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

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    CERETENE SOLUBLE IMPLANT MATERIAL

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    NexxZr™ / W-98-14-UT-A400-ML

    FDA UDI
    SAGEMAX BIOCERAMICS, INC·00842271138651·

    Enza 1.0

    FDA UDI
    CAMBER SPINE TECHNOLOGIES, LLC·B030CB1030470·Jaw Assembly, 26mm x 32mm

    FOTONA DUALIS ND:YAG LASER SYSTEM, FOTONA TWINLIGHT ND:YAG LASER SYSTEM

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

    AMBULATORY ENTERAL NUTRITION PUMP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172971246·

    SSW CARBIDE CAD CAM

    FDA UDI
    Ss White Burs, Inc.·D690SSWAMG10304720022·CAD/CAM CARBIDE DURADI SSWAMG-103047-20-02 - 1 ...

    SSW CARBIDE CAD CAM

    FDA UDI
    Ss White Burs, Inc.·D690SSWAMG10304720012·CAD/CAM CARBIDE LAZER SHARP SSWAMG-103047-20-01...

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·May 9, 2013

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·September 19, 2014

    INTERMATE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code FRN·May 25, 2011

    SMR HUMERAL HEAD Ø48 MM

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code KWT·January 27, 2023

    ASAHI CONFIANZA PRO 8-20

    FDA Adverse Event
    Malfunction ·ASAHI INTECC CO., LTD.·Product code DQX·August 23, 2016

    ASAHI CONFIANZA PRO 8-20

    FDA Adverse Event
    Injury ·ASAHI INTECC CO., LTD.·Product code DQX·April 14, 2016

    ASAHI CONFIANZA PRO 8-20

    FDA Adverse Event
    Injury ·ASAHI INTECC CO., LTD.·Product code DQX·June 6, 2016

    PEN NDL 32G 4MM HP 100 BOX 1200 US

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·March 22, 2021

    Sensis / Sensis Vibe systems with software version VD12 and equipped with HP Flex Pro-C PC. Diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies Model Numbers: Sensis Vibe Hemo 11007641 Sensis Vibe Combo 11007642 Sensis 10764561 Postprocessing Workstation 6648161 SIS Server 6648153

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·March 10, 2021

    Sensis/ Sensis Vibe Hemo systems with VD12A software as follows: Dedicated SIS Server- 6648153 Sensis Post-Processing Workstation- 6648161 Sensis- 10764561 VM Virtual Server- 10765502 Sensis High-End Servers- 10910620 Sensis Vibe Hemo- 11007641 Sensis Vibe Combo- 11007642 Sensis Vibe is a recording and procedure data management system for interventional cardiology, interventional radiology, surgical procedures performed in a hybrid OR and electrophysiology

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·April 28, 2021

    Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·November 6, 2024

    1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199 3. Sensis Vibe Combo, material # 11007642; UDI: 04056869010205 The Sensis recording system is a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac, interventional Radiology, and surgical studies.

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·January 26, 2022