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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• EMG Cables

• EMG Electrodes

• EMG Electrodes

• Endometrial Biopsy Kit

• Endoscopic Nasal Jejunal Feeding Tube

• Endoscopic Smoke Removal Tube (FDA Code: FCZ / 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.

• ENT Device Components, Spare Parts

• Enteral Feeding Bag

• Enteral Feeding Bags with Pre-attached Delivery Sets

• Enteral Feeding Tubes

• Epicardial Lead Placement Tools

• Feeding Tube Accessories

• Feeding Tubes (FDA Code: FPD / 876.5980) A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).

• Female Urethral Catheterization Kit

• Fiberoptic Surgical Light (FDA Code: FST / 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.

• Flexible Fabric Adhesive Bandages

• Flow Control Valves

• Foley Catheter Introducer

• Forceps (FDA Code: HTD / 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.

• Future Ring and Band Systems

• Gastric Access Feeding Tubes

• Gastrostomy Feeding Tubes

• General & Plastic Surgery Ventricular Catheter (FDA Code: GBS / 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.

• 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.

• Head Cap For MRI

• Heart Lung Machine

• Heart Positioners

• 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)

• Humidification, Temperature Probes

• Implantable Cardioverter Defibrillators

• 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 Loop Recorders (14 month recording)

• Implantable Loop Recorders (42 minutes of memory)

• 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.

• Implantable Venous Access Catheter Introducer Kits

• Implantable, Silicone - End Caps MC-01

• 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 Sacral Nerve Stimulator

• Infuse Bone Graft & LT-Cage Devices

• 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.

• Interconnection & Adaptors

• Intestinal Stimulator (FDA Code: LNQ)

• Intravascular Catheter Securement Device (FDA Code: KMK / 880.5210) An intravascular catheter securement device is a device with an adhesive backing that is placed over a needle or catheter and is used to keep the hub of the needle or the catheter flat and securely anchored to the skin.

• Jejunal Feeding Tubes

• Jejunostomy Feeding Tube

• Laser Smoke Evacuation System