BEUDAMED
    88 results · 14ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Terminated ×

    rHead Stem Implant Plasma Coated, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

    FDA Enforcement
    Class II ·Terminated·Howmedica Osteonics Corp.·August 15, 2018

    Extremity Medical - Disposable Orthopedic Surgical Instrument - 1.6 mm Guidewire - Reference Number 101-00006 - Non-Sterile. Contained in Extremity Medical Surgical Kits including CompressX, Hallu.X, IO Fix and XMCP. Used in the selection of screw size when used with appropriate depth gauge.

    FDA Recall
    Terminated ·Extremity Medical LLC·Product code HXI·January 10, 2013

    IMMULITE Systems Third Generation TSH (REF LKTS1 - 100T, LKTS5 - 500T, L2KTS2 - 200T, L2KTS6 - 600T). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code JLW·May 10, 2013

    Dimension TSH Flex Reagent Cartridge (REF RF412). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code JLW·May 10, 2013

    IMMULITE Systems Rapid TSH (REF LKRT1 - 100T, LKRT5 - 500 T, L2KRT2 - 200T, L2KRT6 - 600T). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code JLW·May 10, 2013

    Dimension Vista System TSH Flex Reagent Cartridge (REF K6412). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code JLW·May 10, 2013

    Dimension EXL LOCI Module TSHL Flex Reagent Cartridge (REF RF612). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code JLW·May 10, 2013

    ADVIA Centaur Systems TSH3 Ultra ReadyPack ((REF 06491072 - 100 Tests, REF 06491080 - 500 Tests, REF 04862625 - 2500T). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code JLW·May 10, 2013

    Drill (Fluted-Hard Bone), for Quattro Link 2.9mm, labeled as: a. Quattro Spade Drill, for 2.9mm, Model Number CM-9300; b. Quattro Drill 2.4mm, Hard Bone, Model Number CM-9324

    FDA Recall
    Terminated ·Cayenne Medical Inc.·Product code HTW·October 10, 2013

    BD Microtainer Quikheel Lancet 1.0 mm incision Depth 2.5 mm Incision Length REF 368101 Rx Only Becton, Dickinson and Company, Franklin Lakes, NJ 07417 USA Made in USA. Used to perform heel sticks for the purpose of collecting skin puncture blood.

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code FMK·July 10, 2013

    VariAx Compression Plating System

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code HWC·October 10, 2013

    Bright Embrace, a Single Bili Light for newborn phototherapy Distributed by: Physician Engineered Products, Inc., Model SBL60

    FDA Recall
    Terminated ·Physician Engineered Products, Inc.·Product code LBI·August 31, 2013

    ROSA Surgical Device 2.5.8

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code HAW·February 10, 2013

    Biomet 3i Dental Implant, Parallel Walled 6mm (D) x 10mm (L)

    FDA Recall
    Terminated ·Biomet 3i, LLC·Product code DZE·May 10, 2013

    VERIFY Dual Species Self-Contained Biological Indicator, Distributed by STERIS Corporation, Mentor, OH. Intended for use in installation testing and routine monitoring of steam sterilization and ethylene oxide sterilization processes.

    FDA Recall
    Terminated ·Steris Corporation·Product code FRC·September 10, 2013

    Biomet 3i Dental Implant, Non-Platform Switched Parallel Walled Implant 5mm (D) x 13mm (L)

    FDA Recall
    Terminated ·Biomet 3i, LLC·Product code DZE·May 10, 2013

    E-Z WIDER BARIATRIC CHAIR BED; Single Motion Expandable Width Technology

    FDA Recall
    Terminated ·Kreg Medical Inc.·Product code OSI·August 2, 2012

    AperFix Femoral Implant Coring Removal Drill, labeled as the following: a. Femoral Removal Coring Reamer 9mm, Model Number CM-7109; b. Femoral Removal Coring Reamer 10mm, Model Number CM-7110; c. Femoral Removal Coring Reamer 11mm, Model Number CM-7111; d. Femoral Removal Coring Reamer 9 mm - Long, Model Number CM-7129; e. Femoral Removal Coring Reamer 10 mm - Long, Model Number CM-7130; f. Femoral Removal Coring Reamer 11 mm - Long, Model Number CM-7131; Orthopedic surgical instrument.

    FDA Recall
    Terminated ·Cayenne Medical Inc.·Product code HTO·April 28, 2010

    LATITUDE Patient Management System, Model 6488, Version 7.3. The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a central database.

    FDA Recall
    Terminated ·Boston Scientific CRM Corp·Product code LWS·April 10, 2013

    Ready to Use Thymo-Cide, Germicidal Detergent, containing 0.051% thymol, packaged in 1-qt. bottles. The firm name on the label is Wexford Labs, Inc., Kirkwood, MO. For disinfection of hard, non-porous surfaces (floors, walls, tables, etc.) in operating rooms, intensive care, nurseries, emergency areas, dental operatories, police, EMS, and all health care facilities.

    FDA Recall
    Terminated ·Wexford Labs Inc·Product code LRJ·September 10, 2013