BEUDAMED
    17 results · 28ms · Sources: EU EUDAMED, US FDA

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    PHILIPS SURESIGNS CENTRAL

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B16721310320·

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B1672131032060·

    ihcDirect® TPO Ab, 15mL

    FDA UDI
    NOVODIAX, INC.·00850000596856·Clone C129

    ihcDirect® TPO Ab, 5mL

    FDA UDI
    NOVODIAX, INC.·00850000596849·Clone C129

    ihcDirect® TPO Ab Conjugate 5mL

    FDA UDI
    NOVODIAX, INC.·00850030934833·Clone C129

    ihcDirect® TPO Ab Conjugate 15mL

    FDA UDI
    NOVODIAX, INC.·00850030934840·C129

    Fine osteotomy Locking HA 4.5 Cortical Bone Screw - L32mm

    FDA UDI
    Laboratoires Bodycad Inc·00688346002720·Button Head Locking HA 4.5 Cortical Self Tappin...

    VERDICT II, PROFILE II

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    CARDO MEDICAL FEMORAL CEMENT RESTRICTOR, MODEL 503-MCRX

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    8110 ALARIS SYRINGE PUMP

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·November 24, 2020

    BIVONA CUSTOM TTS FLEXTEND TRACHEOSTOMY TUBE

    FDA Adverse Event
    Injury ·SMITHS MEDICAL ASD, INC.·Product code JOH·May 20, 2013

    ATTAIN ABILITY

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code OJX·June 16, 2011

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR - REDWOOD CITY·Product code MGB·August 21, 2008

    Epidural Tray Catalog 1577

    FDA Enforcement
    Class II ·Terminated·Busse Hospital Disposables, Inc.·June 8, 2022

    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

    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