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MEDICAL products beginning with : I
101 to 150 of 1656 results  Page: << Previous 50 Results 1 2 [3] 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 >> Next 50 Results
 PRODUCT NAMEFDA Code/Regulation 
Influenza Virus CF Antigen (19 suppliers)

Identification. Influenza virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to influenza in serum. The identification aids in the diagnosis of influenza (flu) and provides epidemiological information on influenza. Influenza is an acute respiratory tract disease, which is often epidemic.

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 866.9.

GNX / 866.3330
Infrared Telethermographic System (1 supplier)

Identification. A telethermographic system for adjunctive diagnostic screening for detection of breast cancer or other uses is an electrically powered device with a detector that is intended to measure, without touching the patient's skin, the self-emanating infrared radiation that reveals the temperature variations of the surface of the body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Classification. Class I (general controls).

IYM / 884.2980
Infusion Catheter (47 suppliers)

Identification. An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.

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.

JCY / 878.4200
Infusion Line Filter (34 suppliers)

Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.

Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled "Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers." Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in 880.9.

FPB / 880.5440
Infusion Pump Accessories (30 suppliers)

Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.

Classification. Class II (performance standards).

MRZ / 880.5725
Infusion Stand (152 suppliers)

Identification. The infusion stand is a stationary or movable stand intended to hold infusion liquids, infusion accessories, and other medical devices.

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.

FOX / 880.6990
Infusion Ultrasound System (2 suppliers)

Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

Classification. Class II (performance standards).

NUI / 870.1200
Inhibin-A Enzyme Immunoassay (3 suppliers)

Identification. An estradiol test system is a device intended to measure estradiol, an estrogenic steroid, in plasma. Estradiol measurements are used in the diagnosis and treatment of various hormonal sexual disorders and in assessing placental function in complicated 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.

NDR / 862.1260
Injectable Bulking Agent (5 suppliers)LNM
Injectable Liquid Silicone (1 supplier)KGM
Injection Cannula (35 suppliers)

Identification. An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.

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.

FGY / 878.4200
Inorganic Phosphorus Phosphomolybdate (36 suppliers)

Identification. A phosphorus (inorganic) test system is a device intended to measure inorganic phosphorus in serum, plasma, and urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.

Classification. Class I.

CEO / 862.1580
Insert Hearing Protector (25 suppliers)EWD
Inspiratory Airway Pressure Meter (7 suppliers)

Identification. An inspiratory airway pressure meter is a device used to measure the amount of pressure produced in a patient's airway during maximal inspiration.

Classification. Class II (performance standards).

BXR / 868.1780
Instestinal Clamp Locking Device (19 suppliers)

Identification. A manual gastroenterology-urology surgical instrument and accessories is a device designed to be used for gastroenterological and urological surgical procedures. The device may be nonpowered, hand-held, or hand-manipulated. Manual gastroenterology-urology surgical instruments include the biopsy forceps cover, biopsy tray without biopsy instruments, line clamp, nonpowered rectal probe, nonelectrical clamp, colostomy spur-crushers, locking device for intestinal clamp, needle holder, gastro-urology hook, gastro-urology probe and director, nonself-retaining retractor, laparotomy rings, nonelectrical snare, rectal specula, bladder neck spreader, self-retaining retractor, and scoop.

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 876.9.

FFR / 876.4730
Instrument Guard (10 suppliers)LXZ
Instrument Surgical Guide (149 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.

FZX / 878.4800
Instrument Surgical Light (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.

FSQ / 878.4580
Instrumentation For Clinical Multiplex Test Systems (10 suppliers)NSU / 862.2570
Insulin Autoantibody Kit (2 suppliers)

Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).

Classification. Class II (performance standards).

OCN / 866.5660
Insulin Bolus Infusion Pump (1 supplier)

Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.

Classification. Class II (performance standards).

OPP / 880.5725
Insulin Infusion Pump (31 suppliers)

Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.

Classification. Class II (performance standards).

LZG / 880.5725
Insulin-Like Growth Factor Binding Protein-1 Immunoassay (3 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.

OAM / 862.1550
Inter-Alpha Trypsin Inhibitor Control (2 suppliers)

Identification. An inter-alpha trypsin inhibitor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the inter-alpha trypsin inhibitor (a protein) in serum and other body fluids. Measurement of inter-alpha trypsin inhibitor may aid in the diagnosis of acute bacterial infection and inflammation.

