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MEDICAL products beginning with : K
1 to 50 of 198 results  Page: [1] 2 3 4 >> Next 50 Results
 PRODUCT NAMEFDA Code/Regulation 
Kappa FITC (3 suppliers)

Identification. An immunoglobulin (light chain specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques both kappa and lambda types of light chain portions of immunoglobulin molecules in serum, other body fluids, and tissues. In some disease states, an excess of light chains are produced by the antibody-forming cells. These free light chains, unassociated with gamma globulin molecules, can be found in a patient's body fluids and tissues. Measurement of the various amounts of the different types of light chains aids in the diagnosis of multiple myeloma (cancer of antibody-forming cells), lymphocytic neoplasms (cancer of lymphoid tissue), Waldenstrom's macroglobulinemia (increased production of large immunoglobulins), and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus.

Classification. Class II (performance standards).

DEO / 866.5550
Kelly Pad (3 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.

FNW / 878.4370
Kidney Perfusion System (9 suppliers)

Identification. An isolated kidney perfusion and transport system and accesssories is a device that is used to support a donated or a cadaver kidney and to maintain the organ in a near-normal physiologic state until it is transplanted into a recipient patient. This generic type of device may include tubing, catheters, connectors, an ice storage or freezing container with or without bag or preservatives, pulsatile or nonpulsatile hypothermic isolated organ perfusion apparatus with or without oxygenator, and disposable perfusion set.

Classification. Class II (performance standards).

KDN / 876.5880
Kidney Transport Container (3 suppliers)

Identification. An isolated kidney perfusion and transport system and accesssories is a device that is used to support a donated or a cadaver kidney and to maintain the organ in a near-normal physiologic state until it is transplanted into a recipient patient. This generic type of device may include tubing, catheters, connectors, an ice storage or freezing container with or without bag or preservatives, pulsatile or nonpulsatile hypothermic isolated organ perfusion apparatus with or without oxygenator, and disposable perfusion set.

Classification. Class II (performance standards).

KDK / 876.5880
Klebsiella Spp Antiserum (4 suppliers)GTC / 866.3340
Klebsiella Spp. Fluorescent Antisera (2 suppliers)GTB / 866.3340
Knee Cage (24 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.

ITM / 890.3475
Knee Joint Femorotibial Metal/Polymer Non-constrained Cemented Prosthesis (25 suppliers)

Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (888.3027).

Classification. Class II.

HSX / 888.3520
Karyotype Analyzer (4 suppliers)
Kick Bucket Liner (5 suppliers)
Kick Bucket Waste Receptacle (9 suppliers)
Keratome Knife (12 suppliers)
Kinesthesiometer (1 supplier)
Knee Sling (6 suppliers)
Kidney Basin (1 supplier)
Knee Crutch Pads (8 suppliers)
Kidney Stone Filter (3 suppliers)
Knee Course (1 supplier)
Kevorkian Curette (1 supplier)
Knee Wraps (5 suppliers)
Knee Stabilizers (3 suppliers)
Kids Gloves (1 supplier)
Knee Caps (4 suppliers)
Kettlebell Weights (1 supplier)
Kettlebell Storage Racks (1 supplier)
Knee Continuous Passive Motion (2 suppliers)
Kneeling Chairs (1 supplier)
Knee Sleeve Supports (1 supplier)
Knee Sleeves (3 suppliers)
Kelly Forceps (7 suppliers)
Knee Stress Devices (1 supplier)
Ketamine Test Devices (2 suppliers)
Knit Cuff Staff Length Lab Coats (1 supplier)
Knee Length Lab Coats (2 suppliers)
Knit Cuff Knee Length Lab Coats (1 supplier)
Knee Replacement Instruments (1 supplier)
Karyotyping Systems (1 supplier)
Knee Ankle Foot Orthoses (1 supplier)
Knee Pads (6 suppliers)
Knitted Polyester Grafts (2 suppliers)
Knee Disarticulation Prostheses (1 supplier)
Knee Splints (3 suppliers)
Karman Cannulae (1 supplier)
Krypton Systems (1 supplier)
Knee Dressing Holders (1 supplier)
Knuckle Strips (1 supplier)
Knee Orthotic Devices (2 suppliers)
Knee Slide Rehabilitation Devices (1 supplier)
Knee Spreaders (2 suppliers)
Kidney Transplants (1 supplier)
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