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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    EFILM WORKSTATION WITH MODULES

    FDA 510(k)
    FDA Class 2 ·Radiology

    SIMIDUR S1S

    FDA 510(k)
    FDA Class 2 ·Dental

    NARKOMAT, MODEL 2000

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    HEMOCUE GLUCOSE 201+ SYSTEM

    FDA Adverse Event
    Malfunction ·HEMOCUE AB·Product code CGA·July 18, 2017

    HEMOCUE GLUCOSE 201+ SYSTEM

    FDA Adverse Event
    Malfunction ·HEMOCUE AB·Product code CGA·July 18, 2017

    HEMOCUE GLUCOSE 201+ ANALYZER

    FDA Adverse Event
    Malfunction ·HEMOCUE AB·Product code LFR·May 23, 2011

    GLUCOSE 201+ ANALYZER

    FDA Adverse Event
    Malfunction ·HEMOCUE AB·Product code CGA·February 26, 2015

    GLUCOSE 201+ ANALYZER

    FDA Adverse Event
    Malfunction ·HEMOCUE AB·Product code CGA·February 26, 2015

    GLUCOSE 201+ ANALYZER

    FDA Adverse Event
    Malfunction ·HEMOCUE AB·Product code CGA·February 26, 2015

    GLUCOSE 201+ ANALYZER

    FDA Adverse Event
    Malfunction ·HEMOCUE AB·Product code CGA·February 26, 2015

    GLUCOSE 201+ ANALYZER

    FDA Adverse Event
    Malfunction ·HEMOCUE AB·Product code CGA·February 26, 2015

    GLUCOSE 201+ ANALYZER

    FDA Adverse Event
    Malfunction ·HEMOCUE AB·Product code CGA·February 26, 2015

    GLUCOSE 201+ ANALYZER

    FDA Adverse Event
    Malfunction ·HEMOCUE AB·Product code CGA·February 26, 2015

    HEMOCUE GLUCOSE 201+ SYSTEM

    FDA Adverse Event
    Malfunction ·HEMOCUE AB·Product code LFR·August 18, 2014

    POLARCATH

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - SAN JOSE·Product code DQY·March 26, 2013

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·March 16, 2011

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDIC INC.·Product code KWP·March 28, 2008

    ULTRA FAST-FIX AB ASSEMBLY-REVERSE CURVE-Absorbable Suture anchor Product Number: 72201495

    FDA Enforcement
    Class II ·Ongoing·Smith & Nephew, Inc.·October 28, 2020

    Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA6322, AA6324, AA6408, AA6410, AA6412, AA6414, AA6416, AA6418, AA6420, AA6422, AA6424, AA6C18, AA6C20, AA6C22, and AA6C24.

    FDA Enforcement
    Class II ·Ongoing·Coloplast Manufacturing US, LLC·January 22, 2025

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014