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 866.9.

CZO / 866.5890
Interactive Wound and Burn Dressing (6 suppliers)MGR
Interconnected Metal Sound (6 suppliers)

Identification. An interlocking urethral sound is a device that consists of two metal sounds (elongated instruments for exploring or sounding body cavities) with interlocking ends, such as with male and female threads or a rounded point and mating socket, used in the repair of a ruptured urethra. The device may include a protective cap to fit over the metal threads.

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 876.9.

FBS / 876.4590
Interferential Current Therapy Unit (51 suppliers)LIH
Intermittent Mandatory Ventilation (IMV) Attachment (6 suppliers)

Identification. An intermittent mandatory ventilation (IMV) attachment is a device attached to a mechanical ventilator that allows spontaneous breathing by a patient while providing mechanical ventilation at a preset rate.

Classification. Class II (performance standards).

CBO / 868.5955
Intermittent Positive Pressure Breathing Device (6 suppliers)

Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.

Classification. Class II (performance standards).

NHJ / 868.5905
Intermittent Pressure Measurement System (24 suppliers)

Identification. An intermittent pressure measurement system is an evaluative device intended for medical purposes, such as to measure the actual pressure between the body surface and the supporting media.

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.

JFC / 890.1600
Internal Atrial Defibrillation Acute Temporary Pacing System (3 suppliers)MTE
Internal Chin Prosthesis (18 suppliers)

Identification. A chin prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the chin.

Classification. Class II.

FWP / 878.3550
Internal Ear Prosthesis (6 suppliers)

Identification. An ear prosthesis is a silicone rubber solid device intended to be implanted to reconstruct the external ear.

Classification. Class II.

FZD / 878.3590
Internal Gauze/Sponge (43 suppliers)EFQ
Internal Inflatable Breast Prosthesis (7 suppliers)

Identification. A silicone inflatable breast prosthesis is a silicone rubber shell made of polysiloxane(s), such as polydimethylsiloxane and polydiphenylsiloxane, that is inflated to the desired size with sterile isotonic saline before or after implantation. The device is intended to be implanted to augment or reconstruct the female breast.

Classification. Class III.

FWM / 878.3530
Internal Non-Inflatable Breast Prosthesis (9 suppliers)FTR / 878.3540
Internal Nose Prosthesis (19 suppliers)

Identification. A nose prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the nasal dorsum.

Classification. Class II.

FZE / 878.3680
Internal Surgical Tape (4 suppliers)MCA
Interstitial Hyperthermia Applicator (2 suppliers)LMZ
Intervertebral Disc Prosthesis (11 suppliers)MJO
Intestinal Stimulator (2 suppliers)LNQ
Intestine Bag (13 suppliers)

Identification. An organ bag is a device that is a flexible plastic bag intended to be used as a temporary receptacle for an organ during surgical procedures to prevent moisture loss.

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.

KGY / 878.4100
Intra-Aortic Balloon System (11 suppliers)

Identification. A intra-aortic balloon and control system is a device that consists of an inflatable balloon, which is placed in the aorta to improve cardiovascular functioning during certain life-threatening emergencies, and a control system for regulating the inflation and deflation of the balloon. The control system, which monitors and is synchronized with the electrocardiogram, provides a means for setting the inflation and deflation of the balloon with the cardiac cycle.

Classification. Class III (premarket approval).

DSP / 870.3535
Intraarticular Hyaluronic Acid (9 suppliers)MOZ
Intracavitary Phonocatheter System (1 supplier)

Identification. An intracavitary phonocatheter system is a system that includes a catheter with an acoustic transducer and the associated device that processes the signal from the transducer; this device records bioacoustic phenomena from a transducer placed within the heart, blood vessels, or body cavities.

Classification. Class II (performance standards).

DXW / 870.1270
Intracompartmental Pressure Monitor (8 suppliers)LXC
Intracranial Neurovascular Stent (8 suppliers)NJE
Intrafallopian Cannula System (2 suppliers)MDG
Intragastric For Morbid Obesity Implant (4 suppliers)LTI
Intraluminal Artery Stripper (12 suppliers)

Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)

Classification. Class II (performance standards).

DWX / 870.4875
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