Kmedic

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Web: http://www.kmedic.com
E-Mail:
Address: 190 Veterans Drive, Northvale, New Jersey 07647, USA
Phone: +1-(201)-767-4002 | Fax: +1-(201)-768-0494 | Map/Directions >>
 
 

Profile: Kmedic produces & supply instruments for sutures, ligation, chest drains, surgical, wound closure systems, cardiac surgery and anesthesiology. We are an ISO 9001 certified company. We offer products like vascular access, respiratory, anesthesia, surgery, urology & cardiac assist. The respiratory assists to make breathing easier. Teleflex medical strives to advance patient care by focusing on caregiver efficiency. Our goal is to advance patient safety and ultimately achieve the best patient outcome by incorporating the needs of the caregiver into every product we make. We concentrate in orthopedic surgical instruments. We have created definitive resources for instrumentation used in orthopedic, hand, spinal & foot and ankle procedures.

The company was founded in 1986, has revenues of < USD 1 Million and is ISO certified. AMEX:TFX (SEC Filings)

FDA Registration Number: 3012164475

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• 80 Vertical Microscissors
• Absorbable Hemostats Surgicel
• AC-Powered Motor Orthopedic Surgical Instrument (FDA Code: HWE / 878.4820)
Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.
• Adjustable Bone Holding Forceps
• Adjustable Frequency Tuning Fork
• Adson 1 x 2 Teeth Tissue Forceps
• Adson Tissue Forceps
• Adson-Graefe Tissue Forceps
• Adult Muscle Forceps
• All-Purpose Foreign Body Forceps
• Alligator Forceps
• Aluminium Tuning Fork
• Amputation Knife (FDA Code: GDN / 878.4800)
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.
• Angled Biopsy Punch
• Angled Micro Capsulorhexis Forceps
• Angled Micro Tying Forceps
• Angled tying utility Forceps
• Angular Ear Curette
• Anterior chamber utility Forceps
• Atraumatic Hemostatic Forceps
• Atraumatic Tissue Forceps
• Automatic Clip Appliers
• Automatic Clip Appliers With Titanium Interlock
• Automatic Wire Twisters
• Awl (FDA Code: HWJ / 888.4540)
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.
• Baby Metzenbaum Scissors
• Bandage/Gauze/Plaster Scissors (Cutter, Shears)
• Bender (FDA Code: HXW / 888.4540)
• Biopsy Forceps, Internal Jugular Approach 7
• Biopsy Punch (FDA Code: FCI / 876.1075)
A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
• Biopsy Punch Forceps
• Biopsy Punch Tray
• Biopsy Punches (FDA Code: FCI / 876.1075)
• BiPolar Bayonet Forceps
• Bipolar Forceps, Handswitching
• Bipolar Sterilization Tray
• Blood Collection Sets with Needle Holder
• Blood Needle Holder Systems
• Bone Awls and Probes
• Bone Chisels
• Bone Clamp (FDA Code: HXD / 878.4800)
• Bone Curettes
• Bone Cutters
• Bone Fixation Plate (FDA Code: HRS / 888.3030)
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.
• Bone Fixation Screw (FDA Code: HWC / 888.3040)
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.
• Bone Holding and Plate Holding Forceps
• Bone Holding Forceps
• Bone Hooks (FDA Code: KIK / 878.4800)
• Bone Mallet Solid Stainless Head
• Bone Mallets (FDA Code: HXL / 878.4800)

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