BEUDAMED
    12 results · 24ms · Sources: EU EUDAMED, US FDA

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    GENISTRONG SINGLE-USE SPECIMEN RETRIEVAL BAG

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

    GENISTRONG

    FDA Adverse Event
    Malfunction ·GENICON·Product code GCJ·October 15, 2017

    Oticon

    FDA UDI
    Oticon A/S·05707131258274·H16, RITE 312 WL DBL

    MINATURE DERF NEEDLE HOLDER

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896022188·MINATURE DERF NEEDLE HOLDER TUNGSTEN CARBIDE DU...

    Ophthalmic Spatula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668102718·AGARWAL KARATE PHACO CHOPPER

    VAXCEL PORT, MODELS 45-336 AND 45-338

    FDA 510(k)
    FDA Class 2 ·General Hospital

    LUCIA

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ALTRUA

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 1, 2014

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 29, 2013

    MICRO DRILL MEDIUM STRAIGHT ATTACHMENT

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code ERL·June 13, 2011

    Achieva 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·November 29, 2023

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015