BEUDAMED
    19 results · 20ms · Sources: EU EUDAMED, US FDA

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    AMSCO CHIMERON MEDIUM STEAM STERLILZER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    2540 BALLOON VALVE

    FDA UDI
    HANS RUDOLPH, INC.·00874750008711·2540A 4WAY TSHP INFLBAL 22MMOD

    TLIF/PLIF Disc Prep

    FDA UDI
    Life Spine, Inc.·00190837086794·

    K2M General Instruments

    FDA UDI
    VB Spine LLC·10888857531192·T-handle Size 135 mm

    VANGUARD REPROCESSED COMPRESSION GARMENT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    GMK-SPHERE 02.12.0510CRR TIBIAL INSERT FIXED SPHERE CR SIZE 5/10 MM R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·June 3, 2022

    PRONTO SPOT CHECK PULSE CO-OXIMETER

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code DQA·July 9, 2018

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·March 30, 2018

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·March 30, 2018

    PINNACLE MTL INS NEUT36IDX56OD

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD./REG. #8010379·Product code KWA·May 14, 2013

    VANCOMYCIN

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LEH·June 3, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·August 15, 2008

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·November 12, 2020

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·March 5, 2021

    Intralase FS Laser System. Laser Keratome

    FDA Recall
    Terminated ·Product code GEX·July 15, 2003

    cobas 8000 Modular Analyzer Series; Part Numbers: 1. 05964067001 cobas 8000 c 502 module

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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