Profile: Medtronic, Inc. specializes in medical technology, thus providing lifelong solutions for people with chronic pain. We focus on cardiac rhythm disease management (CRDM), spinal & biologics, cardiovascular, neuromodulation, diabetes, and surgical technologies. Our cardiac resynchronization therapy (CRT) devices for heart failure include, Consulta™ CRT defibrillator, Maximo™ CRT defibrillator, Concerto™ CRT defibrillator, Insync Maximo™ CRT defibrillator and Carelink remote monitoring network. CRDM's primary product lines are implantable pacemakers, implantable cardioverter-defibrillators (ICDs), implantable cardiac resynchronization therapy devices and monitoring systems. Our latest ICDs include a feature called OptiVol fluid monitoring, which allows physicians to continually track their patient's fluid status using intrathoracic impedance (changes in the fluid flow). It provides trending data so that physicians can adjust medical treatment for patients at risk of acute decompensated heart failure. We also provide a unique, insertable diagnostic monitor for implantable pacemakers that can help physicians determine if unexplained fainting may be the result of an abnormally slow heart rhythm.

The company was founded in 1976, has revenues of USD 1-5 Million, has ~50 employees and is CE certified.

FDA Registration Number: 2182208

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• Product Development, Micro pH Electrodes

• Programmable Diagnostic Computer (FDA Code: DQK / 870.1425) A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.

• Programmable Implantable Heart Pacemaker (FDA Code: DXY / 870.3610) An implantable pacemaker pulse generator is a device that has a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. This device is used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders. This device includes triggered, inhibited, and asynchronous devices implanted in the human body.

• Protamine Sulphate (FDA Code: GFT / 864.7525) A heparin assay is a device used to determine the level of the anticoagulant heparin in the patient's circulation. These assays are quantitative clotting time procedures using the effect of heparin on activated coagulation factor X (Stuart factor) or procedures based on the neutralization of heparin by protamine sulfate (a protein that neutralizes heparin).

• Proximal Femoral Fixation Implant Device (FDA Code: JDO / 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.

• Real-Time Insulin Pump & Continuous Glucose Monitoring Systems

• Rectal Temperature Probes

• Red Rubber Urethral Catheter

• Reservoir Bag (FDA Code: BTC / 868.5320) A reservoir bag is a device, usually made of conductive rubber, intended for use in a breathing circuit as a reservoir for breathing gas and to assist, control, or monitor a patient's ventilation.

• Reusable Temperature Probes

• Reveal Insertable Cardiac Monitors

• RF Therapy Systems

• Ring and Band Systems

• Roller Type Cardiopulmonary Bypass Blood Pump (FDA Code: DWB / 870.4370) A roller-type cardiopulmonary bypass blood pump is a device that uses a revolving roller mechanism to pump the blood through the cardiopulmonary bypass circuit during bypass surgery.

• Sensors For Polysomnography

• Septostomy Catheter (FDA Code: DXF / 870.5175) A septostomy catheter is a special balloon catheter that is used to create or enlarge the atrial septal defect found in the heart of certain infants.

• Single Fiber EMG Software

• Skin Temperature Probes

• Small Pediatric Urethral Catheters

• Spikeable Enteral Feeding Bag

• Spinal Intervertebral Body Fixation Appliance (FDA Code: KWQ / 888.3060) A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct "sway back," scoliosis (lateral curvature of the spine), or other conditions.

• Stabilization Systems

• Stabilization SystemT

• Standard CRT

• Sterile, Infant Feeding Tubes

• Stomach pH Electrode (FDA Code: FFT / 876.1400) A stomach pH electrode is a device used to measure intragastric and intraesophageal pH (hydrogen ion concentration). The pH electrode is at the end of a flexible lead which may be inserted into the esophagus or stomach through the patient's mouth. The device may include an integral gastrointestinal tube.

• Surgical Hooks

• Surgical Urethral Catheter (FDA Code: GBM / 876.5130) A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudecatheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).

• Temperature Monitor with Probe

• Temperature Probe

• Temporary Myocardial Pacing Lead

• Temporary, Transvenous Pacing Lead System

• Thoracic Stent Grafts

• Tiemann Model Coude Tip Latex Urethral Catheters

• Tissue Replacement Heart Valves

• Tissue Stabilizers

• Totally Implanted Spinal Cord Stimulator for Pain Relief (FDA Code: LGW)

• Transcatheter Delivery System

• Transcatheter Pulmonary Valve

• Universal Wedge Urethral Catheter

• Urethral Catheter Procedure Trays

• Urethral Catheter Tray

• Urethral Catheter Tray - Sterile

• Urethral Catheterization Roll Kit

• Urethral Catheterization Trays

• Urethral Catheters (FDA Code: GBM / 876.5130)

• Urinary Retention Neurosimulators

• Urine Collector and Accessories (FDA Code: KNX / 876.5250) A urine collector and accessories is a device intended to collect urine. The device and accessories consist of tubing, a suitable receptacle, connectors, mechanical supports, and may include a means to prevent the backflow of urine or ascent of infection. The two kinds of urine collectors are:

• Urological Percutaneous Catheters and Sets

• Vascular Hemostasis Device (FDA Code: MGB)