BEUDAMED
    28 results · 25ms · 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 Regulation: Us FDA ×

    VITAL SHIELD GOLD NON-STERILE POWDERED LATEX EXAM GLOVES BLUE, WITH AND/OR WITHOUT BUBBLEGUM SCENT, AND WITH PROTEIN LAB

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Affiniti

    FDA UDI
    TORNIER, INC.·00846832023592·TUBEROSITY REAMER

    Sledgehammer

    FDA UDI
    Keystone Industries·H66810004881·SC 25 lb Pwd & 4 Qt Liq Kit, Lt Reddish Pink

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·10304040054434·Strip Crown Forms

    CURE™ ACP

    FDA UDI
    MEDITECH SPINE, LLC·B167700004880·

    CURE ACP

    FDA UDI
    SpineArt SA·07640270065830·ANTERIOR CERVICAL PLATE, 4 LEVELS L88

    CLEARWATER COLON HYDROTHERAPY (DISPOSABLE SPECULUM SPO1 LARGE & SP02 SMALL)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    REICHERT CT200 CONTACT TONOMETER

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    CURE 2.0 ACP

    FDA UDI
    SpineArt SA·07640375234247·ANTERIOR CERVICAL PLATE, 4 LEVELS L88

    CURE™ ACP

    FDA UDI
    MEDITECH SPINE, LLC·B167S1700004880·

    CURE 2.0 ACP

    FDA UDI
    SpineArt SA·07640375231826·CERVICAL 4 LEVEL TEMPLATE L88

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code NIQ·October 10, 2006

    ASR ACETABULAR CUP 56

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·March 12, 2013

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·January 31, 2011

    PUMP MMT-722NAS PRDGM INS V2.2 SK EN

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·February 21, 2008

    BAXJECT II HI-FLOW NEEDLESS TRANSFER DEVICE

    FDA Adverse Event
    Malfunction ·TAKEDA PHARMACEUTICALS U.S.A., INC.·Product code LHI·May 4, 2026

    BAXJECT II HI-FLOW NEEDLESS TRANSFER DEVICE

    FDA Adverse Event
    Malfunction ·TAKEDA PHARMACEUTICALS U.S.A., INC.·Product code LHI·May 4, 2026

    BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015

    BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143 BrightView SPECT is a gamma camera designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography Emission Computed Tomography (ECT) studies.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 12, 2013

    Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD, Inc.·August 8, 2012