BEUDAMED
    27 results · 32ms · Sources: EU EUDAMED, US FDA

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    CARDIOHELP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CARDIOHELP SYSTEM

    FDA Adverse Event
    Injury ·MAQUET CARDIOPULMONARY AG·Product code DTQ·February 23, 2015

    HLM TUBING SET W/BIOLINE COATING

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DWE·March 25, 2016

    neria™ detach

    FDA UDI
    Unomedical A/S·05705244000957·Single use infusion set for subcutaneous infusi...

    TCOYF FERTILITY SOFTWARE VERSION 1.0

    FDA 510(k)
    FDA Unclassified ·Unknown

    PROSAFE SAFETY SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HAHN TAPERED IMPLANT Ø5.0 X 10 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·August 22, 2024

    HAHN TAPERED IMPLANT Ø5.0 X 10 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·July 12, 2025

    HAHN TAPERED IMPLANT Ø5.0 X 10 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·February 17, 2023

    LIFEPAK(R) 1000 DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·May 9, 2013

    ASAHI PROWATERFLEX PTCA GUIDE WIRE

    FDA Adverse Event
    Injury ·AV-ASAHI·Product code DQX·September 19, 2014

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 23, 2011

    ATTUNE RP TIB BASE SZ 8 CEM

    FDA Adverse Event
    Injury ·DEPUY IRELAND - 9616671·Product code NJL·December 6, 2019

    ATTUNE MEDIAL ANAT PAT 38MM

    FDA Adverse Event
    Injury ·DEPUY IRELAND - 9616671·Product code NJL·December 6, 2019

    ATTUNE PS RP INSRT SZ 7 14MM

    FDA Adverse Event
    Injury ·DEPUY IRELAND - 9616671·Product code JWH·December 6, 2019

    ATTUNE PS FEM RT SZ 7 CEM

    FDA Adverse Event
    Injury ·DEPUY IRELAND - 9616671·Product code JWH·December 6, 2019

    Oxygen Masks, Elongated (Under Chin), Adult High Conc., Non-Rebreather, 7ft O2 Tubing, Check Valve, Two Side Valve, Product Code 108-E

    FDA Enforcement
    Class II ·Terminated·ConvaTec, Inc·June 14, 2017

    Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.

    FDA Recall
    Open, Classified ·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code EOQ·September 25, 2023

    Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023

    Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

    FDA Enforcement
    Class II ·Terminated·Senseonics, Inc.·November 6, 2019