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

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    ORTHOPAT ADVANCE PERIOPERATIVE AUTOTRANSFUSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ARTHOCARE SPARTAN PEEK SUTURE IMPLANT SYSTEM; PUNCH TAP ; EXTRACTION TOOL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    REFLEX BALLON GUIDE CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 4 RIGHT

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 9, 2017

    GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 4 / 10 MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·January 16, 2019

    CONSERVE(R) TOTAL HEAD W/BFH

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code KWA·May 21, 2013

    TANDEM T: SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE INC.·Product code LZG·September 18, 2014

    OMNISPAN 12 DEGREE MENISCAL FASTENER

    FDA Adverse Event
    Malfunction ·DEPUY MITEK·Product code MBI·June 13, 2011

    GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 2 / 17 MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·January 26, 2021

    GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 2 R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·June 15, 2022

    REDUCTION FORCEPS WITH POINTS BROAD-RATCHET

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HTD·August 24, 2018

    GMK-PRIMARY TIBIAL INSERT UC FIXED 3 / 17 MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·January 27, 2016

    CD HORIZON® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·November 25, 2024

    GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 4 LEFT

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 30, 2016

    GMK PS TIBIAL INSERT SIZE 3 / 17 MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL, SA·Product code JWH·June 11, 2015

    Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 30, 2015