BEUDAMED
    12 results · 21ms · Sources: EU EUDAMED, US FDA

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    ZOLL X SERIES

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    PATCHASSIST LARGE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ENDOPATH ENDOCUTTER GRAY CARTRIDGE, MODEL 6R45M/GRAY CARTRIDGE RELOAD

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·December 5, 2013

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 6, 2024

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·October 1, 2014

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·May 29, 2013

    ENDO STITCH SURGIDAC 2/0 48 GRN DLU SU

    FDA Adverse Event
    Malfunction ·UNITED STATES SURGICAL·Product code KOG·May 11, 2011

    RETAINING 2.5MM HEX DRIVE R LATCHLOCK

    FDA Adverse Event
    Malfunction ·ZIMMER DENTAL·Product code NDP·August 21, 2017

    RETAINING 2.5MM HEX DRIVE R LATCHLOCK

    FDA Adverse Event
    Malfunction ·ZIMMER DENTAL·Product code NDP·September 15, 2017

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012

    Achieva 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·November 29, 2023