BEUDAMED
    10 results · 19ms · 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 ×

    PROCAINAMIDE ENZYME IMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    SURGISTAR

    FDA UDI
    SURGISTAR, INC.·00878799001115·

    Sklar

    FDA UDI
    SKLAR CORPORATION·50649111440456·ROCH-PEAN FCP5.5 INCHES STR CS/25

    Matrix Data Management System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LIFESCOPE 8, OEC-8120 PORTABLE PATIENT MONITOR REC

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·February 14, 2013

    TOTAL HIP BALL 28MM +3

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JDI·January 7, 2011

    REDUCTION FORCEPS WITH POINTS BROAD-RATCHET

    FDA Adverse Event
    Malfunction ·SYNTHES TUTTLINGEN·Product code HTD·July 29, 2014

    Laparotomy Pack, part number 006268-9 Laparotomy Pack, part number AMS4418(A Laparotomy Pack, part number PSS2190(A

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Number/Item Code 750160; b) AIRE-CUF TRACHY TUBE 7.0MM MID-RANGE , Product Code/List Number/Item Code 750170; c) AIRE-CUF TRACHY TUBE 8.0MM MID-RANGE , Product Code/List Number/Item Code 750180

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024