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

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    NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Philips

    FDA UDI
    Sbo Hearing A/S·05714464089598·HEARLINK 1500 BTE PP BE/TP

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776150679·Lap Needle Holder 5mm 33 cm

    SOMNOMED MAS RXA

    FDA 510(k)
    FDA Class 2 ·Dental

    GS Medical AnyPlus PEEK Cage System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    IMPL TAPERED SCR-V SBM 3. 7MM 3.5MM 8MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·March 21, 2024

    ENDOPATH* XCEL TROCAR

    FDA Adverse Event
    Injury ·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code GCJ·September 16, 2011

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 14, 2014

    SOLETRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·July 26, 2013

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    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