BEUDAMED
    21 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 ×

    3DMax Light Mesh

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SpheRx

    FDA UDI
    Nuvasive, Inc.·00887517443960·SpheRx® II Conn, 25mm Transverse Fixed

    Integra® Miltex®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780160106·Integra® Miltex® Lambert-Kay Aorta Clamp 8"

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694022767·FPS 2.7mm 0mm Step Plate

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111356438·MICHEL APPLY/REMOVE FCP 5"

    2.4MM LOCKING RECON SYSTEM

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036062040·

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694077101·FPS 2.7 0mm Step Plate Sterile Qty 5

    SQuEEZ Software

    FDA 510(k)
    FDA Class 2 ·Radiology

    FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM

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

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·June 15, 2021

    BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX¿ SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·September 22, 2021

    UNKNOWN ENDO GIA INSTRUMENT

    FDA Adverse Event
    Injury ·COVIDIEN LP LLC NORTH HAVEN·Product code GDW·October 18, 2019

    UNKNOWN ENDO GIA SULU

    FDA Adverse Event
    Injury ·COVIDIEN LP LLC NORTH HAVEN·Product code GDW·October 18, 2019

    HYDROCOIL 14-SYSTEM COIL (HES)

    FDA Adverse Event
    Injury ·MICROVENTION, INC.·Product code HCG·November 10, 2008

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 17, 2011

    75MM SELECTABLE NEW TLC

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 22, 2013

    PRODIGY AUTOCODE

    FDA Adverse Event
    Injury ·OK BIOTECH CO., LTD.·Product code NBW·October 16, 2017

    MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·August 25, 2023

    HA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin Kit) Item Nos: HAA60-09030 HAA60-09040 HAA60-10030 HAA60-10040 HAA60-11030 HAA60-11040 HAA60-11050 HAA60-12040 HAA60-12060 HAA60-13030 HAA60-13040 HAA60-13050 HAA60-13060 HAA60-13070 HAA60-14050 HAA60-14080 HAA60-14090 HAA60-15020 HAA60-15030 HAA60-15040 HAA60-15050 HAA60-15060 HAA60-16030 HAA60-16040 HAA60-16050 HAA60-16070 HAA60-16090 HAA60-17040 HAA60-17060 HAA60-17080 HAA60-18010 HAA60-18030 HAA60-18040 HAA60-18050 HAA60-18060 HAA60-18090 HAA60-20030 HAA60-20040 HAA60-20050 HAA60-20060 HAA60-20080 HAA60-20090 HAA60-22050 HAA60-22060 HAA60-25030 HAA60-25040 HAA60-25050 HAA60-25060 HAA60-30060 HAB60-09030 HAB60-10030 HAB60-10040 HAB60-11040 HAB60-11050 HAB60-12040 HAB60-12060 HAB60-13040 HAB60-13050 HAB60-13060 HAB60-14050 HAB60-15060 HAB60-16070 HAB60-16090 HAB60-17080 HAB60-18010 HAB60-18090 HAB60-20080 HAB60-20090 808200000 Product Usage: These devices are intended for osteosynthesis, external fixation of fractures or bone lengthening procedures.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019

    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021