BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    Fibercure

    FDA 510(k)
    FDA Class 2 ·Dental

    K-Systems

    FDA UDI
    Coopersurgical, Inc.·00888937025033·G95 Mini Incubator

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112618·BARRON CORNEAL PUNCH 7.5MM

    SENOVA(R) BLOOD GLUCOSE MONITOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    REAGENT, RUSSEL VIPER VENOM - LA CONFIRM

    FDA 510(k)
    FDA Class 1 ·Hematology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 11, 2024

    VITAL VUE X-LONG ORTH TIP W/EX METAL SUC

    FDA Adverse Event
    Malfunction ·TIJUANA - USS·Product code GCX·November 7, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011

    AUTOLUBE-III W/20' HOSE

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

    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

    Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025