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

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    PATHASSIST LIGHT SEEKER

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    Oticon

    FDA UDI
    Oticon A/S·05707131234933·K50, CIC 10 BE KIT

    Fixion Nailing System

    FDA UDI
    CARBOFIX ORTHOPEDICS LTD·07290109330167·The nail is intended for use in the fixation of...

    Fixion Nailing System

    FDA UDI
    CARBOFIX ORTHOPEDICS LTD·07290109330853·An interlocking intramedullary nail intended fo...

    N/A

    FDA UDI
    HANS RUDOLPH, INC.·00874750003228·75 V2 SMALL 22ID STRGHT W/HG

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776418304·Flexible DA Foreign Body Frcps 10FR 35cm

    Plateau Spacer System

    FDA UDI
    Life Spine, Inc.·00190837045272·Curved Osteotome

    Segmental Plating System

    FDA UDI
    ALPHATEC SPINE, INC.·00190376545479·SPS VA Self-Tap Screw, 3.5 x 22 mm

    Proximity

    FDA UDI
    ALPHATEC SPINE, INC.·00190376694542·PROXIMITY VA SELF-TAP SCREW, 3.5 x 22mm

    SOMATOM P30 CT SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Radiology

    SEDECAL

    FDA 510(k)
    FDA Class 2 ·Radiology

    REVERSE SHOULDER SYSTEM 04.01.0190 THREADED GLENOID BASEPLATE Ø24.5X25

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·February 10, 2023

    HAHN TAPERED IMPLANT Ø3.5 X 8 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·April 24, 2023

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·January 8, 2025

    IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP·Product code LLZ·February 28, 2014

    RESTORE SENSOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 15, 2013

    AVAULTA SOLO ANTERIOR SYNTHETIC SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·C.R. BARD, INC.·Product code FTL·June 1, 2011

    HAHN TAPERED IMPLANT Ø3.5 X 8 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·August 24, 2022

    Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001; V+O+C+S+N+Pro/Japan/PRT-00490-100; V+C+Pro/English/PRT-00900-001; V+C+Pro/Japan/PRT-00900-100; V+C/English/PRT-01098-000; V+O+C+S+N/English/PRT-01100-000; V+O+C+S+N/English/PRT-01100-001;

    FDA Enforcement
    Class II ·Ongoing·Ventec Life Systems, Inc.·June 30, 2021

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021