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

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    ENSEAL G2 TISSUE SEALER, STRAIGHT JAW, ENSEAL G2 TISSUE SEALER, CURVED JAW, ENSEAL TRIO TISSUE SEALER, 3 MM CURVED JAW,

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

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B16741314350·

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B1674131435060·

    ArgenIS

    FDA UDI
    ARGEN CORPORATION, THE·D818131435·TiBase NC RP G1.2 E

    Plateau C

    FDA UDI
    Life Spine, Inc.·00190837093655·

    IMIX PANORAD AND SOMARAD

    FDA 510(k)
    FDA Class 2 ·Radiology

    BONESOURCE BVF

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CART 9733856 S7 STAFF ASSEMBLED 110V

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·June 4, 2019

    STEALTHSTATION® S7´

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·June 20, 2019

    CART 9733856 S7 STAFF ASSEMBLED 110V

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·June 17, 2019

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE REHABILITATION EQUIP·Product code CAW·October 1, 2014

    7.5MM REVERE PEDICLE SCREW 50MM.

    FDA Adverse Event
    Injury ·GLOBUS MEDICAL, INC.·Product code NKB·May 10, 2013

    SIGMA 100 S

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code DXY·June 16, 2011

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI18 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No

    FDA Enforcement
    Class I ·Ongoing·Edwards Lifesciences, LLC·July 16, 2025

    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