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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    NAGASHIMA SU-A CEILING MOUNT UNIT FOR

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    Total Foot System 2

    FDA UDI
    Smith & Nephew, Inc.·00885556838662·2.2MM PLATE LOCKING SCREW 14MM

    Integra® Total Foot System

    FDA UDI
    Ascension Orthopedics, Inc.·10381780119050·The locking forefoot screw is used in the Integ...

    Tranquil-L™

    FDA UDI
    NEXUS SPINE, L.L.C.·B6788220140·12mm Right Handed Nerve Root Retractor

    16PW - Class A & BBP 21 - Poly White

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588620145·16PW - Class A & BBP 21 - Poly White

    DYNEX-44 DIAGNOSTIC ULTRASOUND IMAGING

    FDA 510(k)
    FDA Class 2 ·Radiology

    EXALT Model B Single-Use Bronchoscope

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

    EVIDENT

    FDA Adverse Event
    Malfunction ·COVIDIEN MFG DC BOULDER·Product code NEY·January 14, 2019

    TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·April 4, 2018

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code NEW·April 4, 2018

    O-ARM 1000 IMAGING SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC. (LITTLETON)·Product code OXO·May 20, 2014

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·November 7, 2012

    CRYSTALLINE

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·September 1, 2010

    OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01 -Power Control Console 2 REF ECOS-450-0021-00 -OsteoMed OsteoPower Power Console 2i REF 450-0005-00 -OsteoMed D-Power Control Console 2i REF 450-0005-01 -Power Control Console 2i REF ECOS-450-0005-00 OsteoMed Footswitches: -OsteoMed BMF Footswitch REF 450-0390 -D-Bi-Directional Master Footswitch REF 450-0380 -D-Uni-Directional Footswitch II REF 450-0350 -D-Bi-Directional Footswitch II REF 450-0360 -D-Uni-Directional Master Footswitch REF 450-0370

    FDA Enforcement
    Class II ·Ongoing·Osteomed, LLC·December 15, 2021

    Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 121701060 121701062 121711048 121711052 121712050 121712052 121712056 121722048 121722050 121722052 121722054 121722056 121722058 121722060 121722062 121731048 121731050 121731052 121731054 121731056 121731058 121731060 121731062 121732048 121732050 121732052 121732054 121732056 121732058 121732060 121732062 121732064 - Product Usage: The PINNACLE CUP devices are part of the Pinnacle Hip Solution for the anatomic reconstruction of the hip joint, which promotes prosthetic joint load and function.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·January 13, 2021