Accellent Inc.

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Contact: Diane Shay
Web: http://www.accellent.com
E-Mail:
Address: 100 Fordham Road, Wilmington, Massachusetts 01010, USA
Phone: +1-(978)-570-6900/866-899-1392 | Fax: +1-(978)-657-0878 | Map/Directions >>
 
 

Profile: Accellent Inc specializes in providing chain solutions to cardiology, drug delivery, endoscopy, neurology, orthopaedic and general medical fields. We design, develop, manufacture and assemble implants & devices for the cardiac rhythm disease management (CRDM), interventional radiology/cardiology, cardiac surgery and peripheral vascular markets. Our cardiac rhythm disease management service provides pacemakers, implantable cardioverter defibrillators (ICD), cardiac resynchronization therapy devices (CRT-D), pacing, ICD and CRT-D leads, lead delivery systems, electrophysiology catheters and tunneling tool. Our drug delivery system is applied in auto injection systems (needle and needle free), implantable access ports, implantable pump systems, implantable seeds, tubes, catheters & delivery systems, infusion & IV connector systems, cannula based delivery systems and respiratory catheter systems.

The company was founded in 2000, has revenues of USD 10-25 Million, has ~120 employees and is ISO 9003 certified.

FDA Registration Number: 1218882

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• Active Closure Devices
• Anastomosis Device Sizer
• Anoscope and Accessories (FDA Code: FER / 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.
• Arthroscopes (FDA Code: HRX / 888.1100)
An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.
• Arthroscopy Instruments
• Balloon Catheters
• Beating Heart Surgery System
• Biliary Mechanical Lithotriptor (FDA Code: LQC / 876.4500)
A mechanical lithotriptor is a device with steel jaws that is inserted into the urinary bladder through the urethra to grasp and crush bladder stones.
• Biopsy Forceps
• Biopsy Instruments (FDA Code: KNW / 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.
• Biopsy Instruments (FDA Code: KNW / 876.1075)
• Bladder Control Devices
• Breast Biopsy Devices
• Cardiac Resynchronization Therapy Device (Cardiology, Vascular Surgery)
• Diagnostic Biliary Catheter (FDA Code: FGE / 876.5010)
A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.
• Disposable Surgical Instrument (FDA Code: KDC / 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.
• Distal Projection Devices
• Drug Delivery System
• Electrode Recording Catheter (FDA Code: DRF / 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.
• Electrophysiology Catheters
• Electrosurgical Cutting and Coagulation Device (FDA Code: GEI / 878.4400)
An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.
• Embolic Protection Device
• Endoscopic Vessel Harvesting System
• Endoscopy Devices
• Esophageal Pacing System (FDA Code: LPA)
• 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.
• Gastro-Urology Endoscopic Injection Needle (FDA Code: FBK / 876.1500)
• Gastroenterology-Urology Endoscopic Guidewire (FDA Code: OCY / 876.1500)
• Gastrointestinal Tube and Accessories (FDA Code: KNT / 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).
• General & Plastic Surgery Laparoscope (FDA Code: GCJ / 876.1500)
• Grasping Forceps
• Guide Catheters
• Guidewires
• Image-Intensified Fluoroscopic X-Ray System (FDA Code: JAA / 892.1650)
An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
• Implantable Cardioverter Defibrillators
• Inhalation Therapy Systems
• Intraocular Lens Folders and Injectors (FDA Code: MSS / 886.4300)
An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.
• Intraocular Lens Guide (FDA Code: KYB / 886.4300)
• Intravenous Administration Kit (FDA Code: FPA / 880.5440)
An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.
• Kidney Perfusion System (FDA Code: KDN / 876.5880)
An isolated kidney perfusion and transport system and accesssories is a device that is used to support a donated or a cadaver kidney and to maintain the organ in a near-normal physiologic state until it is transplanted into a recipient patient. This generic type of device may include tubing, catheters, connectors, an ice storage or freezing container with or without bag or preservatives, pulsatile or nonpulsatile hypothermic isolated organ perfusion apparatus with or without oxygenator, and disposable perfusion set.
• Mechanical/Hydraulic Incontinence Device (FDA Code: EZY / 876.5280)
An implanted mechanical/hydraulic urinary continence device is a device used to treat urinary incontinence by the application of continuous or intermittent pressure to occlude the urethra. The totally implanted device may consist of a static pressure pad, or a system with a container of radiopaque fluid in the abdomen and a manual pump and valve under the skin surface that is connected by tubing to an adjustable pressure pad or to a cuff around the urethra. The fluid is pumped as needed from the container to inflate the pad or cuff to pass on the urethra.
• Metallic Bone Fixation Suture Anchor (FDA Code: NOV / 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.
• Microcatheter Technology, Thermal Catheters
• Microwave Hyperthermia System (FDA Code: MEQ)
• Neurovascular Guidewires
• Non-Electric Biopsy Forceps (FDA Code: FCL / 876.1075)
• Orthopaedic Screws
• Orthopedic Manual Surgical Instrument (FDA Code: LXH / 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.
• Pacemaker Analyzer
• Phacofragmentation Unit (FDA Code: HQC / 886.4670)
A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.

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