BEUDAMED
    19 results · 22ms · Sources: EU EUDAMED, US FDA

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    DX-D IMAGING PACKAGE

    FDA 510(k)
    FDA Class 2 ·Radiology

    Tasso+ Convenience Kit

    FDA UDI
    Tasso Inc.·00860006434588·Tasso+ convenience kit allows self-collection o...

    ZEVO ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWQ·October 23, 2019

    N/A

    FDA UDI
    TETRA MEDICAL SUPPLY CORP.·00614138124783·GAIT BELT W/BUCKLE 2 X 48

    3M™ Unitek™

    FDA UDI
    3M UNITEK CORPORATION·00652221037633·Unitek(TM) Bicuspid Band General Purpose Narrow...

    ZEVO ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWQ·December 19, 2018

    Life Instruments

    FDA UDI
    Life Instrument Corporation·M93071416022D0·Custom Bayonet Curette #2 Rev. Ang. Dwn 6" handle

    Life Instruments

    FDA UDI
    Life Instrument Corporation·M93071416021D0·Bayonet Cup Curette Ang Dwn 10" WL, 5" handle

    Life Instruments

    FDA UDI
    Life Instrument Corporation·M93071416021U0·Custom Bayonet curette #2, Ang. Up 6" handle

    Life Instruments

    FDA UDI
    Life Instrument Corporation·M93071416020U0·Custom Bayonet Curette #2, Str, Up, 6" handle

    NYOrtho Wheelchair Cushion Gel-Foam 14x16x2

    FDA UDI
    N.Y. ORTHOPEDIC USA, INC.·00810114600238·NYOrtho Gel-Foam Cushions combine a dual chambe...

    PANORAMA 1.0T

    FDA 510(k)
    FDA Class 2 ·Radiology

    VITAL SIGNS MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PORT

    FDA Adverse Event
    Injury ·PFM MEDICAL CPP SA·Product code LJT·December 17, 2025

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013

    L9000 LIGHTSOURCE

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY SAN JOSE·Product code FCW·May 31, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 4, 2014

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018