BEUDAMED
    22 results · 21ms · Sources: EU EUDAMED, US FDA

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    POWDER FREE LATEX PATIENT EXAMINATION GLOVE, WITH PROTEIN CONTENT LABELING CLAIM

    FDA 510(k)
    FDA Class 1 ·General Hospital

    PINNACLE®

    FDA UDI
    B. BRAUN MEDICAL INC.·04046955772797·SCB 2000ML EVA MIXING CONT. SINGLE PACK

    SOL-M™ Hypodermic Needle

    FDA UDI
    Sol-Millennium Medical, Inc.·00818392010664·Sterile hypodermic needles intended to inject f...

    1240 1 WAY VALVE

    FDA UDI
    HANS RUDOLPH, INC.·00874750009183·1240B 1WAY 15MMOD/10.5MMID PTS

    Trephine

    FDA UDI
    ELLIQUENCE, LLC·00846338002336·

    Stablecut®

    FDA UDI
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024493513·

    Stablecut®

    FDA UDI
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00846795007622·

    ALIF Disc Prep

    FDA UDI
    Life Spine, Inc.·00190837080105·

    ACTIVA RC

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPEARTIONS CO., JUNCOS·Product code MHY·November 9, 2010

    InFill Lordotic TLIF

    FDA UDI
    PINNACLE SPINE GROUP, LLC·00814729025073·

    VOCO IONOFIL MOLAR AC QUICK

    FDA 510(k)
    FDA Class 2 ·Dental

    CLEARMEDICAL/NOVAMEDIX AVI FOOT COVER, PAIR, REGULAR & LARGE SIZE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 3/10 MM R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 17, 2022

    AQUILEX FLUID CONTROL SYSTEM

    FDA Adverse Event
    Malfunction ·W.O.M. WORLD OF MEDICINE GMBH·Product code HIG·March 12, 2020

    adult defibrillation, cardioversion, pacing, monitoring Disposable Electrodes, Model P-211-M1 and P-214-M1. Product Usage: Used by trained professionals in hospitals, doctors offices, and Emergency Medical Services for adult low-energy defibrillation, transcutaneous pacing, cardioversion and monitoring.

    FDA Enforcement
    Class II ·Terminated·TZ Medical Inc.·June 5, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 14, 2013

    FRESENIUS LIBERTY CYCLER

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FKX·September 10, 2014

    ARTIC/EZE TR BALL GRVD 32+1

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LXH·May 19, 2011

    Stelkast Cross-over Acetabular Shell and Liner Hip System, Part Numbers SC3458-52, SC3474-52, SC3459-52, and SC3460-52. Intended for use in reconstruction of the articulating surface of the acetabular portion of the hip.

    FDA Enforcement
    Class II ·Terminated·Stelkast Co·April 17, 2013

    General Plastic Pack, Kit number PSS2432, PSS2432(A, PSS2717, PSS2717(A, and PSS2717(B. convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016