BEUDAMED
    18 results · 21ms · Sources: EU EUDAMED, US FDA

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    ASTRA TECH IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    Luxe™ 2.5 Semi-custom loupe

    FDA UDI
    METREX RESEARCH, LLC·00850036373728·Semi-custom loupe with Luxe™ 2.5 plano oculars,...

    GINSBERG EYE SPECULUM

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896088191·GINSBERG EYE SPECULUM ADJUSTABLE SOLID BLADES A...

    FORA G30A BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4241

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CARDO MEDICAL FEMORAL CEMENT RESTRICTOR, MODEL 503-MCRX

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINER

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code KWZ·September 26, 2016

    2800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 30, 2013

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·May 10, 2011

    LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code MAF·August 7, 2008

    ISTENT INJECT W TRABECULAR MICRO BYPASS SYSTEM

    FDA Adverse Event
    Malfunction ·GLAUKOS CORPORATION·Product code OGO·December 7, 2020

    GALAXY G3 MINI 2.5MM X 5.5CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·August 2, 2021

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    ACCOLADE DR SL (Model L301)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model Number L121), and EL MRI (Model Number L131)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·January 22, 2025

    BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine. In most cases, the customer ordered both a BleaseFocus anesthesia workstation and a 700/900 ventilator. In some cases, the customer may order a 700/900 stand-alone ventilator would could be used with a BleaseFocus anesthesia workstation at a later date.

    FDA Enforcement
    Class II ·Terminated·Del Mar Reynolds Medical, Ltd.·December 26, 2012