BEUDAMED
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    TRANS DISTAL JOINT FINGER EXTEN. SPLINT

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209131051·

    SURE-SNAP

    FDA UDI
    Gc Orthodontics America Inc.·E53580171400001·SURE-SNAP 2. MOLAR UPR RGT SZ 14

    FORA TD-3224 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MERCURY MEDICAL HYPERINFLATION BAG SYSTEM, MODEL 83-900-0149

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    COBAS E 801 ANALYTICAL UNIT

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·November 11, 2024

    COBAS E 801 IMMUNOASSAY ANALYZER

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·January 16, 2025

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 8, 2014

    GYNECARE MORCELLEX* TISSUE MORCELLATOR

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code HET·October 23, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 27, 2007

    dS Breast 7ch 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 4, 2024

    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

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022