BEUDAMED
    36 results · 13ms · Sources: EU EUDAMED, US FDA

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    Continuous Nerve Block Needle; Product Codes: AB-00090, AB-00150, AB-17040-N, AB-17080-N, AB-17110-N, AB-17140-N, AB-18080-N, AB-18110-N

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·June 6, 2018

    The GSP 2021-0010 (Genetic Screening Processor) instrument is a fully automated, high through put batch analyzer for time- resolved and prompt fluorescence analysis of samples in microtitration plates. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids. The chemistries running on the GSP instrument are used to test blood specimens dried on filter paper as an aid in screening newborns for congenital disorders.

    FDA Recall
    Terminated ·PerkinElmer LAS, Inc·Product code JLW·October 24, 2011

    BIOPLEX 2200 EBV IgG KIT, CALIBRATORS, AND CONTROLS: 100 tests - Catalog No. 665-1250 - manufactured by Bio-Rad Laboratories in Redmond, WA 98052. The product is multiflow immunoassay intended for the quantitative detection of IgG antibodies to three (3) seperate EBV antigens in human serum. They are: 1) Epstein-Barr Virus Nuclear Antigen-1 (EBV-NA-1); 2) Viral Capsid Antigen (EBV VCA); and 3) Early Antigen diffuse (EBV EA-D).

    FDA Recall
    Terminated ·Bio-Rad Laboratories·Product code LSE·November 13, 2007

    a translucent, rectangular, resorbable, collagen membrane sheet derived from bovine tissue. Colla Guide Collagen Membrane Distributed by: Riemser Inc., PO Box 12339 Research Triangle Park, NC 27709-2339 USA Kensey Nash Corporation, 735 Pennsylvania Drive, Exton, PA 19341 USA QTY 1 Sterile Rx only 20mm X 30mm REF 20650-02 6280-02 Rev.AE Quantity 1 STERILE EO Sterilized using ethylene oxide Do not store product above 30C (86F) Do not re-use. CollaGuide Collagen Dental Membrane is indicated for simultaneous use of guided bone regeneration (GBR)-membrane and implants, augmentation around implants placed in immediate extraction sites, augmentation around implants placed in delayed extraction sockets, localized ridge augmentation for later implantation, alveolar ridge reconstruction for prosthetic treatment, filling of bone defects after root resection, cystectomy, removal of retained teeth, guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.

    FDA Recall
    Terminated ·Kensey Nash Corp·Product code NPL·February 28, 2012

    TriActiv FX Embolic Protection System 7F, Catalog numbers 60040-02 (has 190 cm guidewire) and 60040-03 (has 300 cm guidewire). The devices are comprised of four principal components including the ShieldWire Balloon Guidewire, the Shieldwire Inflator, the FX or LFX Catheter, and the AutoStream Flow Control.

    FDA Recall
    Terminated ·Kensey Nash Corp·Product code FRO·March 28, 2007

    FX Spare Shieldwire Inflators (3.0 - 5.0 mm), Catalog number 60042-02. The product is sold 5 per box.

    FDA Recall
    Terminated ·Kensey Nash Corp·Product code FRO·March 28, 2007

    TriActiv System Procedure Kit. Balloon Protected Flush Extraction System 190 cm (for embolism protection). The kit includes AutoStream Flow Control, Flush Kit, ShieldWire (temporary occlusion balloon guidewire), and Balloon Inflation Syringe). The system is used with a standard 7F guide catheter using the standard femoral approach.

    FDA Recall
    Terminated ·Kensey Nash Corp·Product code NFA·May 24, 2006

    TriActiv System Balloon Inflation Syringe. The syringe packs/boxes contain 5 'spare' syringes.

    FDA Recall
    Terminated ·Kensey Nash Corp·Product code NFA·May 24, 2006

    TriActiv System Procedure Kit. Balloon Protected Flush Extraction System 340 cm (for embolism protection). The kit includes AutoStream Flow Control, Flush Kit, ShieldWire (temporary occlusion balloon guidewire), and Balloon Inflation Syringe). The system is used with a standard 7F guide catheter using femoral approach.

