BEUDAMED
    26 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 ×

    PTA-OS SIZING BALLOON, MODEL 360

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00533201·

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·H65810033201·LUKS FINGER PLUGGER 21MM

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·10304040094676·Finger spreaders 21 mm C

    KONG-TL VBR, End Plate, rectangular, M and Screw, 0° x 33 mm

    FDA UDI
    icotec AG·07640164847610·KONG-TL VBR, End Plate, rectangular, M and Scre...

    SULZER ORTHOPEDICS INC. NATURAL-HIP SYSTEM LD STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SONOS AIRES 600 (SA-600)

    FDA 510(k)
    FDA Class 2 ·Radiology

    UNO INSET II 60/6 GREY TCAP 10PK INT

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·July 7, 2024

    NA

    FDA UDI
    Zimmer, Inc.·00889024066403·

    UNO INSET II 60/6 GREY TCAP 10PK INT

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·July 7, 2024

    S-ROM M HEAD 36MM +9

    FDA Adverse Event
    Injury ·9616671 DEPUY IRELAND·Product code LPH·March 14, 2013

    COAGUCHEK® XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·February 28, 2011

    ULTRAFLEX COVERED NG ESOPHAGEAL STENT

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC IRELAND, LTD.·Product code ESW·February 27, 2008

    MESH - COMPOSIX KUGEL

    FDA Adverse Event
    Injury ·DAVOL INC.·Product code FTL·June 14, 2011

    BD EMERALD SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·October 27, 2020

    AUTOSOFT 90

    FDA Adverse Event
    Injury ·Product code FPA·May 22, 2024

    AUTOSOFT 90

    FDA Adverse Event
    Injury ·Product code FPA·May 22, 2024

    BECKMAN COULTER iQ200 Series Urine Microscopy Analyzer, Catalog Numbers: 700-3345, C10684, 700-3375, C10683, 700-3325, 700-3347, 700-3320, 700-3322, 700-3370

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code KQO·March 2, 2018

    iQ200 Series Urine Microscopy Analyzers, Part Numbers: a) 700-3320, b) 700-3370, c) 700-3345, d) 700-3347, e) C10683, f) 700-3375, g) 700-3325, h) C10684

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code LKM·December 19, 2023

    BECKMAN COULTER iQ200 Series Urine Microscopy Analyzer, Catalog Numbers: 700-3345, C10684, 700-3375, C10683, 700-3325, 700-3347, 700-3320, 700-3322, 700-3370

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·April 18, 2018