BEUDAMED
    22 results · 24ms · Sources: EU EUDAMED, US FDA

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    JULIET OL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Hader Bar

    FDA UDI
    Preat Corporation·00842092175439·Hader Alignment Housing

    Hader Bar

    FDA UDI
    Preat Corporation·00842092105320·Hader Alignment Housing

    DD Bio Splint P

    FDA UDI
    Dental Direkt GmbH·EDDIK101201·DD Bio Splint P are transparent dental milling ...

    Wire Speculum

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896104815·Adjustable Wire Speculum Open Blades Titanium

    Gold Marker Needle

    FDA UDI
    RIVERPOINT MEDICAL, LLC·00812444028065·Brachytherapy

    SYNTHES SACRAL BAR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    GALAXY G3 MINI 2MM X 3CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·May 20, 2020

    2520274-2013-02471

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code HWC·May 9, 2013

    PUREPOINT

    FDA Adverse Event
    Injury ·ALCON ¿ IRVINE TECHNOLOGY CENTER·Product code HQF·September 15, 2014

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·May 11, 2011

    HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINER

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code KWZ·September 26, 2016

    ANKLE LOCKING NAIL 12 X 210MM

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code HSB·October 26, 2021

    OFFSET END CAP 11X10MM .433D OFFSET

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code HSB·October 26, 2021

    GALAXY G3 MINI 1.5MM X 2CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·May 20, 2020

    Model Number L231, PROPONENT DR EL MRI Pacemaker

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

    Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·July 14, 2021

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

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

    INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)

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