BEUDAMED
    10 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 ×

    PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Bi-Metric® Revision Hip System

    FDA UDI
    Biomet Orthopedics, LLC·00887868261510·

    BI-METRIC REVISION HIP SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304003507·

    BI-METRIC(R) HEAD/NECK PROVISIONAL

    FDA UDI
    Biomet Orthopedics, LLC·00880304307544·

    POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SINGLE USE ESOPHAGEAL MANOMETEY CATHETERS AND SINGLE USE ANO-RECTAL MANOMETRY CATHETERS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·June 11, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·July 14, 2011

    ONE TOUCH ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code NBW·September 9, 2008

    OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021