BEUDAMED
    14 results · 21ms · Sources: EU EUDAMED, US FDA

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    Revolution Radial Head

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ZenFlex CM

    FDA UDI
    Kerr Corporation·00195062145742·.30/.06/31mm ZenFlex CM NiTi FILE REFILL PACK

    FX V 135 stem

    FDA UDI
    FX SOLUTIONS·03701037315217·FX V 135 stem TA6V Ø36/18 cementless Ti/HA

    Raw Surgical Corporation

    FDA UDI
    RAW SURGICAL CORPORATION·G508RSC01836180·DEEP GELPI RETRACTORS, 90 degree angle, 5" max ...

    I-STAT CG8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code CHL·May 25, 2023

    PACS SCAN

    FDA 510(k)
    FDA Class 2 ·Radiology

    TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INDIGO SYSTEM ASPIRATION CATHETER

    FDA Adverse Event
    Injury ·PENUMBRA, INC.·Product code DXE·August 11, 2020

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FRN·October 4, 2008

    DYN-LOCK-SCR Ø3.7 SELF-TAP L26 COCRMO

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWC·June 22, 2013

    COULTER LH 750 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·July 8, 2011

    I-STAT CHEM8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JPI·December 17, 2024

    CooperSurgical lnflatoball Latex Rubber Pessary sold as an individual unit and also part of the lnflatoball Pessary Kit. Product Usage: The lnflatoball Pessary is a single-patient use pessary manufactured from natural latex rubber and is used for treating cystocele and/or rectocele associated with procidentia or prolapse. The inflatoball Pessary contains one (1) Pessary in a double-pocketed sealed clear plastic pouch, one pocket containing the Pessary and one pocket containing the Instructions for Use (IFU).

    FDA Enforcement
    Class II ·Terminated·CooperSurgical, Inc.·May 17, 2017

    Olympus Sterile Optical Laser Fiber, single use and reusable

    FDA Enforcement
    Class II ·Terminated·Quanta System, S.p.A.·June 16, 2021