BEUDAMED
    17 results · 27ms · 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 ×

    RAMP MYOGLOBIN ASSAY

    FDA 510(k)
    FDA Class 2 ·Immunology

    Silverbolt/Mainframe

    FDA UDI
    Choice Spine, LP·10885862163509·

    mahe medical GmbH

    FDA UDI
    mahe medical gmbh·04050659174160·6.5 Cancellous Bone Screw, hex, _x000D_...

    Integrity-SI Fusion System

    FDA UDI
    Lincotek Medical LLC·B57112521012040D0·12 x 40 mm Anodized SI Implant

    6.5 Cancellous Bone Screw, hex, St.Steel, L 40 mm

    FDA UDI
    mahe medical gmbh·EMAH00100120400·6.5 Cancellous Bone Screw, hex, St.Ste...

    Imagescan HD

    FDA UDI
    SKANRAY TECHNOLOGIES LIMITED·08904269400590·Imagescan HD Floor stand is High Frequency Extr...

    FMS SOLO

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SLEEVED FILTER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ROUND DIAMOND BUR, ELITE

    FDA Adverse Event
    Malfunction ·STRYKER IRELAND LTD.·Product code HBE·December 22, 2009

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·May 14, 2007

    2520274-2013-01569

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code LXH·March 20, 2013

    BRAVO

    FDA Adverse Event
    Malfunction ·GIVEN IMAGING LTD.·Product code FFT·February 28, 2011

    ENDOPATH ETS FLEX

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code KOG·September 9, 1997

    PIPELINE

    FDA Adverse Event
    Injury ·MEDTRONIC COVIDIEN·Product code OUT·March 29, 2017

    Sure Vue Color Staph 150T, Sure Vue Color Staph 300T, Sure Vue SELECT Staph, biokit SELECT Staph 75T The product is used as an aid in the identification of Staphylococcus aureus from Culture

    FDA Enforcement
    Class II ·Terminated·Integrated Science Systems Inc·June 15, 2016

    UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022