BEUDAMED
    10,000 results · 34ms · 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.

    SCULPTOR ROBOTIC GUIDANCE ARM (RGA)

    FDA 510(k)
    FDA Class 2 ·Neurology

    Endoskeletal Components

    FDA UDI
    COLLEGE PARK INDUSTRIES, INC.·00841747181764·4-Hole Lamination Plate, Round, Tie Groove, Al

    EDWARDS RGA

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code LDF·September 18, 2018

    INSPECTION RGA 0629 SMARTPLUG

    FDA Adverse Event
    Other ·MEDENNIUM, INC.·Product code LZU·August 16, 2005

    INSPECTION RGA 0629 SMARTPLUG

    FDA Adverse Event
    Other ·MEDENNIUM, INC.·Product code LZU·August 16, 2005

    D+K USA RGA #5110

    FDA Adverse Event
    Injury ·DUCKWORTH & KENT USA LTD.·Product code MDM·October 26, 2004

    MAYFIELD MODIFIED SKULL CLAMP LOANER

    FDA Adverse Event
    Malfunction ·INTEGRA LIFESCIENCES CORPORATION OH/USA·Product code HBL·July 6, 2015

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·December 10, 2018

    EMBOLD¿ FIBERED

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KRD·November 19, 2024

    On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use. Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position in cases that involve an ascending aortic aneurysm or other associated aortic disease.

    FDA Enforcement
    Class II ·Terminated·CryoLife, Inc.·September 13, 2017

    ENDO GIA ULTRA UNIVERSAL STAPLER

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code GDW·August 18, 2016

    SALUTE FIXATION DEVICE

    FDA Adverse Event
    Malfunction ·DAVOL INC., SUB. C.R. BARD, INC.·Product code GDW·August 25, 2005

    CATHETER, PERCUTANEOUS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQY·October 19, 2022

    TRI-STAPLE 2.0

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code GDW·September 18, 2024

    ALCON IOL

    FDA Adverse Event
    Malfunction ·ALCON LABORATORIES INC·Product code HQL·September 19, 2024

    SALINE FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·INAMED-SANTA BARBARA·Product code FWM·June 22, 2005

    TRI-STAPLE 2.0

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code GDW·September 19, 2024

    TECNIS IOL

    FDA Adverse Event
    Malfunction ·JOHNSON JOHNSON SURGICAL VISION, INC.·Product code MJP·September 18, 2024

    ENDO STITCH

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code OCW·September 19, 2024

    ENDOWRIST

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC.·Product code NAY·November 15, 2024