BEUDAMED
    14 results · 23ms · Sources: EU EUDAMED, US FDA

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    PKS BILL

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    PH - Cramer B4 Trainer Kit - 111100 - CB977

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588226057·PH - Cramer B4 Trainer Kit - 111100 - CB977

    BLACKSTONE SPINAL FIXATION SYSTEM STAPLE & WASHER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MAHURKAR TRIPLE LUMEN DIALYSIS CATHETER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    LIFEPAK(R) 1000 DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·July 10, 2015

    PERMACOL 10X15 1.5MM

    FDA Adverse Event
    Death ·COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES, PLC·Product code FTL·September 3, 2013

    LIFEPAK® 1000 DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC. - 3015876·Product code MKJ·April 24, 2019

    ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)

    FDA Adverse Event
    Injury ·ANGIOSCORE, INC·Product code LIT·March 29, 2016

    RSP SHOULDER

    FDA Adverse Event
    Other ·ENCORE MEDICAL, L.P.·Product code KWS·May 15, 2013

    ENRHYTHM DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code DXY·June 14, 2011

    AFFINITY 4

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code HDD·August 20, 2008

    ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)

    FDA Adverse Event
    Malfunction ·ANGIOSCORE, INC·Product code LIT·November 26, 2015

    Depuy P.F.C. E knee system, TC3 tibial insert; polyethylene tibial insert, Sz 4, 25.0 mm; Ref 96-0546.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code NJL·May 26, 2005

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024