, it 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.

FME / 880.6265
Exercise Component (106 suppliers)

Identification. An exercise component is a device that is used in conjunction with other forms of exercise and that is intended for medical purposes, such as to redevelope muscles or restore motion to joints or for use as an adjunct treatment for obesity. Examples include weights, dumbbells, straps, and adaptive hand mitts.

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 890.9. 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, regarding general requirements concerning records and 820.198, regarding complaint files.

IOD / 890.5350
Exercise Parallel Bars (16 suppliers)

Identification. Nonmeasuring exercise equipment consist of devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. Examples include a prone scooter board, parallel bars, a mechanical treadmill, an exercise table, and a manually propelled exercise bicycle.

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 890.9. 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, regarding general requirements concerning records and 820.198, regarding complaint files.

IOE / 890.5370
Exophthalmometers (17 suppliers)
Exophthalmometers consist of a calibrated steel bar with four front surface mirrors on each end of the bar. It is used by ophthalmologists for the determination exophtahlmos. It is used to measure the anterior projection of the cornea relative to the lateral orbital rim.

Identification. An exophthalmometer is a device, such as a ruler, gauge, or caliper, intended to measure the degree of exophthalmos (abnormal protrusion of the eyeball).

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.

HLS / 886.1270
Expandable Cervical Dilator (4 suppliers)

Identification. An expandable cervical dilator is an instrument with two handles and two opposing blades used manually to dilate (stretch open) the cervical os.

Classification. Class III (premarket approval).

HDN / 884.4250
Expandable Metalic Colonic Stent (5 suppliers)

Identification. An esophageal prosthesis is a rigid, flexible, or expandable tubular device made of a plastic, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the esophagus. The metal esophageal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.

Classification. Class II. The special control for this device is FDA's "Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses."

MQR / 878.3610
Expandable Tracheal Prosthesis (13 suppliers)

Identification. The tracheal prosthesis is a rigid, flexible, or expandable tubular device made of a silicone, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the trachea or trachealbronchial tree. It may be unbranched or contain one or two branches. The metal tracheal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.

Classification. Class II. The special control for this device is FDA's "Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses."

JCT / 878.3720
Expansive Iris Dilator & Accessories (1 supplier)

Identification. A vitreous aspiration and cutting instrument is an electrically powered device, which may use ultrasound, intended to remove vitreous matter from the vitreous cavity or remove a crystalline lens.

Classification. Class II.

MMC / 886.4150
Explosion-Proof Radiographic Film Illuminator (3 suppliers)

Identification. A radiographic film illuminator is a device containing a visible light source covered with a translucent front that is intended to be used to view medical radiographs.

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.

JAG / 892.1890
Expressor (20 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.

HNS / 886.4350
Extended Wear Soft Contact Lenses (22 suppliers)
Extended wear soft contact lenses are ideal for people with vision problems who do not wish to have surgery and do not like the feel and visual appearance of eyeglasses. These lenses are soft lenses that are made to allow for longer periods of time (about 7 days) without removal and cleaning. These lenses allow more oxygen to pass through to the cornea.

Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.

Classification. (1) Class II if the device is intended for daily wear only.

LPM / 886.5925
Extension Airway Connector (69 suppliers)

Identification. An airway connector is a device intended to connect a breathing gas source to a tracheal tube, tracheostomy tube, or mask.

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 868.9.

BZA / 868.5810
External Aesthetic Restoration Material (9 suppliers)

Identification. An external aesthetic restoration prosthesis is a device intended to be used to construct an external artificial body structure, such as an ear, breast, or nose. Usually the device is made of silicone rubber and it may be fastened to the body with an external prosthesis adhesive. The device is not intended to be implanted.

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. If the device is intended for use without an external prosthesis adhesive to fasten it to the body, the device is 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.

GBI / 878.3800
External Ankle Brace (212 suppliers)

Identification. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement. Examples of limb orthoses include the following: A whole limb and joint brace, a hand splint, an elastic stocking, a knee cage, and a corrective shoe.

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 890.9. 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, regarding general requirements concerning records and 820.198, regarding complaint files.

ITW / 890.3475
External Brace Component Stirrup (22 suppliers)

Identification. An external limb orthotic component is a device intended for medical purposes for use in conjunction with an orthosis (brace) to increase the function of the orthosis for a patient's particular needs. Examples of external limb orthotic components include the following: A brace-setting twister and an external brace stirrup.

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 890.9. 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, regarding general requirements concerning records and 820.198, regarding complaint files.

ITC / 890.3410
External Brace Hip Joint (53 suppliers)

Identification. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement. Examples of limb orthoses include the following: A whole limb and joint brace, a hand splint, an elastic stocking, a knee cage, and a corrective shoe.

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 890.9. 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, regarding general requirements concerning records and 820.198, regarding complaint files.

ITS / 890.3475
External Brace Knee Joint (213 suppliers)

Identification. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement. Examples of limb orthoses include the following: A whole limb and joint brace, a hand splint, an elastic stocking, a knee cage, and a corrective shoe.

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 890.9. 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, regarding general requirements concerning records and 820.198, regarding complaint files.

ITQ / 890.3475
External Breast Expander (1 supplier)MWZ
External Breast Prosthesis (29 suppliers)

Identification. An external aesthetic restoration prosthesis is a device intended to be used to construct an external artificial body structure, such as an ear, breast, or nose. Usually the device is made of silicone rubber and it may be fastened to the body with an external prosthesis adhesive. The device is not intended to be implanted.

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. If the device is intended for use without an external prosthesis adhesive to fasten it to the body, the device is 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.

KCZ / 878.3800
External Cardiac Compressor (9 suppliers)

Identification. An external cardiac compressor is an external device that is electrically, pneumatically, or manually powered and is used to compress the chest periodically in the region of the heart to provide blood flow during cardiac arrest.

Classification. Class III (premarket approval).

DRM / 870.5200
External Component Thigh Socket Prosthesis (23 suppliers)

Identification. An external limb prosthetic component is a device intended for medical purposes that, when put together with other appropriate components, constitutes a total prosthesis. Examples of external limb prosthetic components include the following: Ankle, foot, hip, knee, and socket components; mechanical or powered hand, hook, wrist unit, elbow joint, and shoulder joint components; and cable and prosthesis suction valves.

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 890.9. 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, regarding general requirements concerning records and 820.198, regarding complaint files.

ISS / 890.3420
External Counterpulsating Pump (9 suppliers)

Identification. An external counter-pulsating device is a noninvasive device used to assist the heart by applying positive or negative pressure to one or more of the body's limbs in synchrony with the heart cycle.

Classification. Class III (premarket approval).

DRN / 870.5225
External Eyelid Weights (11 suppliers)MML
External Facial Fracture Appliance (3 suppliers)

Identification. An external facial fracture fixation appliance is a metal apparatus intended to be used during surgical reconstruction and repair to immobilize maxillofacial bone fragments in their proper facial relationship.

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.

FYI / 878.3250
External Fixator (With Metallic Invasive Components) System (1 supplier)

Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Classification. Class II.

NDK / 888.3040
External Functional Neuromuscular Stimulator (36 suppliers)

Identification. An external functional neuromuscular stimulator is an electrical stimulator that uses external electrodes for stimulating muscles in the leg and ankle of partially paralyzed patients (e.g., after stroke) to provide flexion of the foot and thus improve the patient's gait.

Classification. Class II (performance standards).

GZI / 882.5810
External Gauge (26 suppliers)GER
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