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MEDICAL products beginning with : P
351 to 400 of 3511 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 
Protein-Bound Iodine Dry Ash Method (1 supplier)

Identification. A protein-bound iodine test system is a device intended to measure protein-bound iodine in serum. Measurements of protein-bound iodine obtained by this device are used in the diagnosis and treatment of thyroid disorders.

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 862.9.

JIK / 862.1640
Protein-Bound Iodine Wet Ash Method (1 supplier)

Identification. A protein-bound iodine test system is a device intended to measure protein-bound iodine in serum. Measurements of protein-bound iodine obtained by this device are used in the diagnosis and treatment of thyroid disorders.

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 862.9.

JIJ / 862.1640
Proteus Spp Fluorescent Antisera (4 suppliers)GSY / 866.3410
Prothrombin Antigen (5 suppliers)

Identification. A prothrombin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the prothrombin (clotting factor II) in serum. Measurements of the amount of antigenically competent (ability to react with protein antibodies) prothrombin aid in the diagnosis of blood-clotting disorders.

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. This exemption does not apply to multipurpose systems for in vitro coagulation studies classified under 864.5425 of this chapter or prothrombin time tests classified under 864.7750 of this chapter.

DDF / 866.5735
Prothrombin Fragment 1.2 (2 suppliers)

Identification. A fibrinogen/fibrin degradation products assay is a device used to detect and measure fibrinogen degradation products and fibrin degradation products (protein fragments produced by the enzymatic action of plasmin on fibrinogen and fibrin) as an aid in detecting the presence and degree of intravascular coagulation and fibrinolysis (the dissolution of the fibrin in a blood clot) and in monitoring therapy for disseminated intravascular coagulation (nonlocalized clotting in the blood vessels).

Classification. Class II (performance standards).

MIF / 864.7320
Prothrombin Time Test (26 suppliers)

Identification. A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).

Classification. Class II (performance standards).

GJS / 864.7750
Protoporphyrin Fluorometric Test (1 supplier)

Identification. A lead test system is a device intended to measure lead, a heavy metal, in blood and urine. Measurements obtained by this device are used in the diagnosis and treatment of lead poisoning.

Classification. Class II.

DMK / 862.3550
Protractor (14 suppliers)

Identification. A protractor for clinical use is a device intended for use in measuring the angles of bones, such as on x-rays or in surgery.

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.

HTH / 888.4600
Proximal Femoral Fixation Implant Device (22 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.

JDO / 888.3030
Pseudomonas Aeruginosa Fluorescent Antisera Test (3 suppliers)GSS / 866.3415
Pseudomonas Pseudomallei Antiserum (1 supplier)GST / 866.3415
Pseudomonas Pseudomallei Fluorescent Antisera (1 supplier)GSR / 866.3415
Psittacosis CF Antigen (2 suppliers)

Identification. Chlamydia serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to chlamydia in serum. Additionally, some of these reagents consist of chlamydia antisera conjugated with a fluorescent dye used to identify chlamydia directly from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genusChlamydia and provides epidemiological information on these diseases. Chlamydia are the causative agents of psittacosis (a form of pneumonia), lymphogranuloma venereum (a venereal disease), and trachoma (a chronic disease of the eye and eyelid).

Classification. Class I (general controls).

GPW / 866.3120
Psittacosis CF Antiserum (1 supplier)

Identification. Chlamydia serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to chlamydia in serum. Additionally, some of these reagents consist of chlamydia antisera conjugated with a fluorescent dye used to identify chlamydia directly from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genusChlamydia and provides epidemiological information on these diseases. Chlamydia are the causative agents of psittacosis (a form of pneumonia), lymphogranuloma venereum (a venereal disease), and trachoma (a chronic disease of the eye and eyelid).

Classification. Class I (general controls).

GPT / 866.3120
PTFE/Carbon-Fiber Prosthesis (3 suppliers)

Identification. A polytetrafluoroethylene with carbon fibers composite implant material is a porous device material intended to be implanted during surgery of the chin, jaw, nose, or bones or tissue near the eye or ear. The device material serves as a space-occupying substance and is shaped and formed by the surgeon to conform to the patient's need.

Classification. Class II.

KDA / 878.3500
Ptosis Crutch (3 suppliers)

Identification. A ptosis crutch is a device intended to be mounted on the spectacles of a patient who has ptosis (drooping of the upper eyelid as a result of faulty development or paralysis) to hold the upper eyelid open.

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.

HJZ / 886.5600
Pudendal Anesthesia Kit (4 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).

HEG / 884.5100
Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter (2 suppliers)

Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Classification. Class II (performance standards).

OMZ / 870.1250
Pulmonary Function Data Calculator (24 suppliers)

Identification. A pulmonary-function data calculator is a device used to calculate pulmonary-function values based on actual physical data obtained during pulmonary-function testing.

Classification. Class II (performance standards).

BZC / 868.1880
Pulmonary Function Predicted Values Calculator (13 suppliers)

Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.

Classification. Class II (performance standards).

BTY / 868.1890
Pulmonary Pneumotachometer (5 suppliers)

Identification. A pneumotachometer is a device intended for medical purposes that is used to determine gas flow by measuring the pressure differential across a known resistance. The device may use a set of capillaries or a metal screen for the resistive element.

Classification. Class II (performance standards).

JAX / 868.2550
Pulmonary Surgical Neodymium YAG Laser (3 suppliers)

Identification. An ear, nose, and throat microsurgical carbon dioxide laser is a device intended for the surgical excision of tissue from the ear, nose, and throat area. The device is used, for example, in microsurgical procedures to excise lesions and tumors of the vocal cords and adjacent areas.

Classification. Class II.

LLO / 874.4500
Pulmonic Valved Conduit (1 supplier)MWH
Punctum Plug (15 suppliers)LZU
Pure Latex Sheet with Self-Retaining Finger Cot (7 suppliers)

Identification. A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.

Classification. Class II.

EYX / 878.4370
Purple Bromcresol Albumin Dye-Binding Test (9 suppliers)

Identification. An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

Classification. Class II.

CJW / 862.1035
Pyronin Stain (5 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.

HZP / 864.1850
Paraffin Knife (1 supplier)
Periodic Acid Schiff (PAS) Stain (1 supplier)
Pelvic Support Belt (11 suppliers)
Portable Heating Pad Unit (3 suppliers)
Powered Myoelectric Biofeedback Equipment (6 suppliers)
Powered Radiographic Cradle (1 supplier)
Positron Emission Tomography (PET) Scanner (10 suppliers)
Photofluoroscope (1 supplier)
Percutaneous Endoscopic Gastrostomy Kit (1 supplier)
Perineal Irrigation Kit (2 suppliers)
Perineal Irrigator (1 supplier)
Parenteral Administration Kit (2 suppliers)
Parenteral Nutrition Solution (6 suppliers)
Pediatric Ultrasonic Scanner (7 suppliers)
Penetrometer (2 suppliers)
Pneumoencephalographic Chair (1 supplier)
Polytomographic Diagnostic Radiographic Unit (1 supplier)
Portable (X-Ray) Diagnostic Radiographic Unit (3 suppliers)
Portable X-Ray Shield (9 suppliers)
Portable N class Autoclave Sterilizer (1 supplier)
Polystyrene Test Tubes (1 supplier)
Polypropylene Test Tubes (1 supplier)
Polystyrene Pipettes (1 supplier)
351 to 400 of 3511 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
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