BEUDAMED
    18 results · 22ms · 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 ×

    TRAUMACEM™ V+ Injectable Bone Cement

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Valence Robotic Navigation System

    FDA UDI
    ALPHATEC SPINE, INC.·00190376661643·Right Offset Accessory Rail Clamp

    n/a

    FDA UDI
    Ortho Development Corporation·00822409091669·Tibial Cut Guide +8/-2mm Right

    n/a

    FDA UDI
    Ortho Development Corporation·00822409067510·Slotted Stem Trial 17x80mm

    LERADOTECH, MODEL SC

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    AESCULAP IMPLANT SYSTEMS SIBD SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 2, 2025

    REVERS LEVER-LOCKING BROACH HANDLE

    FDA Adverse Event
    Malfunction ·ARTHREX, INC.·Product code LXH·January 10, 2024

    CARE ASSIST BED

    FDA Adverse Event
    Malfunction ·HILL-ROM PLUVIGNER·Product code FNL·May 23, 2013

    CAREASSIST BED

    FDA Adverse Event
    Malfunction ·HILL-ROM PLUVIGNER·Product code FNL·June 22, 2011

    OMNI-FLOW MODEL 4000 PLUS

    FDA Adverse Event
    Malfunction ·HOSPIRA, INC·Product code FRN·September 15, 2008

    POD PACKING COIL

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code HCG·November 8, 2017

    UNKNOWN INTACT CONSOLE

    FDA Adverse Event
    Injury ·MEDTRONIC ADVANCED ENERGY, LLC·Product code KNW·February 8, 2018

    UNKNOWN INTACT HANDLE

    FDA Adverse Event
    Injury ·MEDTRONIC ADVANCED ENERGY, LLC·Product code KNW·February 8, 2018

    UNKNOWN INTACT WAND

    FDA Adverse Event
    Injury ·MEDTRONIC ADVANCED ENERGY, LLC·Product code KNW·February 8, 2018

    POD PACKING COIL

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code HCG·October 23, 2017

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024