BEUDAMED
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    DVAS (DVAS-M, DVAS-W)

    FDA 510(k)
    FDA Class 2 ·Dental

    Brisbane ALIF Cage

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215018283·

    ORTHO SUMMIT SAMPLE HANDLER

    FDA Adverse Event
    Malfunction ·HAMILTON BONADUZ AG·Product code JTC·August 18, 1999

    ONE STEP HCG TEST STRIP, ONE STEP HCG TEST CASSETTE, ONE STEP HCG TEST MIDSTREAM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000

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

    ANN PH NAIL RT 7X160MM

    FDA Adverse Event
    Malfunction ·ZIMMER GMBH·Product code HSB·March 30, 2026

    I-STAT EC8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code CHL·October 27, 2022

    GE Healthcare Revolution Frontier, Model Numbers: 1) 5232085-213, 2) 5873009; X-ray/computed tomography system

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare (China) Co., Ltd.·December 11, 2024

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FRN·November 18, 2008

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - AIBONITO·Product code KPE·September 1, 2011

    4MM EXTRA COARSE DIAMOND BALL

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 17, 2013

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Enforcement
    Class II ·Ongoing·Abbott Point Of Care Inc.·September 24, 2025

    GE Healthcare Revolution Frontier, Model Numbers: 1) 5232085-213, 2) 5873009; X-ray/computed tomography system

    FDA Recall
    Open, Classified ·GE Healthcare (China) Co., Ltd. 1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area Beijing China·Product code JAK·November 5, 2024

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Recall
    Open, Classified ·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025

    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