A  B  C  D  E  F  G  H  I  J  K  L  M  N  O  P  Q  R  S  T  U  V  W  X  Y  Z  FDA Codes
MEDICAL products beginning with : N
1 to 50 of 1284 results  Page: [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 
N-Acetylprocainamide Enzyme Immunoassay Test (7 suppliers)

Identification. A digoxin test system is a device intended to measure digoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.

Classification. Class II.

LAN / 862.3320
N. Gonorrhoeae (All Groups) Fluorescent (Direct Test) Antiserum (1 supplier)GTH / 866.3390
N. Meningitidis Antisera (5 suppliers)GTJ / 866.3390
N. Meningitidis Fluorescent Antisera (2 suppliers)GTI / 866.3390
N95 Respirator For Use By The General Public In Public Health Medical Emergencies (2 suppliers)NZJ / 880.6260
N95 Respirator With Antimicrobial/Antiviral Agent (3 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.

ONT / 878.4040
NAD/NADH Reagent for Alcohol Enzume Method (7 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.

DML / 862.3040
Nadh Oxidation/Nad Reduction (49 suppliers)

Identification. An alanine amino transferase (ALT/SGPT) test system is a device intended to measure the activity of the enzyme alanine amino transferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and plasma. Alanine amino transferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.

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.

CKA / 862.1030
Nail Extractors (88 suppliers)

Identification. An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.

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 888.9.

HWB / 888.4540
Nail Prosthesis (1 supplier)MQZ
Nail/Blade/Plate Appliance (5 suppliers)

Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Classification. Class II.

KWK / 888.3030
Nail/Blade/Plate Component Fixation Appliance (19 suppliers)

Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Classification. Class II.

LXT / 888.3030
Narrow Band Spectrum Endoscope Accessories (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).

NWB / 876.1500
Nasal Chisel (57 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.

KAN / 878.4800
Nasal Curette (51 suppliers)KAP / 874.4420
Nasal Dilator (44 suppliers)

Identification. A nasal dilator is a device intended to provide temporary relief from transient causes of breathing difficulties resulting from structural abnormalities and/or transient causes of nasal congestion associated with reduced nasal airflow. The device decreases airway resistance and increases nasal airflow. The external nasal dilator is constructed from one or more layers of material upon which a spring material is attached, with a skin adhesive applied to adhere to the skin of the nose; it acts with a pulling action to open the nares. The internal nasal dilator is constructed from metal or plastic and is placed inside the nostrils; it acts by pushing the nostrils open or by gently pressing on the columella.

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.

LWF / 874.3900
Nasal Flowmeter (1 supplier)ETL
Nasal Inhaler (54 suppliers)

Identification. An ear, nose, and throat drug administration device is one of a group of ear, nose, and throat devices intended specifically to administer medicinal substances to treat ear, nose, and throat disorders. These instruments include the powder blower, dropper, ear wick, manual nebulizer pump, and nasal inhaler.

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. 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.

KCO / 874.5220
Nasal Knife (53 suppliers)KAS / 874.4420
Nasal Punch (44 suppliers)KAY / 874.4420
Nasal Rasps (63 suppliers)KBA / 874.4420
Nasal Rongeur (49 suppliers)KBB / 874.4420
Nasal Saw (47 suppliers)KBC / 874.4420
Nasal Scissors (115 suppliers)KBD / 874.4420
Nasal Scissors Straight (107 suppliers)KBD / 874.4420
Nasal Septal Button (11 suppliers)LFB
Nasal Snare (53 suppliers)KBE / 874.4420
Nasal Splints (50 suppliers)

Identification. An external nasal splint is a rigid or partially rigid device intended for use externally for immobilization of parts of the nose.

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.

EPP / 874.5800
Nasogastric Tubes (21 suppliers)

Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).

Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory is exempt from the premarket notification procedures in subpart E of this part subject to the limitations in 876.9.

BSS / 876.5980
Nasopharyngeal Airways (48 suppliers)
Nasopharyngeal airway is a tube that is designed to be inserted into the nasal passageway to secure an open airway. These are used by people who have sleep apnea. These devices are also used by emergency care professionals such as paramedics in situations where an artificial form of airway maintenance is necessary. The purpose of the flared end is to prevent the device from becoming lost inside the patient's head.

Identification. A nasopharyngeal airway is a device used to aid breathing by means of a tube inserted into a patient's pharynx through the nose to provide a patent airway.

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.

BTQ / 868.5100
Nasopharyngeal Catheter (7 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.

ENW / 874.4175
Nasopharyngeal Electrodes (6 suppliers)

Identification. A nasopharyngeal electrode is an electrode which is temporarily placed in the nasopharyngeal region for the purpose of recording electrical activity.

Classification. Class II (performance standards).