    FDA Recall
    Terminated ·Kensey Nash Corp·Product code NFA·May 24, 2006

    a translucent, rectangular, resorbable, collagen membrane sheet derived from bovine tissue. Colla Guide Collagen Membrane Distributed by: Riemser Inc., PO Box 12339 Research Triangle Park, NC 27709-2339 USA Kensey Nash Corporation, 735 Pennsylvania Drive, Exton, PA 19341 USA QTY 1 Sterile Rx only 15mm X 20mm Quantity 1 STERILE EO Sterilized using ethylene oxide Do not store product above 30C (86F) Do not re-use. CollaGuide Collagen Dental Membrane is indicated for simultaneous use of guided bone regeneration (GBR)-membrane and implants, augmentation around implants placed in immediate extraction sites, augmentation around implants placed in delayed extraction sockets, localized ridge augmentation for later implantation, alveolar ridge reconstruction for prosthetic treatment, filling of bone defects after root resection, cystectomy, removal of retained teeth, guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.

    FDA Recall
    Terminated ·Kensey Nash Corp·Product code NPL·February 28, 2012

    ProGuard Spare Shieldwire Inflators (2.5 - 5.0 mm), Catalog number 61030-01. The product is sold 5 per box.

    FDA Recall
    Terminated ·Kensey Nash Corp·Product code FRO·March 28, 2007

    TriActiv ProGuard Embolic Protection System, Part number 61000-01. The product is shipped as a procedure kit. It is used with a standard 6F guide catheter using the standard femoral approach.

    FDA Recall
    Terminated ·Kensey Nash Corp·Product code NFA·April 6, 2006

    ThromCat Thrombectomy Catheter System. 7F 2.5 -7.0 mm 150 cm. Catalogue number 63000-01. It is a single-use, disposable device that is used to perform percutaneous maceration and removal of thrombus and restoration of blood flow.

    FDA Recall
    Terminated ·Kensey Nash Corp·Product code MCW·February 7, 2007

    ThromCat Thrombectomy Catheter System. Catalog number 63000-01

    FDA Recall
    Terminated ·Kensey Nash Corp·Product code MCW·May 21, 2007

    a translucent, rectangular, resorbable, collagen membrane sheet derived from bovine tissue. Colla Guide Collagen Membrane Distributed by: Riemser Inc., PO Box 12339 Research Triangle Park, NC 27709-2339 USA Kensey Nash Corporation, 735 Pennsylvania Drive, Exton, PA 19341 USA QTY 1 Sterile Rx only 30mm X 40mm REF 20650-03 6280-03 Rev.AE Quantity 1 STERILE EO Sterilized using ethylene oxide Do not store product above 30C (86F) Do not re-use. CollaGuide Collagen Dental Membrane is indicated for simultaneous use of guided bone regeneration (GBR)-membrane and implants, augmentation around implants placed in immediate extraction sites, augmentation around implants placed in delayed extraction sockets, localized ridge augmentation for later implantation, alveolar ridge reconstruction for prosthetic treatment, filling of bone defects after root resection, cystectomy, removal of retained teeth, guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.

    FDA Recall
    Terminated ·Kensey Nash Corp·Product code NPL·February 28, 2012

    Infant Heel Warmer with Attachment Tab, Nonsterile, Active Product SKU MH00002T The infant heel warmer is activated at the point of care by squeezing the pouch. This mixes the substrates inside the pouch causing an exothermic chemical reaction, warming the pouch, which is then applied to the heel of an infant to aid in blood draws

    FDA Recall
    Terminated ·Cardinal Health·Product code MPO·June 9, 2021

    Infant Heel Warmer without Attachment Tab, Nonsterile, Active Product SKU MH00002N The infant heel warmer is activated at the point of care by squeezing the pouch. This mixes the substrates inside the pouch causing an exothermic chemical reaction, warming the pouch, which is then applied to the heel of an infant to aid in blood draws

    FDA Recall
    Terminated ·Cardinal Health·Product code MPO·June 9, 2021

    X-Guide Surgical Navigation System, X-Clip Bulk Kit The X-Guide Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and the intra-operative surgical phase of dental implantation procedures.

    FDA Recall
    Terminated ·X-NAV Technologies, LLC·Product code PLV·February 23, 2016

    X-Guide Surgical Navigation System, X-Clip Bulk Kit The X-Guide Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and the intra-operative surgical phase of dental implantation procedures.

    FDA Enforcement
    Class II ·Terminated·X-NAV Technologies, LLC·April 20, 2016

    Lactate Gen.2, Catalog Nos. 03183700190, 05171881190, 11822837190, ***added as of 5/10/19*** 03183700190 Product Usage: An In vitro diagnostic reagent system intended for use on cobas Integra for the quantitative determination of the lactate concentration in plasma and cerebrospinal fluid.

    FDA Recall
    Terminated ·Roche Diagnostics Corporation·Product code KHP·December 17, 2018