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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• Bone Rasps (FDA Code: HTR / 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.

• Bone Skid (FDA Code: HWO / 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.

• Bone Taps (FDA Code: HWX / 888.4540)

• Bone Trephine (FDA Code: HWK / 888.4540)

• Burr

• Burr Hole Cover (FDA Code: GXR / 882.5250) A burr hole cover is a plastic or metal device used to cover or plug holes drilled into the skull during surgery and to reattach cranial bone removed during surgery.

• Cables (FDA Code: ISN / 890.3420) An external limb prosthetic component is a device intended for medical purposes that, when put together with other appropriate components, constitutes a total prosthesis. Examples of external limb prosthetic components include the following: Ankle, foot, hip, knee, and socket components; mechanical or powered hand, hook, wrist unit, elbow joint, and shoulder joint components; and cable and prosthesis suction valves.

• Calcium Compound Bone Void Filler (FDA Code: MQV / 888.3045) A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.

• Calipers (FDA Code: KTZ / 888.4150) A caliper for clinical use is a compass-like device intended for use in measuring the thickness or diameter of a part of the body or the distance between two body surfaces, such as for measuring an excised skeletal specimen to determine the proper replacement size of a prosthesis.

• Cardiac Ablation Percutaneous Catheter (FDA Code: LPB)

• Cardiopulmonary Bypass Accessories (FDA Code: KRI / 870.4200) Cardiopulmonary bypass accessory equipment is a device that has no contact with blood and that is used in the cardiopulmonary bypass circuit to support, adjoin, or connect components, or to aid in the setup of the extracorporeal line, e.g., an oxygenator mounting bracket or system-priming equipment.

• Cardiopulmonary Bypass Adaptor (FDA Code: DTL / 870.4290) A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.

• Cardiopulmonary Bypass Blood Reservoir (FDA Code: DTN / 870.4400) A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.

• Cardiopulmonary Bypass Cardiotomy Return Sucker (FDA Code: DTS / 870.4420) A cardiopulmonary bypass cardiotomy return sucker is a device that consists of tubing, a connector, and a probe or tip that is used to remove blood from the chest or heart during cardiopulmonary bypass surgery.

• Cardiopulmonary Bypass Coronary Pressure Gauge (FDA Code: DXS / 870.4310) A cardiopulmonary bypass coronary pressure gauge is a device used in cardiopulmonary bypass surgery to measure the pressure of the blood perfusing the coronary arteries.

• Cardiopulmonary Bypass Defoamer (FDA Code: DTP / 870.4230) A cardiopulmonary bypass defoamer is a device used in conjunction with an oxygenator during cardiopulmonary bypass surgery to remove gas bubbles from the blood.

• Cardiopulmonary Bypass Heat Exchanger (FDA Code: DTR / 870.4240) A cardiopulmonary bypass heat exchanger is a device, consisting of a heat exchange system used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device.

• Cardiopulmonary Bypass In-Line Blood Gas Sensor (FDA Code: DTY / 870.4410) A cardiopulmonary bypass in-line blood gas sensor is a transducer that measures the level of gases in the blood.

• Cardiopulmonary Bypass On-Line Blood Gas Monitor (FDA Code: DRY / 870.4330) A cardiopulmonary bypass on-line blood gas monitor is a device used in conjunction with a blood gas sensor to measure the level of gases in the blood.

• Cardiopulmonary Bypass Oxygenator (FDA Code: DTZ / 870.4350) A cardiopulmonary bypass oxygenator is a device used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery.

• Cardiopulmonary Bypass Pump Speed Controller (FDA Code: DWA / 870.4380) A cardiopulmonary bypass pump speed control is a device used that incorporates an electrical system or a mechanical system, or both, and is used to control the speed of blood pumps used in cardiopulmonary bypass surgery.

• Cardiopulmonary Bypass Pump Tube (FDA Code: DWE / 870.4390) A cardiopulmonary bypass pump tubing is polymeric tubing which is used in the blood pump head and which is cyclically compressed by the pump to cause the blood to flow through the cardiopulmonary bypass circuit.

• Cardiopulmonary Bypass Vascular Catheter (FDA Code: DWF / 870.4210) A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.

• Cardiovascular Surgical Instrument (FDA Code: DWS / 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.

• Cardiovascular Surgical Saw Blade (FDA Code: DWH / 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.

• Cardiovascular Trocar (FDA Code: DRC / 870.1390) A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula.

• Carotid Stent (FDA Code: NIM)

• Carotid Stent Systems (FDA Code: NIM)

• Carrier Surgical Light (FDA Code: FSZ / 878.4580) A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.

• Cast Shoe (FDA Code: IPG / 890.3025) A prosthetic and orthotic accessory is a device intended for medical purposes to support, protect, or aid in the use of a cast, orthosis (brace), or prosthesis. Examples of prosthetic and orthotic accessories include the following: A pelvic support band and belt, a cast shoe, a cast bandage, a limb cover, a prosthesis alignment device, a postsurgical pylon, a transverse rotator, and a temporary training splint.

• Catheter Introducers (FDA Code: DYB / 870.1340) A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

• Catheter Stylets (FDA Code: DRB / 870.1380) A catheter stylet is a wire that is run through a catheter or cannula to render it stiff.

• Catheter Tip Occluder (FDA Code: DQT / 870.1370) A catheter tip occluder is a device that is inserted into certain catheters to prevent flow through one or more orifices.

• Cauterette, Disposable Switch-a-Tip

• Cement Dispenser (FDA Code: KIH / 888.4200) A cement dispenser is a nonpowered syringe-like device intended for use in placing bone cement (888.3027) into surgical sites.

• Cement Mixing Equipment (FDA Code: JDZ / 888.4210) A cement mixer for clinical use is a device consisting of a container intended for use in mixing bone cement (888.3027).

• Cement Obturator (FDA Code: LZN / 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.

• Cement Restrictor Hip Prosthesis (FDA Code: JDK / 878.3300)

• Cemented Metal/Polymer Semi-Constrained Hip Prosthesis (FDA Code: JDI / 888.3350) A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (888.3027).

• Central Nervous System and Components (FDA Code: JXG / 882.5550) A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.

• Cervical Intervertebral Fusion Device With Bone Graft (FDA Code: ODP / 888.3080)

• Cervical Orthosis (FDA Code: IQK / 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.

• Cervical Pedicle Screw Spinal Fixation Orthosis (FDA Code: NKG)

• Cervical Thoracic Orthosis (FDA Code: IPT / 890.3490)

• Chisel/Osteotome (FDA Code: KDG / 878.4820)

• Clavicle Splint (FDA Code: IQJ / 890.3490)

• Clip Surgical Applier (FDA Code: GDO / 878.4800)

• Compression Instrument (FDA Code: HWN / 888.4540)

• Constant Voltage Nerve Stimulators

• Continuous Electronic Thermometer (FDA Code: FLL / 880.2910) A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.