BEUDAMED
    10 results · 28ms · Sources: EU EUDAMED, US FDA

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    SCREW EXTRACTION DEVICE AND THREAD CLEANING TAP

    FDA 510(k)
    FDA Class 2 ·Dental

    PACING/PSI KIT: 5 FR/6 FR 2-L

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC.·Product code LDF·April 15, 2015

    XIA TITANIUM AND 4.5 SPINAL SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Inclusive Abutments

    FDA 510(k)
    FDA Class 2 ·Dental

    TITANIUM NEXGEN LCCL FEMORAL SZ C-LT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·August 21, 2018

    23MM MOD REV HIP BODY/BOLT STDCOMPONENT LEVEL 9006-1-023

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code LZO·February 14, 2013

    AKREOS ADVANCE ASPHERIC LENS

    FDA Adverse Event
    Injury ·BAUSCH & LOMB·Product code HQL·January 11, 2011

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·July 22, 2014

    NEXGEN LEGACY POSTERIOR STABILIZED ARTICULAR SURFACE

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·June 16, 2016

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS, REF 130-32-51 b. NOVATION GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS, REF 130-36-52 c. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 3 CUPS, REF 130-40-53 d. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 4 CUPS, REF 130-40-54 e. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 5 CUPS, REF 130-40-55 f. NOVATION GXL LINER LIPPED 32MM ID, GROUP 1 CUPS, REF 132-32-51 g. NOVATION GXL LINER LIPPED 36MM ID GROUP 2, REF 132-36-52 h. NOVATION GXL LINER LIPPED 40MM ID, GROUP 3 CUPS, REF 132-40-53 i. NOVATION GXL LINER LIPPED 40MM ID, GROUP 4 CUPS, REF 132-40-54 j. NOVATION GXL LINER LIPPED 40MM ID, GROUP 5 CUPS, REF 132-40-55 k. NOVATION GXL LINER +5 LAT 40MM GROUP 3 CUPS, REF 136-40-53 l. NOVATION GXL LINER +5 LAT 40MM ID GROUP 4 CUPS, REF 136-40-54 m. NOVATION GXL LINER +5 LAT 40MM ID GROUP 5 CUPS, REF 136-40-55 n. NOVATION GXL LINER 10 DEG FACE 40MM ID, GRP 3 CUP, REF 138-40-53 o. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 4 CUP, REF 138-40-54 p. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 5 CUP, REF 138-40-55

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022