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

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    4 SERIES PHOTOTHERAPY UNIT MODEL 4 SERIES

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

    BiPAP A40

    FDA UDI
    Respironics, Inc.·00606959039483·BiPAP A40 Ventilator with Humidifier, Australia

    Surgical Instrument

    FDA UDI
    Jeil Medical Corporation·08806390851152·

    Summa Orthopaedics System Surgical Instrument

    FDA UDI
    Jeil Medical Corporation·08806390867771·

    RDT3 HANDPIECE HEAD MODEL RDT3

    FDA 510(k)
    FDA Class 1 ·Dental

    ARTHREX BIO-TRANSFIX

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 8, 2025

    NEXGEN LCCK FEMORAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·May 8, 2013

    SIG MOD TIB TRAY CEM COCR 4

    FDA Adverse Event
    Injury ·1219655 DEPUY-RAYNHAM·Product code JWH·September 23, 2014

    INTERTAN

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC·Product code HWC·June 2, 2011

    BARREL 3ML LL WWD WITH SIL NO LOGO BNS

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·September 3, 2020

    A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Supporting

    FDA Enforcement
    Class I ·Ongoing·Philips Respironics, Inc.·July 21, 2021

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021

    ACCOLADE DR EL MRI (Model L331)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    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