BEUDAMED
    15 results · 33ms · Sources: EU EUDAMED, US FDA

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    CastleLoc Spinal Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814527·GENUMEDI SAND SIZE I

    PHTIP DISPOSABLE ISFET CATHETER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SMARTSUCTION SOLO DEVICE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Echotip

    FDA UDI
    COOK INCORPORATED·00827002178038·Echotip Disposable Lancet Needle

    IMPAX CV REPORTING

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP.·Product code LLZ·June 11, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 15, 2011

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·September 16, 2008

    CROSSCATH SUPPORT CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·March 6, 2019

    CROSSCATH SUPPORT CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code KRA·February 26, 2019

    SMARTSET MV 40G - EO

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LOD·November 28, 2018

    CROSSCATH SUPPORT CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·June 20, 2019

    LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Version 7.5, or SERVER SW LATITUDE DRAGON AU (Australia/New Zealand), Model 6448, Version 7.5

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·May 13, 2026

    Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132

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

    Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039), Cardio Vascular-Allura (722400);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 27, 2026