BEUDAMED
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    QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols

    FDA 510(k)
    FDA Class 2 ·Immunology

    ProLift Trial

    FDA UDI
    Life Spine, Inc.·00190837087692·

    ECO SUPERGEL

    FDA 510(k)
    FDA Class 2 ·Radiology

    CLARIS NON-STICK BIPOLAR FORCEPS

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

    DS2ADV AUTO CPAP

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·April 2, 2024

    UNKNOWN MESH PRODUCT (EWHU)

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·June 7, 2013

    VISTA BASIC SAFETY INFUSION SYSTEM

    FDA Adverse Event
    Malfunction ·B. BRAUN MEDICAL, INC.·Product code FRN·June 20, 2011

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·September 5, 2008

    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

    IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.

    FDA Enforcement
    Class II ·Terminated·Medical Intelligence Medizintechnik Gmbh·July 31, 2019