BEUDAMED
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    Olympus Sterile Optical Laser Fiber, single use and reusable

    FDA Enforcement
    Class II ·Terminated·Quanta System, S.p.A.·June 16, 2021

    AGA Medical Corporation, Amplatzer TorqVue Delivery System 45-degree. REF: 9-1TV10F45/80. Designed to facilitate the introduction of transvenous devices to chambers and coronary vasculature of the heart and for introducing therapeutic devices to a location within the peripheral vasculature.

    FDA Recall
    Terminated ·AGA Medical Corporation·Product code DQY·December 18, 2009

    DeRoyal TOTAL HIP TRACECART, REF 53-1820.14, Rx ONLY, NON-STERILE. Custom surgical kit containing Stryker CBCII Blood Conservation Kit.

    FDA Recall
    Terminated ·DeRoyal Industries Inc·Product code LRO·December 9, 2009

    DeRoyal TOTAL KNEE TRACECART, REF 53-1818.13, Rx ONLY, NON-STERILE. Custom surgical kit containing Stryker CBCII Blood Conservation Kit.

    FDA Recall
    Terminated ·DeRoyal Industries Inc·Product code LRO·December 9, 2009

    Stat (TM) Super-Fine (TM) Pen Needles and Allison Medical, Inc. Sure Comfort Pen Needles with Silicone Tip, for human use with insulin pen injector device to administer insulin subcutaneously.

    FDA Recall
    Terminated ·Stat Medical Devices, Inc.·Product code FMI·May 29, 2009

    Stryker Imaging, Guardian Services Software, Part Number 0240-009-430 with Part Numbers 0240-020-013 and 0240-020-022 (Office PACS Power). Intended use is to act as a medical data backup and disaster recovery plan.

    FDA Recall
    Terminated ·Stryker Imaging·Product code LMB·August 31, 2009

    Abbott i-STAT ACT Kaolin Cartridges. In vitro diagnostic test which uses fresh whole blood to monitor high-dose heparin anticoagulation frequently associated with cardiovascular surgery.

    FDA Recall
    Terminated ·Abbott Point of Care Inc.·Product code JBP·August 18, 2009

    Abbott i-STAT ACT Celite Cartridges. In vitro diagnostic test used to monitor moderate and high-level heparin therapy through analysis of arterial and venous whole blood samples.

    FDA Recall
    Terminated ·Abbott Point of Care Inc.·Product code JBP·August 18, 2009

    Boston Scientific Guider Softip TM XF Guide Catheter Catheter is intended to facilitate the placement of interventional devices into the neurovascular system.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code DQY·December 18, 2009

    Dall Miles Cable Grip System; Catalog number 6704-0-210; Stryker Ireland. The Dall-Miles Recon and Trauma Cable System provides the surgeon with a variety of methods for achieving trochanteric reattachment and for cerclage fixation.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code KTT·June 18, 2009

    Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate, Left, Size 0, TIB B/PL, for cemented use only, sterile, Zimmer, Warsaw, IN; Model Number: 6420-00-200. The Natural-Knee II System Cemented Modular Tibial Baseplate is a nonporous component which may be used in total knee replacement surgery. The baseplate is intended for cemented use only.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code JWH·March 18, 2009

    Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate, Right, Size 0, TIB B/PL, for cemented use only, sterile, Zimmer, Warsaw, IN; Model Number: 6420-01-200. The Natural-Knee II System Cemented Modular Tibial Baseplate is a nonporous component which may be used in total knee replacement surgery. The baseplate is intended for cemented use only.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code JWH·March 18, 2009

    V 40 Femoral Head, Sterile, 22 mm; Catalog number 6260-4-122, Catalog number 6260-5-226; Howmedica Osteonics Corp., Stryker Ireland, Carrigtwohill County Cork, Ireland; Intended for use with femoral stems and acetabular components in primary or revision total hip arthroplasty.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code LWJ·June 18, 2009

    Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate, Left, Size 00, for cemented use only, sterile, Zimmer, Warsaw, IN; Model Number: 6420-00-002. The Natural-Knee II System Cemented Modular Tibial Baseplate is a nonporous component which may be used in total knee replacement surgery. The baseplate is intended for cemented use only.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code JWH·March 18, 2009

    Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate, Right, Size 00, for cemented use only, sterile, Zimmer, Warsaw, IN; Model Number: 6420-01-002. The Natural-Knee II System Cemented Modular Tibial Baseplate is a nonporous component which may be used in total knee replacement surgery. The baseplate is intended for cemented use only.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code JWH·March 18, 2009

    Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN# DESCRIPTION M0064101260 Percutaneous Combination Stent/Nephrostomy Catheter 8 Fr Single Use Only, Sterilized with Ethylene Oxide Gas, Boston Scintific Corporation, One Boscton Scintific Place, Natick, MA 01760-1537, Made in USA 780 Brookside Drive, Spencer, IN 47460 1080. Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code FAD·March 18, 2009

    Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN# DESCRIPTION M001225240 VTC FIRM KIT 8 M001225140 VTC FIRM 8 Single Use Only, Sterilized with Ethylene Oxide Gas, Boston Scintific Corporation, One Boscton Scintific Place, Natick, MA 01760-1537, Made in USA 780 Brookside Drive, Spencer, IN 47460 1080. Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code GBO·March 18, 2009

    Medtronic Physio-Control LIFEPAK CR Plus Defibrillator/Monitor. Automated external defibrillator deployed primarily in public access defibrillator environments where the expected use for any one device is once every 20 months. For use on persons requiring defibrillation therapy.

    FDA Recall
    Terminated ·Physio Control, Inc.·Product code MKJ·July 31, 2009

    Polarus(R) Humeral Fixation System, size: 3.5mm x 25.0mm Cortical Screw, QTY 1, Ref: HCO3250-S Acumed, LLC Hillsboro, OR Intended use: Acumed intramedullary rods and screws are designed to provide fixation of humeral, forearm and fibula fractures while they heal.

    FDA Recall
    Terminated ·Acumed LLC·Product code HWC·May 19, 2009

    Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN# DESCRIPTION M0064101110 Percutaneous Nephrostomy Catheters Percutaneous with Locking Loop 8 Fr M0064101120 Nephrostomy Catheters with Locking Loop 10 Fr Single Use Only, Sterilized with Ethylene Oxide Gas, Boston Scintific Corporation, One Boscton Scintific Place, Natick, MA 01760-1537, Made in USA 780 Brookside Drive, Spencer, IN 47460 1080. Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code FGE·March 18, 2009