BEUDAMED
    15 results · 32ms · 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 ×

    INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Comprehensive® Shoulder System

    FDA UDI
    Biomet Orthopedics, LLC·00887868267734·

    COMPREHENSIVE SHOULDER SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304449770·

    JETSTREAM NAVITUS SYSTEM; JETSTREAM G3 SF SYSTEM; JETSTREAM G3 SE SYSTEM; JETSTREAM G3 L SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CUTERA GENESISPLUS LASER SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP.·Product code LLZ·February 28, 2014

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAM·May 15, 2013

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·May 24, 2011

    COMPREHENSIVE SHOULDER INSTRUMENTS MINI HUMERAL REAMER

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code MBF·December 18, 2025

    ARCOM XL 44-36 STD +3 HMRL BRG

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PHX·July 27, 2021

    COMP RVRS SHLDR GLNSP STD 36MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PHX·July 27, 2021

    COMP RVS TRAY CO 44MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PHX·July 27, 2021

    COMPREHENSIVE PRIMARY STEM 6MM MINI

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code MBF·February 19, 2018

    COMP AUG MINI BSPLT W TPR SM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PHX·July 27, 2021

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021