BEUDAMED
    9 results · 29ms · 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 ×

    Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit

    FDA 510(k)
    FDA Class 2 ·Microbiology

    T-FORM EXTREMITY IMMOBILIZER, MODEL RT-6060

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODIFICATION TO: FOX PLUS PTA CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 11, 2025

    GYNECARE TVT RETROPUBIC SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·June 20, 2013

    INFUSO.R.

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011

    AUTOLUBE-III

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code GEY·October 17, 2014

    Ch24 round silicone catheter, Diameter: 8 mm, Perforated section: 230 mm, Total length: 600 mm, Reference Code R9900099. Thoracic/abdominal cavity drain catheter.

    FDA Enforcement
    Class II ·Terminated·RanD S.r.l.·July 21, 2021

    Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024