BEUDAMED
    13 results · 51ms · Sources: EU EUDAMED, US FDA

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    PALM-PRO POWDER FREE NITRILE EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    NA

    FDA UDI
    Smith & Nephew, Inc.·00885556008126·HOKE OSTEOTOME 5.16 X 6

    JOBST Anti-Em

    FDA UDI
    BSN MEDICAL, INC.·00035664114640·ANTI EM TH XXL-REG W 6 EN FR ES

    MicroSelectron Digital

    FDA UDI
    Nucletron B.V.·08717213033672·Coupling Treatment Tube for 5F Flexibles (4)

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450752319·

    TIGERPAW SYSTEM II

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

    RX VIATRAC 14 PERIPHERAL DILATATION CATHETER, OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER, RX HERCULINK 14 BILIARY STN

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INFUSOMAT SPACE - US VERSION

    FDA Adverse Event
    Malfunction ·B. BRAUN MELSUNGEN AG·Product code FRN·April 30, 2013

    ASR ACETABULAR CUPS 48

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 13, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·August 14, 2008

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Model Number L131, ESSENTIO DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025