Profile: Advanced Bionics Corporation focuses on the development of implantable, high-technology neuro stimulation devices. We concentrate in the manufacture of cochlear implant technology (restores hearing to the deaf). We also create other bionic devices for a variety of neurological conditions, including chronic pain and hearing loss. HarmonyT hi resolutionr Bionic ear system to help cochlear implant recipients maximize their hearing potential beyond words and to experience as much of the full spectrum of natural sound and life as possible. The new harmony system comprised of revolutionary hi resolution sound processing, the new HiRes fidelity 120T programming option, the new harmony sound processor, the platinum seriesT sound processor, and the HiRes 90Kr Implant enhances music appreciation and improves hearing performance in a variety of difficult listening environments.

FDA Registration Number: 3006556115

51 to 100 of 139 Products/Services (Click for related suppliers)  Page: 1 [2] 3

• Endoscope Accessories (FDA Code: KOG)

• Endoscopic Cytology Brush (FDA Code: FDX / 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.

• Endoscopic Electrosurgical Unit and Accessories (FDA Code: KNS / 876.4300) An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.

• ENT Educational Materials

• Esophageal Dilators (FDA Code: KNQ / 876.5365) An esophageal dilator is a device that consists of a cylindrical instrument that may be hollow and weighted with mercury or a metal olive-shaped weight that slides on a guide, such as a string or wire and is used to dilate a stricture of the esophagus. This generic type of device includes esophageal or gastrointestinal bougies and the esophageal dilator (metal olive).

• Esophageal Ligator (FDA Code: MND / 876.4400) A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid.

• Esophageal Prosthesis (FDA Code: ESW / 878.3610) An esophageal prosthesis is a rigid, flexible, or expandable tubular device made of a plastic, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the esophagus. The metal esophageal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.

• Esterase (FDA Code: JCH / 864.1850) Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.

• Expandable Metalic Colonic Stent (FDA Code: MQR / 878.3610)

• Expandable Tracheal Prosthesis (FDA Code: JCT / 878.3720) The tracheal prosthesis is a rigid, flexible, or expandable tubular device made of a silicone, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the trachea or trachealbronchial tree. It may be unbranched or contain one or two branches. The metal tracheal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.

• 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).

• Flexible Snare (FDA Code: FDI / 876.4300)

• Flexible Stone Dislodger (FDA Code: FGO / 876.4680) A ureteral stone dislodger is a device that consists of a bougie or a catheter with an expandable wire basket near the tip, a special flexible tip, or other special construction. It is inserted through a cystoscope and used to entrap and remove stones from the ureter. This generic type of device includes the metal basket and the flexible ureteral stone dislodger.

• Flexible/Rigid Bronchoscope (FDA Code: EOQ / 874.4680) A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.

• Fluid Evacuator System (FDA Code: FHF / 876.4370) A gastroenterology-urology evacuator is a device used to remove debris and fluids during gastroenterological and urological procedures by drainage, aspiration, or irrigation. This generic type of device includes the fluid evacuator system, manually powered bladder evacuator, and the AC-powered vacuum pump.

• Gastro-Enterostomy Tube (FDA Code: KGC / 876.5980)

• Gastro-Urology Evacuator (FDA Code: KQT / 876.4370)

• Gastro-Urology Needle (FDA Code: FHR / 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.

• Gastro-Urology Stylet (FDA Code: EZB / 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).

• Gastro-Urology Ureteral Catheter (FDA Code: EYB / 876.5130)

• Gastroenterologic Needle Holder (FDA Code: FHQ / 876.4730) A manual gastroenterology-urology surgical instrument and accessories is a device designed to be used for gastroenterological and urological surgical procedures. The device may be nonpowered, hand-held, or hand-manipulated. Manual gastroenterology-urology surgical instruments include the biopsy forceps cover, biopsy tray without biopsy instruments, line clamp, nonpowered rectal probe, nonelectrical clamp, colostomy spur-crushers, locking device for intestinal clamp, needle holder, gastro-urology hook, gastro-urology probe and director, nonself-retaining retractor, laparotomy rings, nonelectrical snare, rectal specula, bladder neck spreader, self-retaining retractor, and scoop.

• Gastrointestinal Tube and Accessories (FDA Code: KNT / 876.5980)

• General & Plastic Surgery Biopsy Brush (FDA Code: GEE / 878.4800)

• General & Plastic Surgery Laparoscope (FDA Code: GCJ / 876.1500)

• General & Plastic Surgery Nephrostomy Catheter (FDA Code: GBO / 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.

• General Surgical Manual Instrument (FDA Code: MDM / 878.4800)

• 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.

• Hearing Aid Batteries and Accessories

• Hearing Battery Accessories

• High-Density Array Intracardiac Mapping Catheter (FDA Code: MTD / 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.

• Hysteroscope and Accessories (FDA Code: HIH / 884.1690) A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.

• Instrument Surgical Guide (FDA Code: FZX / 878.4800)

• Intracranial Neurovascular Stent (FDA Code: NJE)

• Intravascular Ultrasound Catheter (FDA Code: OBJ / 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.

• Irrigation Catheter (FDA Code: GBX / 878.4200)

• Lead (Dedicated Instruments) Fluorometer (FDA Code: DOX / 862.3550) A lead test system is a device intended to measure lead, a heavy metal, in blood and urine. Measurements obtained by this device are used in the diagnosis and treatment of lead poisoning.

• Ligature Passing and Knot Tying Instrument (FDA Code: HCF / 878.4800)

• Magnetic Stimulators

• Manual Gastro-Urology Surgical Instrument (FDA Code: KOA / 876.4730)

• Manually Operated Bladder Evacuator (FDA Code: FFD / 876.4370)

• Metal Ureteral Basket Stone Dislodger (FDA Code: FFL / 876.4680)

• Microwave Hyperthermia System (FDA Code: MEQ)

• Miscellaneous Endoscope Bulb Adaptor (FDA Code: FFY / 876.1500)

• Nephrostomy Catheter (FDA Code: LJE)

• Neurovascular Embolization Device (FDA Code: HCG / 882.5950)

• Non Dental Irrigating Syringe (FDA Code: KYZ / 880.6960) An irrigating syringe is a device intended for medical purposes that consists of a bulb or a piston syringe with an integral or a detachable tube. The device is used to irrigate, withdraw fluid from, or instill fluid into, a body cavity or wound.

• Non Rigid Bronchoscope Biopsy Brush (FDA Code: BTG / 874.4680)

• Non-Electric Biopsy Forceps (FDA Code: FCL / 876.1075) A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

• Non-Invasive Magnetic Stimulators

• Percutaneous Catheter (FDA Code: DQY / 870.1250) A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.