BEUDAMED
    16 results · 23ms · Sources: EU EUDAMED, US FDA

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    OPTIS Integrated System Mobile Workstation

    FDA 510(k)
    FDA Class 2 ·Radiology

    HHM

    FDA UDI
    Oticon A/S·05707131288271·H160V2, DESIGNRITE 10 WL SOR HHM

    Crosslink Bonding Adhesives

    FDA UDI
    TP ORTHODONTICS INC·00192029000168·Blue Color Paste in Syringe 4 g (.141 oz)

    HNM SPORTS MEDICINE

    FDA UDI
    HNM STAINLESS, LLC.·00812171029960·ETHOS PRO SMALL JOINT ANCHOR XL, PEEK, 2.9mm x ...

    ZODIAC SPINAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SEDARA GAS MIXER, SEDARA SCAVENGER MODEL: 03, 04

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    HNM SPORTS MEDICINE

    FDA UDI
    HNM STAINLESS, LLC.·00842962103845·ETHOS PRO SMALL JOINT ANCHOR XL, PEEK, 2.9mm x ...

    BIVONA TRACHEOSTOMY TUBE, NEONATAL/PEDIATRIC

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code JOH·May 18, 2022

    AMPHIRION DEEP OTW

    FDA Adverse Event
    Malfunction ·INVATEC SPA·Product code DQY·June 7, 2013

    UNKNOWN DEPUY FEMORAL COMPONENT

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·June 30, 2011

    MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

    FDA Adverse Event
    C.T.M. SHANGHAI·Product code INI·October 8, 2014

    C-QUR MOSAIC

    FDA Adverse Event
    Injury ·ATRIUM MEDICAL CORPORATION·Product code FTL·October 9, 2015

    LIGASURE

    FDA Adverse Event
    Malfunction ·COVIDIEN MFG DC BOULDER·Product code GEI·March 21, 2022

    Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part Number 6290-00-690. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella and used as a guide for the matching size patella cutter.

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·September 10, 2014

    Medical Linear Accelerator

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·September 14, 2016

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012