BEUDAMED
    10 results · 26ms · Sources: EU EUDAMED, US FDA

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    PROPPER SHARPGUARD & TRAYPAD STERIL. AID

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Preat Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092179833·Sphero Block Abutment Straumann BLT 2.9 x 3mm (...

    WUNDER TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    N-DEX BWC PINK NITRILE MEDICAL EXAMINATION GLOVE, NON STERILE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    LINEAGE(R) TRANSCEND(R) SUPERFINISHED FEMORAL HEAD

    FDA Adverse Event
    Injury ·MICROPORT ORTHOPEDICS INC.·Product code JDL·May 9, 2014

    MINIARC SLING SYSTEM

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·October 19, 2012

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·May 28, 2015

    EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use.

    FDA Enforcement
    Class II ·Terminated·Dako North America Inc.·November 11, 2015

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty

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

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021