Profile: Medtronic Xomed Surgical Products, Inc develops products that treat people with ear, nose and throat (ENT) diseases. our products include MeroPack®, Bioresorbable Nasal Dressing and Sinus Stent, Integrated Power Console System, Pillar® System, Big Easy® Piston, and ENT-5000 Video Endoscopy System. The ENT video Endoscopy system includes lightweight, 3 mm distal tip and insertion tube, Full screen presentation, Optional stroboscope, Optional transNasal esophagoscope. Our EndoSheath® Technology provides a sterile insertion tube for every patient, alternative to time-consuming reprocessing, Increases productivity for your practice, and increases protection.

The company was founded in 1999, has revenues of USD 500 Million to 1 Billion, has ~650 employees and is ISO 9001, CE certified. NASDAQ:XOMD (SEC Filings)

FDA Registration Number: 1045254

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• General & Plastic Surgery Biopsy Brush (FDA Code: GEE / 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.

• General & Plastic Surgery Forceps (FDA Code: GEN / 878.4800)

• General & Plastic Surgery Laparoscope (FDA Code: GCJ / 876.1500) 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.

• General & Plastic Surgery Mirror (FDA Code: FTX / 878.4800)

• General & Plastic Surgery Surgical Burr (FDA Code: GFF / 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.

• General & Plastic Surgery Surgical Cannula (FDA Code: GEA / 878.4800)

• General & Plastic Surgery Surgical Clamp (FDA Code: GDJ / 878.4800)

• General & Plastic Surgery Surgical Dissector (FDA Code: GDI / 878.4800)

• General & Plastic Surgery Surgical Elevator (FDA Code: GEG / 878.4800)

• General & Plastic Surgery Surgical File (FDA Code: GEO / 878.4800)

• General & Plastic Surgery Surgical Gouge (FDA Code: GDH / 878.4800)

• General & Plastic Surgery Surgical Hook (FDA Code: GDG / 878.4800)

• General & Plastic Surgery Surgical Mallet (FDA Code: GFJ / 878.4800)

• General & Plastic Surgery Surgical Rasp (FDA Code: GAC / 878.4800)

• General & Plastic Surgery Surgical Spatula (FDA Code: GAF / 878.4800)

• General Diagnostic Supplies

• General Manual Obstetric/Gynecologic Instrument (FDA Code: KOH / 884.4520) An obstetric-gynecologic general manual instrument is one of a group of devices used to perform simple obstetric and gynecologic manipulative functions. This generic type of device consists of the following:

• General Surgical Aids

• General Surgical Instruments

• General Surgical Manual Instrument (FDA Code: MDM / 878.4800)

• General Surgical Scissors (FDA Code: LRW / 878.4800)

• General use Surgical Curettes (FDA Code: FZS / 878.4800)

• Glucose Oxidase, Glucose (FDA Code: CGA / 862.1345) A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

• Guidewire Catheter (FDA Code: DQX / 870.1330) A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.

• Guiding Probes

• Gynecologic Laparoscope and Accessories (FDA Code: HET / 884.1720) A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.

• Hand Splint and Component (FDA Code: ILH / 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.

• Heart Stabilizer (FDA Code: MWS / 870.4500) Cardiovascular surgical instruments are surgical instruments that have special features for use in cardiovascular surgery. These devices include, e.g., forceps, retractors, and scissors.

• Heart Valve Prosthesis Holder (FDA Code: DTJ / 870.3935) A prosthetic heart valve holder is a device used to hold a replacement heart valve while it is being sutured into place.

• Heart Valve Prosthesis Sizer (FDA Code: DTI / 870.3945) A prosthetic heart valve sizer is a device used to measure the size of the natural valve opening to determine the size of the appropriate replacement heart valve.

• Heart-Valve, Non-Allograft Tissue (FDA Code: LWR)

• Hemostatic Clip Applier (FDA Code: HBT / 878.4800)

• Human Bone Rasps (FDA Code: HTR / 878.4800)

• Hydraulic Surgical Table (FDA Code: FWY / 878.4950) A manual operating table and accessories and a manual operating chair and accessories are nonpowered devices, usually with movable components, intended to be used to support a patient during diagnostic examinations or surgical procedures.

• I.V. Container (FDA Code: KPE / 880.5025) An I.V. container is a container made of plastic or glass used to hold a fluid mixture to be administered to a patient through an intravascular administration set.

• Iliac Stent (FDA Code: NIO)

• Illuminated Speculum (FDA Code: FXF / 878.1800) A speculum is a device intended to be inserted into a body cavity to aid observation. It is either nonilluminated or illuminated and may have various accessories.

• Impactor (FDA Code: HWA / 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.

• Implantable Cardiac Event Recorder (Without Arrhythmia Detection) (FDA Code: MXC / 870.2800) A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.

• Implantable Clip (FDA Code: FZP / 878.4300) An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.

• Implantable Clip For Coronary Artery Bypass Graft (Cabg) (FDA Code: NCA / 878.4300)

• Implantable Electrical Stimulator (FDA Code: EZW / 876.5270) An implanted electrical urinary device is a device intended for treatment of urinary incontinence that consists of a receiver implanted in the abdomen with electrodes for pulsed-stimulation that are implanted either in the bladder wall or in the pelvic floor, and a battery-powered transmitter outside the body.

• Implantable Permanent Pulse Generator (FDA Code: NVZ)

• Implantable Spinal Cord Stimulator (FDA Code: GZB / 882.5880) An implanted spinal cord stimulator for pain relief is a device that is used to stimulate electrically a patient's spinal cord to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed on the patient's spinal cord and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.

• Implanted Electrical Stimulator (FDA Code: MHY)

• Implanted Peripheral Nerve Stimulator (FDA Code: GZF / 882.5870) An implanted peripheral nerve stimulator for pain relief is a device that is used to stimulate electrically a peripheral nerve in a patient to relieve severe intractable pain. The stimulator consists of an inplanted receiver with electrodes that are placed around a peripheral nerve and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.

• Implanted Programmable Infusion Pump (FDA Code: LKK)

• Implanted Subcortical Electrical Stimulator (Motor Disorders) (FDA Code: MRU)

• Implanted Subcutaneous Intravascular Port & Catheter (FDA Code: LJT / 880.5965) A subcutaneous, implanted, intravascular infusion port and catheter is a device that consists of a subcutaneous, implanted reservoir that connects to a long-term intravascular catheter. The device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood. The device consists of a portal body with a resealable septum and outlet made of metal, plastic, or combination of these materials and a long-term intravascular catheter is either preattached to the port or attached to the port at the time of device placement. The device is available in various profiles and sizes and can be of a single or multiple lumen design.

• Incus and Stapes Ossicular Prosthesis