GZK / 882.1340
Natriuretic Peptide Test (16 suppliers)

Identification. The B-type natriuretic peptide (BNP) test system is an in vitro diagnostic device intended to measure BNP in whole blood and plasma. Measurements of BNP are used as an aid in the diagnosis of patients with congestive heart failure.

Classification. Class II (special controls). The special control is "Class II Special Control Guidance Document for B-Type Natriuretic Peptide Premarket Notifications; Final Guidance for Industry and FDA Reviewers."

NBC / 862.1117
Natural Absorbable Suture (35 suppliers)

Identification. An absorbable surgical gut suture, both plain and chromic, is an absorbable, sterile, flexible thread prepared from either the serosal connective tissue layer of beef (bovine) or the submucosal fibrous tissue of sheep (ovine) intestine, and is intended for use in soft tissue approximation.

Classification. Class II (special controls). The special control for this device is FDA's "Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA." See 878.1(e) for the availability of this guidance document.

GAL / 878.4830
Nearpoint Ruler (13 suppliers)

Identification. A nearpoint ruler is a device calibrated in centimeters intended to measure the nearpoint of convergence (the point to which the visual lines are directed when convergence is at its maximum).

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.

HLE / 886.1790
Needle Destruction Device (4 suppliers)
Mobile needle destruction device is a compact, lightweight and portable device used in mobile applications. It significantly reduces the danger of accidental needle sticks. It disintegrates the entire sharp needle portion of hypodermic syringe. Its four rubber pads secure the unit from moving when placed on a flat surface.
MTV
Needle Electrode (51 suppliers)

Identification. A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.

Classification. Class II (performance standards).

GXZ / 882.1350
Needle-Type High-Frequency Epilator (26 suppliers)

Identification. A needle-type epilator is a device intended to destroy the dermal papilla of a hair by applying electric current at the tip of a fine needle that has been inserted close to the hair shaft, under the skin, and into the dermal papilla. The electric current may be high-frequency AC current, high-frequency AC combined with DC current, or DC current only.

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.

KCW / 878.5350
Negative Control Serological Kit (1 supplier)

Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Classification. Class I (general controls). Except when used in donor screening tests, unassayed material is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 862.9.

MJY / 862.1660
Negative Pressure Wound Therapy Powered Suction Pump (20 suppliers)OMP
Neisseria Controls (2 suppliers)

Identification. A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.

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.

LSC / 866.2660
Neisseria DNA Reagents (7 suppliers)LSL / 866.3390
Neisseria Gonorrhoeae Antiserum (3 suppliers)LIC / 866.3390
Neisseria Gonorrhoeae Biochemical Reagent Test (4 suppliers)

Identification. A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.

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.

LTS / 866.2660
Neisseria Gonorrhoeae Enzyme Linked Immunoabsorbent Assay (2 suppliers)LIR / 866.3390
Neisseria Gonorrhoeae Identification Kit (12 suppliers)

Identification. A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.

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.

JSX / 866.2660
Neonatal Apnea Monitor (17 suppliers)

Identification. An apnea monitor is a complete system intended to alarm primarily upon the cessation of breathing timed from the last detected breath. The apnea monitor also includes indirect methods of apnea detection such as monitoring of heart rate and other physiological parameters linked to the presence or absence of adequate respiration.

Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled "Class II Special Controls Guidance Document: Apnea Monitors; Guidance for Industry and FDA."

FLS / 868.2377
Neonatal Eye Pad (19 suppliers)

Identification. A neonatal eye pad is an opaque device used to cover and protect the eye of an infant during therapeutic procedures, such as phototherapy.

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 880.9. 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 of this chapter, with respect to general requirements concerning records, and 820.198 of this chapter, with respect to complaint files.

FOK / 880.5270
Neonatal Incubators (20 suppliers)

Identification. A neonatal incubator is a device consisting of a rigid boxlike enclosure in which an infant may be kept in a controlled environment for medical care. The device may include an AC-powered heater, a fan to circulate the warmed air, a container for water to add humidity, a control valve through which oxygen may be added, and access ports for nursing care.

Classification. Class II (performance standards).

FMZ / 880.5400
Neonatal Incubators (36 suppliers)

Identification. A neonatal incubator is a device consisting of a rigid boxlike enclosure in which an infant may be kept in a controlled environment for medical care. The device may include an AC-powered heater, a fan to circulate the warmed air, a container for water to add humidity, a control valve through which oxygen may be added, and access ports for nursing care.

Classification. Class II (performance standards).

FMZ / 880.5400
1 to 50 of 1284 results  Page: [1] 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 >> Next 50 Results
Browse Category   |   Alphabetical Products   |   ALL 25,000 Suppliers
HomeBuyAdd FREE ListingAdvertise Medical CompanyMedical Portal