BEUDAMED
    20 results · 35ms · 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.

    RAYSTATION

    FDA 510(k)
    FDA Class 2 ·Radiology

    INTRAMEDULLARY BONE PLUG

    FDA UDI
    Biomet Orthopedics, LLC·00880304227361·

    LCU Hip System - Instruments

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575414291·Bone awl, reusable - General Instrument

    PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MASIMO RESPONSABLE OXIMETRY SENSORS MODEL S2-25/25D; S2-20/20D

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523138517·Broach, 30 X 26, 17mm Height 17° Hyperlordotic

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523136506·Ti-6Al-4V ALIF Implant 30 X 26, 17mm Height 17°...

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523137619·Trial, 30 X 26, 17mm Height 17° Hyperlordotic

    STEM: AMISTEM H HA COATED STD STEM SIZE 1

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·May 26, 2021

    2520274-2013-02819

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code JDQ·May 24, 2013

    PARADIGM INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LZG·September 30, 2014

    THE PRIMARY FEMORAL STEM

    FDA Adverse Event
    Injury ·ZIMMER INC.·Product code LPH·June 14, 2011

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZE·November 21, 2013

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZE·November 20, 2013

    Tearaway Introducer, Model # VS203, VS303, 510 K # 130687, packaged individually in a pouch, 5 pouches per carton, lot # MBZ140, MBZL450, MBZV930 MBZZ490 Product Usage: The 2F and 3F Vascu-Sheath Tearaway Introducer is intended for percutaneous venous access by modified Seldinger Technique in neonates, infants and children.

    FDA Enforcement
    Class II ·Terminated·Medical Components, Inc dba MedComp·June 15, 2016

    Tearaway Introducer, Model # VS203, VS303, 510 K # 130687, packaged individually in a pouch, 5 pouches per carton, lot # MBZ140, MBZL450, MBZV930 MBZZ490 Product Usage: The 2F and 3F Vascu-Sheath Tearaway Introducer is intended for percutaneous venous access by modified Seldinger Technique in neonates, infants and children.

    FDA Recall
    Terminated ·Medical Components, Inc dba MedComp·Product code DYB·May 5, 2016

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZE·May 8, 2014

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZE·September 24, 2013

    VENTED HUMIDIFICATION CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·November 7, 2013

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

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