BEUDAMED
    11 results · 19ms · Sources: EU EUDAMED, US FDA

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    POSEY BED

    FDA 510(k)
    FDA Class 1 ·General Hospital

    LIFEBRIDGE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    STRAUMANN NARROW NECK CROSSFIT (NNC) 03.3MM DENTAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    SILICONE ROUND DRAIN

    FDA Adverse Event
    Malfunction ·C.R. BARD, INC. (COVINGTON) -1018233·Product code GBX·November 21, 2022

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·May 15, 2013

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 11, 2014

    DEPUY ROT. PLAT. CURVED TIBIAL INSERT

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC.·Product code JDI·May 27, 2011

    THORATEC® HEARTMATE® GOGEAR®, SHOWER BAG

    FDA Adverse Event
    Malfunction ·THORATEC CORPORATION·Product code DSQ·July 9, 2024

    GMK PRIMARY TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 31, 2026

    Hoffman LRF Telescopic Strut Short Stryker Stryker Trauma AG CH-2545 Seizach Distributed in the USA by Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The use of external devices provides the surgeon with a means of bone fixation for the management of fracture and reconstructive surgery. These devices are intended only to assist healing and are not intended to replace normal bone structures. External fixation devices are intended to hold fractured bone surfaces in apposition to facilitate normal healing. While proven successful, the devices are manufactured from metal, plastic, and composite materials. No such fracture fixation device, subject to fatigue, can be expected to withstand activity levels in the same way as would a normal health bone. The external fixation system, therefore, will not be as strong, reliable or durable as a normal human bone.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·November 14, 2012

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

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