BEUDAMED
    21 results · 29ms · Sources: EU EUDAMED, US FDA

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    CENTRIA SYSTEM 2 AUTOMATED METHOD/RIA

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    INSTI HIV-1/HIV-2 Test Controls

    FDA UDI
    Biolytical Laboratories Inc·06865978010376·INSTI HIV-1/HIV-2 Test Controls

    NAR Kit

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209112203·KIT, TORK RESUPPLY - BASIC

    MODIFICATION TO EBI SPINELINK SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    WATCH-PAT 200I (WP200I)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Tray

    FDA UDI
    Zimmer, Inc.·00889024068117·

    Contourable Dual Compression Plates

    FDA UDI
    Zimmer, Inc.·00889024068124·

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·October 23, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC., USA·Product code LFR·September 7, 2007

    530G INSULIN PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·May 8, 2014

    ASR ACETABULAR CUPS 52

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 801037·Product code KWA·February 15, 2013

    ASR UNI FEMORAL IMPL SIZE 46

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 801037·Product code KWA·February 15, 2013

    DEPUY ASR XL FEM IMP SIZE 43

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 801037·Product code KWA·April 4, 2013

    FCS CERAMIC 54 OR 56X28

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 801037·Product code MRA·September 25, 2018

    ASR ACETABULAR IMPLANT 52

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD - 801037·Product code KWA·August 22, 2012

    TOTAL ASR FEM IMP SIZE 46

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD - 801037·Product code KXA·August 22, 2012

    ASR TAP SLV ADAP 12/14 -1

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 801037·Product code KXA·February 27, 2019

    OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02-35, 35MM; e) 200-02-38, 38MM; f) 200-02-41, 41MM;

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·June 26, 2024

    Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·September 30, 2015

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021