BEUDAMED
    29 results · 27ms · Sources: EU EUDAMED, US FDA

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    CLEARJET

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    andorate® Air Water Channel Cleaning Adapter + 4-piece Valve Kit

    FDA UDI
    GA Health Company Limited·04897106958641·

    Air Water Channel Cleaning Adapter + Champion 4-piece Valve Kit

    FDA UDI
    GA Health Company Limited·04897106958009·

    Air Water Channel Cleaning Adapter + Champion 4-piece Valve Kit

    FDA UDI
    GA Health Company Limited·04897106957545·

    Tasso+ Convenience Kit

    FDA UDI
    Tasso Inc.·00850038691042·

    iNAP One

    FDA UDI
    SOMNICS, INC.·04719878320528·R07-B, C07, T01, I07, A03*3, P01

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·June 10, 2020

    SAFE TOUCH NATURAL RUBBER POWDERED LATEX EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    CARESTREAM IMAGE SUITE

    FDA 510(k)
    FDA Class 2 ·Radiology

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·January 5, 2018

    CURRENT PLUS VR

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 9, 2013

    LIBERTY CYCLER SET

    FDA Adverse Event
    Injury ·FRESENIUS MED CARE NORTH AMERICA, REYNOSA MFG·Product code FKX·September 17, 2014

    ACCU-CHEK ® PERFORMA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·May 24, 2011

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code NKB·April 19, 2019

    SMARTXIDE 50 HS

    FDA Adverse Event
    Malfunction ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·October 30, 2023

    GALAXY G3 3MM X 8CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·August 13, 2020

    Integra CUSA excel. CEM Nosecone for CUSA EXcel System. The CEM Nosecone is intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator. Used in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·March 20, 2013

    Siemens Sensis Vibe Hemo system in combination with the MicroPodTM EtCO2 module-diagnostic and administrative tool supporting hemodynamic catheterization and/or electrophysiology studies, for cardiac as well as interventional Radiology.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 9, 2020

    Sensis/ Sensis Vibe systems with software VD1X as follows: (1)Sensis Model 10764561 (2) Sensis Vibe Hemo Model 11007641 (3)Sensis Vibe Combo Model 11007642 Intended Use: A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·November 24, 2021

    TherMax Blood Warmer Unit

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·November 6, 2019