BEUDAMED
    16 results · 18ms · Sources: EU EUDAMED, US FDA

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    BUN REAGENT KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    TruLock

    FDA UDI
    Rmo, Inc.·00885797644893·TRULOCK Light Activated Adhesive Kit (40 Capsule)

    BaseVac

    FDA UDI
    R. E. Morrison Equipment Inc·D13028000710·2SUR4.40-3-3P | 3P 14 User Dual Surgical Vacuum...

    NAR Kit

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209100415·KIT, CCR-MEDIC TRAUMA PACK - ODG

    Enova Illumination

    FDA UDI
    Enova Illumination, Inc.·00810186670030·Axis Elite Neck Battery Cable

    Enova Illumination

    FDA UDI
    Enova Illumination, Inc.·00810186670047·Axis Elite Hip Battery Extension Cable

    ORTHO ARCH

    FDA UDI
    Ortho Arch Company Inc·D9098000711·PRECISION LIGATURE DIRECTOR - BLUE HANDLE

    SIDEKICK RAIL FIXATOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SYNTHETIC POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    MINICAP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SWINFORD·Product code KDI·May 8, 2014

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·October 12, 2012

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 11, 2010

    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

    ophthafutur C3F8 GAS (Set 1 Typ 2 & Set 2 REF 800071)

    Basic UDI-DI
    EU MDD · Eu Md Class 2b ·Pharmpur GmbH·1 device

    Ophthafutur C2F6 GAS (Set 1 Typ 2 & Set 2 REF 800071)

    Basic UDI-DI
    EU MDD · Eu Md Class 2b ·Pharmpur GmbH·1 device

    Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.1.1.X;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS·November 5, 2025