BEUDAMED
    16 results · 24ms · Sources: EU EUDAMED, US FDA

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    3MTM AttestTM Rapid 5 Steam-Plus Test Pack

    FDA 510(k)
    FDA Class 2 ·General Hospital

    METZENBAUM SCISSORS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896055308·METZENBAUM SCISSORS CURVED TUNGSTEN CARBIDE BLA...

    MIXTER FORCEPS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896084872·MIXTER FORCEPS RIGHT ANGLED SERRATED TIP

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180108806·ELMED MONOPOLAR RF-CABLE WITH 3/32" SOCKET PLUG...

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694006903·Cannula, Lag Screw Depth Gauge

    SYNTHES ANTERIOR CSLP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GAZELLE WHEELCHAIR

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    APPLIANCE,FIXATION,SPINAL INTERLAMINAL

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code NKB·September 30, 2015

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 1 L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·May 23, 2024

    PULSE GEN MODEL 103

    FDA Adverse Event
    Injury ·CYBERONICS INC·Product code LYJ·October 24, 2014

    COLLEAGUE PRE P1.7

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

    RESERVOIR 3ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·July 1, 2013

    TI CERVICAL SPINE LOCKING PLATE 45MM (37MM)

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code KWQ·September 9, 2015

    MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product Code 004225 (Suction Coagulator, Handswitching, 8 Fr, 6 inch (15.24cm), Product Code 004325 (Suction Coagulator, Handswitching, 12 Fr, 6 inch (15.24cm)), and Product Code 0041BN (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm), Bulk Non Sterile)

    FDA Enforcement
    Class II ·Ongoing·Megadyne Medical Products, Inc.·August 9, 2023

    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