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Biomet, Inc

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Web: http://www.biomet.com/orthopedics
E-Mail:
Address: PO Box 587, Warsaw, Indiana 46581-0587, USA
Phone: +1-(574)-267-6639 | Map/Directions >>
 
 

Profile: Biomet, Inc designs and manufactures products for hip replacement, knee replacement, shoulder replacement, elbow replacement & other small joint replacements. We are an ISO 9001 CE certified company. We offer products like joint replacement, sports medicine & dental implants. We encourage you to talk to your doctor about options that could help you get back to living and keep you active. If you have suffered from a sports related or other injury, we can help. Sports knee injuries and the available treatment options is the first step to making an informed decision about your healthcare and your quality of life. Our recommendation is to see an orthopedic physician who, after an examination, can give you the appropriate treatment options for your medical condition. Our Repicci II® implant system resurfaces only the damaged section of cartilage, thus saving a healthy cartilage. Our BioSymMetRic™ PIP fixator is a device that uses pins placed through the finger bone to stabilize complex finger fractures.

The company was founded in 1977, has revenues of > USD 1 Billion, has ~20 employees and is ISO 9001, CE certified. NASDAQ:BMET (SEC Filings)

FDA Registration Number: 1825034

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• Nail/Blade/Plate Component Fixation Appliance (FDA Code: LXT / 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.
• Nails & Screws
• Nasal Splint Kits
• Nasal Splints (FDA Code: EPP / 874.5800)
An external nasal splint is a rigid or partially rigid device intended for use externally for immobilization of parts of the nose.
• Neonatal Disposable Blood Pressure Cuffs
• Neoprene Back Support
• Nerve Conduction Velocity Measurement Device (FDA Code: JXE / 882.1550)
A nerve conduction velocity measurement device is a device which measures nerve conduction time by applying a stimulus, usually to a patient's peripheral nerve. This device includes the stimulator and the electronic processing equipment for measuring and displaying the nerve conduction time.
• Nerve Cuff (FDA Code: JXI / 882.5275)
A nerve cuff is a tubular silicone rubber sheath used to encase a nerve for aid in repairing the nerve (e.g., to prevent ingrowth of scar tissue) and for capping the end of the nerve to prevent the formation of neuroma (tumors).
• Neurological Stereotaxic Instrument (FDA Code: HAW / 882.4560)
A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.
• Neurology Self-Retaining Retractor (FDA Code: GZT / 882.4800)
A self-retaining retractor for neurosurgery is a self-locking device used to hold the edges of a wound open during neurosurgery.
• Neurosurgery Surgical Drapes
• Non Dental Irrigating Syringe (FDA Code: KYZ / 880.6960)
An irrigating syringe is a device intended for medical purposes that consists of a bulb or a piston syringe with an integral or a detachable tube. The device is used to irrigate, withdraw fluid from, or instill fluid into, a body cavity or wound.
• Non-absorbable Suture Anchors
• Non-Alterable Preformed Skull Bone Plate (FDA Code: GXN / 882.5330)
A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.
• Non-ice Cold Packs
• Non-Invasive Electric Osteogenesis Stimulator
• Non-Invasive Tubing (FDA Code: GAZ / 880.6740)
A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).
• Non-Penetrating Non-Powered Hip Traction Unit (FDA Code: HSR / 888.5890)
A noninvasive traction component is a device, such as a head halter, pelvic belt, or a traction splint, that does not penetrate the skin and is intended to assist in connecting a patient to a traction apparatus so that a therapeutic pulling force may be applied to the patient's body.
• Non-Powered Goniometer (FDA Code: KQW / 888.1520)
A nonpowered goniometer is a mechanical device intended for medical purposes to measure the range of motion of joints.
• Non-Powered Portable Single Patient Suction Apparatus (FDA Code: GCY / 878.4680)
A nonpowered, single patient, portable suction apparatus is a device that consists of a manually operated plastic, disposable evacuation system intended to provide a vacuum for suction drainage of surgical wounds.
• Non-Powered Traction Apparatus (FDA Code: HST / 888.5850)
A nonpowered orthopedic traction apparatus is a device that consists of a rigid frame with nonpowered traction accessories, such as cords, pulleys, or weights, and that is intended to apply a therapeutic pulling force to the skeletal system.
• Non-reinforced Surgical Gowns
• Nut Bolt Washer (FDA Code: HTN / 888.3030)
• Occupational Back Support
• Operating Room Equipment Specialty Drapes
• Ophthalmic Surgical Drapes
• Ophthalmology, Surgical Instrument Trays
• Orbital Procedures, Bone Drills
• Orthopaedic Instrument, Universal Bone Drill
• Orthopedic Burr (FDA Code: HTT / 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.
• Orthopedic Cutting Instrument (FDA Code: HTZ / 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.
• Orthopedic Implant Material (FDA Code: MOO)
• Orthopedic instruments, total knee Systems
• Orthopedic Manual Surgical Instrument (FDA Code: LXH / 888.4540)
• Orthopedic Needle Holder (FDA Code: HXK / 888.4540)
• Orthopedic Osteotome (FDA Code: HWM / 878.4800)
• Orthopedic Pin System
• Orthopedic Plating System
• Orthopedic Prosthesis Implantation Instrument
• Orthopedic Surgical Drapes
• Orthopedic Wire Passer (FDA Code: HXI / 888.4540)
• Orthopedics Implants Fibular IM Nails
• Orthopedics, High Speed Drills System
• Osteophilic Finish Cemented/Non-porous Cemented Semi-constrained Hip Prosthesis (FDA Code: MAY / 888.3353)
A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A1203) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.
• Osteophilic Finish Uncemented Semi- Hip Prosthesis (FDA Code: MBL / 888.3358)
A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.
• Overhead Supported Arm Sling (FDA Code: ILE / 890.3475)
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.
• Padded Aluminium External Nasal Splint
• Padded Arm Sling
• Pain Management Kits
• Panel Elastic Abdominal Binder

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