BEUDAMED
    28 results · 26ms · Sources: EU EUDAMED, US FDA

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    ALYTE Y-MESH GRAFT

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

    Luxe™ 2.5 Semi-custom loupe

    FDA UDI
    METREX RESEARCH, LLC·00850036373698·Semi-custom loupe with Luxe™ 2.5 plano oculars,...

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111373114·COVER FOR 10-1738 & 10-1760

    Best Medical International

    FDA UDI
    BEST MEDICAL INTERNATIONAL, INC.·00841365107092·

    Sklar

    FDA UDI
    SKLAR CORPORATION·30649111376850·COVER FOR 10-1738 PK/12

    Sklar®

    FDA UDI
    SKLAR CORPORATION·30649111383742·COVER - 10-1738 & 10-1760 PK 6

    AGILENT COMPONENT MONITORING SYSTEM; AGILENT INVASIVE BLOOD PRESSURE MODULE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ATRICURE BIPOLAR COAGULATION SYSTEM

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

    VERSACARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·April 30, 2013

    EVIS EXERA II BRONCHOVIDEOSCOPE

    FDA Adverse Event
    Injury ·OLYMPUS MEDICAL SYSTEM CORP.·Product code EOQ·August 28, 2014

    RESTORE PRIME ADVANCED

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·May 11, 2011

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·June 29, 2018

    ANTI-A (MURINE MONOCLONAL) SERIES 1

    FDA Adverse Event
    Malfunction ·IMMUCOR·Product code KSZ·February 10, 2010

    HANCOCK AORTIC BIOPROSTHETIC HEART VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code LWR·October 4, 2019

    HANCOCK II MITRAL BIOPROSTHETIC HEART VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code LWR·October 4, 2019

    HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code DYE·October 4, 2019

    GALAXY G3 MINI 2.5MM X 5.5CM

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

    Syngo.via picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016

    Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016

    Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Azurion 3 M12, Model Number 722063. 2. Azurion 3 M15, Model Number 722064. 3. Azurion 7 B12, Model Number 722067. 4. Azurion 7 B20, Model Number 722068. 5. Azurion 7 M12, Model Number 722078. 6. Azurion 7 M20, Model Number 722079. 7. Azurion 3 M12, Model Number 722221. 8. Azurion 3 M15, Model Number 722222. 9. Azurion 7 M12, Model Number 722223. 10. Azurion 7 M20, Model Number 722224. 11. Azurion 7 B12, Model Number 722225. 12. Azurion 7 B20, Model Number 722226. 13. Azurion 5 M12, Model Number 722227. 14. Azurion 5 M20, Model Number 722228. 15. Azurion 7 M20, Model Number 722282.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·September 10, 2025