BEUDAMED
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    NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180102750·BIPOLAR RF-CABLE WITH DAVOL INSTRUMENT CONNECTO...

    MAYO-LEXER SCISSORS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896055346·MAYO-LEXER SCISSORS STRAIGHT ROUND TUNGSTEN CAR...

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694006958·Template Organizer Block

    CONTEMPRO-MIST

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    OHMEDA MEDICAL GIRAFFE OMNIBED

    FDA 510(k)
    FDA Class 2 ·General Hospital

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE·Product code QFG·November 30, 2022

    DEEP BRAIN STIMULATION DEVICES

    FDA Adverse Event
    Other ·MEDTRONIC NEUROMODULATION·Product code MHY·October 11, 2007

    DRIVE MEDICAL

    FDA Adverse Event
    Injury ·Product code ITJ·October 15, 2008

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·July 1, 2013

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

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