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

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    STRAITH CHIN IMPLANTS

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

    NAR Kit

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209114412·KIT, ROO K9 HANDLER M-FAK w' CG - ODG

    KORONA

    FDA UDI
    HNM TOTAL RECON LLC·00841742100777·KORONA Tri Staple - (L)15mm, 18mmx16mm

    HDR VISION, VISION HDR, HD R/F, UROMAT HD R/F

    FDA 510(k)
    FDA Class 2 ·Radiology

    Seaspine WaveForm C Interbody System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    STAT DL 9.5 FR. 40 CC. IAB

    FDA Adverse Event
    DATASCOPE CORP.·Product code DSP·September 16, 1998

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·May 8, 2014

    MULTI-LUMEN CVC KIT: 2-L 7 FR X 8IN (20 C

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC·Product code DQY·October 17, 2012

    TANDEM T: SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE INC.·Product code LZG·May 27, 2015

    ALINIQ AMS

    FDA Adverse Event
    Malfunction ·ABBOTT SRL·Product code JQP·February 1, 2023

    4.5 BROAD SCP PLT 26-H STER

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·June 21, 2017

    Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·July 22, 2015

    paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

    smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024