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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• Product Development, Atherectomy Device Drive

• Radiofrequency Lesion Generator (FDA Code: GXD / 882.4400) A radiofrequency lesion generator is a device used to produce lesions in the nervous system or other tissue by the direct application of radiofrequency currents to selected sites.

• Radiofrequency Lesion Probe (FDA Code: GXI / 882.4725) A radiofrequency lesion probe is a device connected to a radiofrequency (RF) lesion generator to deliver the RF energy to the site within the nervous system where a lesion is desired.

• Reconstructive Total Joint Implants for Hip

• Reconstructive Total Joint Implants for Knee

• Reusable Shaver Blades

• Scalpel Blade (FDA Code: GES / 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.

• Self-Expanding Nitinol Stent System

• Shoulder Arthroplasty System

• Smooth Fixation Pin (FDA Code: HTY / 888.3040) A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

• Spinal Implants

• Suture Anchors

• Therapeutic Automated Blood Cell and Plasma Separator (FDA Code: LKN)

• Trauma Implants

• Tubal Occlusion Insert (FDA Code: HHS / 884.5380) A contraceptive tubal occlusion device (TOD) and introducer is a device designed to close a fallopian tube with a mechanical structure, e.g., a band or clip on the outside of the fallopian tube or a plug or valve on the inside. The devices are used to prevent pregnancy.

• Ultrasound Catheter

• Urethral Dilation Balloon Catheters