BEUDAMED
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    ASO/CRP/RF CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    TOTAL KNEE - 247546 Procedure tray Catalog Number: BFTK01Z

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems Inc·July 17, 2024

    LATEX EXAM GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    BrainScope TBI (Model: Ahead 400)

    FDA 510(k)
    FDA Class 2 ·Neurology

    LIFEVEST WCD 4000 SYS

    FDA Adverse Event
    Malfunction ·ZOLL MANUFACTURING CORPORATION·Product code MVK·June 27, 2014

    POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER

    FDA Adverse Event
    Malfunction ·CORDIS DE MEXICO·Product code DQY·February 28, 2013

    ASR ACETABULAR CUPS 52

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·January 31, 2011

    HAND PACK-Procedure Kit Catalog Number: WEHD16B

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems Inc·July 17, 2024

    FOOT ANKLE-LF Procedure tray Catalog Number:CCFA51B

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems Inc·July 17, 2024

    American Contract Systems Extremity convenience kit, American Contract Systems Hand Pack convenience kit, and American Contract Systems Total Knee Pack convenience kit

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems, Inc.·August 14, 2024