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

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    OBC BONE ANCHORED HEARING AID SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    PROXIMAL LATERAL TIBIA PLATE, RIGHT, 8 HOLE

    FDA UDI
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665039405·

    MEDPOR COATED TEAR DRAIN

    FDA 510(k)
    FDA Unclassified ·Unknown

    THERMO DMA DATA-CAL CALIBRATOR, MODEL 1905-050

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·November 5, 2014

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·April 29, 2013

    VANGUARD CR-LIPPED TIBIAL BEARING

    FDA Adverse Event
    BIOMET·Product code JWH·April 4, 2011

    SPACEMAKER BLUNT TIP TROCAR 10MM

    FDA Adverse Event
    Malfunction ·PONCE - USS·Product code GCJ·July 25, 2008

    BLUNT TIP SCREW, 4X40MM

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·February 27, 2023

    PROXIMAL HUMERUS, RIGHT, LONG, 8.5X240MM

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·February 27, 2023

    AFFIXUS SCREW TRAUMA IMPL WIN GEN

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·May 2, 2023

    J-Plasma Precise 360(R), Catalog Numbers: BVX-330BR, BVX-330NR, BVX-450BR, BVX-450NR

    FDA Recall
    Terminated ·Bovie Medical Corporation·Product code GEI·February 8, 2018

    J-Plasma Precise(R), Catalog Numbers: BVX-150B, BVX-150N, BVX-330B, BVX- 330N, BVX-450B, BVX-450N

    FDA Recall
    Terminated ·Bovie Medical Corporation·Product code GEI·February 8, 2018

    J-Plasma Precise(R) FLEX, Catalog Number: BVX-500BF

    FDA Recall
    Terminated ·Bovie Medical Corporation·Product code GEI·February 8, 2018

    J-Plasma Precise(R) OPEN, Catalog Numbers: BVX-044-BPP, BVX-044-BPS, BVX-150-BPP, BVX-150-BPS

    FDA Recall
    Terminated ·Bovie Medical Corporation·Product code GEI·February 8, 2018

    J-Plasma(R) Handpiece, Catalog Numbers: GS-018C, GS-270C, BVX-270B

    FDA Recall
    Terminated ·Bovie Medical Corporation·Product code GEI·February 8, 2018

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·July 22, 2015