BEUDAMED
    16 results · 28ms · Sources: EU EUDAMED, US FDA

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    ENDO-EXPRESS (R) HANDPIECE

    FDA 510(k)
    FDA Class 1 ·Dental

    MicroSelectron Digital

    FDA UDI
    Nucletron B.V.·08717213033269·Coupling Treatment Tube for Metal Needles (24)

    RESTORIS

    FDA UDI
    MAKO SURGICAL CORP.·00848486002749·MCK PATELLA SIZING GUIDE (32mm/35mm)

    RESTORIS

    FDA UDI
    MAKO SURGICAL CORP.·00848486023454·MCK PATELLA SIZING GUIDE (26mm/29mm)

    RESTORIS

    FDA UDI
    MAKO SURGICAL CORP.·00848486023461·MCK PATELLA SIZING GUIDE (38mm/41mm)

    FIGURE 8 STERNOTOMY CLOSURE DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ZOLL PAD WITH CPR AID

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR·Product code NIQ·August 16, 2023

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR·Product code MGB·March 20, 2023

    PINNACLE MTL INS NEUT36IDX52OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·May 14, 2013

    ASR ACETABULAR CUPS 50

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 13, 2011

    STARCLOSE VASCULAR CLOSURE SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR - REDWOOD CITY·Product code MGB·August 13, 2008

    GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code MAF·May 17, 2019

    DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HTJ·January 3, 2023

    DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HTJ·February 16, 2022

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021