BEUDAMED
    14 results · 20ms · 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 ×

    Provata Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    MAESTRO TOTAL WRIST

    FDA UDI
    Biomet Orthopedics, LLC·00880304555273·

    Maestro™ Total Wrist

    FDA UDI
    Biomet Orthopedics, LLC·00887868240119·

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197453202·CCR Titanium Medial Blade 24x65m...

    EARLYSENSE (EVERON) SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    WS FAR INFRARED THERAPY UNIT, MODEL # TY-101 SERIES

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    T:SLIM X2 INSULIN PUMP

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OYC·December 6, 2021

    4085 SURGICAL TABLE

    FDA Adverse Event
    STERIS CORPORATION - MONTGOMERY·Product code FQO·June 20, 2013

    COULTER LH 750 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·July 27, 2011

    SJM EPIC SUPRA STENTED PORCINE HEART VALVE

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL BRASIL LTD.·Product code LWR·September 26, 2008

    LUCEA

    FDA Adverse Event
    Malfunction ·MAQUET SAS·Product code FSY·October 19, 2018

    Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·September 7, 2022

    Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM UNCUFFED , Product Code/List Number/Item Code 60P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM UNCUFFED , Product Code/List Number/Item Code 60P030; c) PAED. TRACHEOSTOMY TUBE 3.5MM UNCUFFED , Product Code/List Number/Item Code 60P035; d) PAED. TRACHEOSTOMY TUBE 4.0MM UNCUFFED , Product Code/List Number/Item Code 60P040; e) PAED. TRACHEOSTOMY TUBE 4.5MM UNCUFFED , Product Code/List Number/Item Code 60P045; f) PAED. TRACHEOSTOMY TUBE 5.0MM UNCUFFED , Product Code/List Number/Item Code 60P050; g) PAED. TRACHEOSTOMY TUBE 5.5MM UNCUFFED , Product Code/List Number/Item Code 60P055

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024