BEUDAMED
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    CardIQ Flow

    FDA 510(k)
    FDA Class 2 ·Radiology

    Model No. 01-1501-0032 (Child Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system commonly referred to as an intramedullary fixation rod (product code HSB). The attachment bolts are one component of the surgical instruments within the system.

    FDA Enforcement
    Class II ·Terminated·OrthoPediatrics Corp·November 6, 2019

    INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

    FDA Adverse Event
    Death ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code MAX·December 18, 2019

    INTERFUSE T INVERTEBRAL BODY FUSION DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B

    FDA 510(k)
    FDA Class 2 ·Microbiology

    BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT

    FDA Adverse Event
    Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·April 12, 2024

    MERGE CARDIO

    FDA Adverse Event
    Malfunction ·MERGE HEALTHCARE SOLUTIONS INC.·Product code LLZ·October 20, 2023

    ACCENT DR RF

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC. CRMD·Product code DXY·January 13, 2014

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    FDA Adverse Event
    Injury ·MEDTRONIC CRYOCATH LP·Product code OAE·June 27, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011

    BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT

    FDA Adverse Event
    Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·April 24, 2024

    BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code PSZ·January 22, 2024

    KIT FLU VERITOR SYSTEM 30 TEST JAPAN

    FDA Adverse Event
    Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·March 1, 2022

    KIT FLU VERITOR SYSTEM 30 TEST JAPAN

    FDA Adverse Event
    Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·March 19, 2021

    KIT FLU VERITOR SYSTEM 30 TEST JAPAN

    FDA Adverse Event
    Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·March 25, 2021