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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• Continuous Intracranial Pressure Monitor (FDA Code: GWM / 882.1620) An intracranial pressure monitoring device is a device used for short-term monitoring and recording of intracranial pressures and pressure trends. The device includes the transducer, monitor, and interconnecting hardware.

• Corkscrew (FDA Code: HWI / 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.

• Corneo-Scleral Punch (FDA Code: HNJ / 886.4350) A manual ophthalmic surgical instrument is a nonpowered, handheld device intended to aid or perform ophthalmic surgical procedures. This generic type of device includes the manual corneal burr, ophthalmic caliper, ophthalmic cannula, eyelid clamp, ophthalmic muscle clamp, iris retractor clip, orbital compressor, ophthalmic curette, cystotome, orbital depressor, lachrymal dilator, erisophake, expressor, ophthalmic forcep, ophthalmic hook, sphere introducer, ophthalmic knife, ophthalmic suturing needle, lachrymal probe, trabeculotomy probe, cornea-sclera punch, ophthalmic retractor, ophthalmic ring (Flieringa), lachrymal sac rongeur, ophthalmic scissors, enucleating snare, ophthalmic spatula, ophthalmic specula, ophthalmic spoon, ophthalmic spud, trabeculotome or ophthalmic manual trephine.

• Coronary Drug-Eluting Stent (FDA Code: NIQ)

• Coronary Stent (FDA Code: MAF)

• Cosmetic Microsurgical Instruments

• Cosmetic Pharmaceuticals, Wound Dressings

• Cosmetic Surgery Instruments

• Countersink (FDA Code: HWW / 888.4540)

• Curettes (FDA Code: HTF / 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.

• Cystotome (FDA Code: HNY / 886.4350)

• Depth Gauge (FDA Code: HTJ / 888.4300) A depth gauge for clinical use is a measuring device intended for various medical purposes, such as to determine the proper length of screws for fastening the ends of a fractured bone.

• Diagnostic Biliary Catheter (FDA Code: FGE / 876.5010) A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.

• Diagnostic Electromyograph (FDA Code: IKN / 890.1375) A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.

• Diagnostic Electromyograph Needle Electrode (FDA Code: IKT / 890.1385) A diagnostic electromyograph needle electrode is a monopolar or bipolar needle intended to be inserted into muscle or nerve tissue to sense bioelectrical signals. The device is intended for medical purposes for use in connection with electromyography (recording the intrinsic electrical properties of skeletal muscle).

• Diagnostic Intravascular Catheter (FDA Code: DQO / 870.1200) An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

• Diagnostic Trans-Nasal Esophagoscope

• Diagnostic Ultrasonic Transducer (FDA Code: ITX / 892.1570) A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.

• Diluting Pipette (FDA Code: GGY / 864.6160) A manual blood cell counting device is a device used to count red blood cells, white blood cells, or blood platelets.

• Disposable Aspiration and Injection Needle (FDA Code: GAA / 878.4800)

• Drill Bit (FDA Code: HTW / 888.4540)

• Drill Brace (FDA Code: HXY / 888.4540)

• Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode (FDA Code: OJX)

• Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes (FDA Code: NVN)

• Drug-Eluting Permanent Defibrillator Electrodes (FDA Code: NVY)

• Dual Chamber Implantable Pulse-Generator (FDA Code: LWP)

• Dura-Substitute (FDA Code: GXQ / 882.5910) A dura substitute is a sheet or material that is used to repair the dura mater (the membrane surrounding the brain).

• Ear Cannula (FDA Code: JYC / 878.4800)

• Ear Curette (FDA Code: JYG / 874.4420)

• Ear Excavator (FDA Code: JYH / 874.4420)

• Ear Knife (FDA Code: JYO / 874.4420)

• Ear Rasp (FDA Code: JYY / 874.4420)

• Ear Scissors (FDA Code: JZB / 874.4420)

• Ear Snare (FDA Code: JZD / 874.4420)

• Ear Speculum (FDA Code: EPY / 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.

• Ear Speculum Holder (FDA Code: JYK / 878.1800)

• Ear Spoon (FDA Code: JZE / 874.4420)

• Ear Suction Tube (FDA Code: JZF / 874.4420)

• Ear Wick (FDA Code: KCN / 874.5220) An ear, nose, and throat drug administration device is one of a group of ear, nose, and throat devices intended specifically to administer medicinal substances to treat ear, nose, and throat disorders. These instruments include the powder blower, dropper, ear wick, manual nebulizer pump, and nasal inhaler.

• Electric Drill Motor (FDA Code: HBC / 882.4360) An electric cranial drill motor is an electrically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.

• Electric ENT Surgical Drill (FDA Code: ERL / 874.4250) An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.

• Electrical Nerve Stimulators

• Electrocardiograph (FDA Code: DPS / 870.2340) An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.

• Electrocardiograph Transmitter/Receiver System (FDA Code: DXH / 870.2920) A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.

• Electrode Recording Catheter (FDA Code: DRF / 870.1220) An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.

• Electrosurgical Apparatus (FDA Code: HAM / 878.4400) An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

• Electrosurgical Cutting and Coagulation Device (FDA Code: GEI / 878.4400)

• Embolectomy Catheters (FDA Code: DXE / 870.5150) An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.

• Endolymphatic Shunt Tube (FDA Code: ESZ / 874.3820) An endolymphatic shunt is a device that consists of a tube or sheet intended to be implanted to relieve the symptons of vertigo. The device permits the unrestricted flow of excess endolymph from the distended end of the endolymphatic system into the mastoid cavity where resorption occurs. This device is made of polytetrafluoroethylene or silicone elastomer.

• Endoscope Accessories (FDA Code: KOG)