BEUDAMED
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    ALL-IN-ONE CONTAINER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690189640·AK3 PS Instruments Left/Right Pan

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036026929·

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776363505·Austin Tissue Retractor

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690189633·APEX Knee System PS Instruments- Left/Right Pan...

    3-LD Set, SNAP to DIN, UNSHIELDED, A,96"

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828147200·3-LD Set, SNAP to DIN, UNSHIELDED, A,96"

    Vermed

    FDA UDI
    GRAPHIC CONTROLS ACQUISITION CORP·00009336008278·Din Lead Wire, Snap to Socket, 18", Black

    MULTI CARE THERAPEUTIC VIBRATOR

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ONTRAK TESTSTIK FOR METHAMPHETAMINE, CAT. 1986686

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·May 2, 2013

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·September 15, 2014

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    FDA Adverse Event
    Injury ·COOK, INC.·Product code MIH·May 6, 2011

    UNKNOWN

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL RESOURCES·Product code GCJ·June 8, 2018

    STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System. Model P6500, 510 (k) Numbers: K090036 Cleared 4/05/2010; K101409 cleared 8/2/2010; K102462, cleared 9/2/2010; add to file 2/24/2011. The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reuseable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.

    FDA Recall
    Terminated ·Steris Corporation Hopkins Facility·Product code MED·December 7, 2011

    Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024