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
• Indirect Pacemaker Generator Function Analyzer (FDA Code: KRE / 870.3640) An indirect pacemaker generator function analyzer is an electrically powered device that is used to determine pacemaker function or pacemaker battery function by periodically monitoring an implanted pacemaker's pulse rate and pulse width. The device is noninvasive, and it detects pacemaker pulse rate and width via external electrodes in contact with the patient's skin. |
• Infant Tongue Depressor (FDA Code: FMA / 880.6230) A tongue depressor is a device intended to displace the tongue to facilitate examination of the surrounding organs and tissues. |
• Inferior Turbinate Blade |
• Infusion Stand (FDA Code: FOX / 880.6990) The infusion stand is a stationary or movable stand intended to hold infusion liquids, infusion accessories, and other medical devices. |
• Instrument Surgical Guide (FDA Code: FZX / 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. |
• Insulin Infusion Pump (FDA Code: LZG / 880.5725) An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm. |
• Internal Gauze/Sponge (FDA Code: EFQ) |
• Internal Nasal Splints |
• Intervertebral Disc Prosthesis (FDA Code: MJO) |
• Intestinal Stimulator (FDA Code: LNQ) |
• Intranasal Septal Splint (FDA Code: LYA / 874.4780) An intranasal splint is intended to minimize bleeding and edema and to prevent adhesions between the septum and the nasal cavity. It is placed in the nasal cavity after surgery or trauma. The intranasal splint is constructed from plastic, silicone, or absorbent material. |
• Intraventricular Subcutaneous Implanted Port & Catheter (FDA Code: LKG / 882.5550) |
• Invasive Glucose Sensor (FDA Code: MDS) |
• Irrigation Catheter (FDA Code: GBX / 878.4200) An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles. |
• Junior Tongue Depressor (FDA Code: FMA / 880.6230) |
• Lacrimal Dilator (FDA Code: HNW / 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. |
• Lacrimal Probes (FDA Code: HNL / 886.4350) |
• Lacrimal Sac Rongeur (FDA Code: HNG / 886.4350) |
• Laparoscopic Probes |
• Laryngeal Injection Kit (FDA Code: KAA / 874.4420) |
• Laryngeal Knife (FDA Code: JZY / 874.4420) |
• Laryngeal Trocar (FDA Code: KAB / 874.4420) |
• Laser Power Probe |
• Ligature Carrier (FDA Code: GEJ / 878.4800) |
• Ligature Carrier Set (FDA Code: GEJ / 878.4800) |
• Ligature Passing and Knot Tying Instrument (FDA Code: HCF / 878.4800) |
• Limb Brace Orthosis (FDA Code: IQI / 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. |
• Lipoplasty Suction System (FDA Code: MUU / 878.5040) A suction lipoplasty system is a device intended for aesthetic body contouring. The device consists of a powered suction pump (containing a microbial filter on the exhaust and a microbial in-line filter in the connecting tubing between the collection bottle and the safety trap), collection bottle, cannula, and connecting tube. The microbial filters, tubing, collection bottle, and cannula must be capable of being changed between patients. The powered suction pump has a motor with a minimum of 1/3 horsepower, a variable vacuum range from 0 to 29.9 inches of mercury, vacuum control valves to regulate the vacuum with accompanying vacuum gauges, a single or double rotary vane (with or without oil), a single or double diaphragm, a single or double piston, and a safety trap. |
• Liquid Medication Dispenser (FDA Code: KYX / 880.6430) A Liquid medication dispenser is a device intended for medical purposes that is used to issue a measured amount of liquid medication. |
• Low-Pressure Pulse Generator |
• Lumbar Intervertebral Fusion Device with Bone Graft (FDA Code: MAX / 888.3080) |
• Lumbar Solid-Sphere Intervertebral Fusion Device With Bone Graft (FDA Code: NVR) |
• Lumbosacral Orthosis (FDA Code: IPY / 890.3490) A truncal orthosis is a device intended for medical purposes to support or to immobilize fractures, strains, or sprains of the neck or trunk of the body. Examples of truncal orthoses are the following: Abdominal, cervical, cervical-thoracic, lumbar, lumbo-sacral, rib fracture, sacroiliac, and thoracic orthoses and clavicle splints. |
• Manual Dermabrasion Brush (FDA Code: GED / 878.4800) |
• Manual Osteotome (FDA Code: GFI / 878.4800) |
• Manual Saw & Accessories (FDA Code: GDR / 878.4800) |
• Manual Surgical Chisel (FDA Code: FZO / 878.4800) |
• Manual Trephines & Accessories (FDA Code: HBG / 882.4300) Manual cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments that are used without a power source on a patient's skull. |
• Mastoid Chisel (FDA Code: JYD / 878.4800) |
• Mastoid Gauge (FDA Code: JYI / 874.4420) |
• Mastoid Rongeurs (FDA Code: JZA / 874.4420) |
• Mastoid Searcher (FDA Code: JZC / 874.4420) |
• Measuring Ear Rod (FDA Code: JYZ / 874.4420) |
• Mechanical Heart Valve (FDA Code: LWQ) |
• Medical Probes (FDA Code: HXB / 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. |
• Medical Rasps (FDA Code: HTR / 878.4800) |
• Metal Laminoplasty Plate Spine Orthosis (FDA Code: NQW / 888.3050) A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome. |
• Metal Mesh (FDA Code: EZX / 878.3300) Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery. |
• Microdebrider |
• Microsurgical Ear Hook (FDA Code: JYL / 874.4420) |