BEUDAMED
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    SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228; INJECTION SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODEL

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    PowerPICC SOLO

    FDA UDI
    Bard Access Systems, Inc.·00801741096167·Catheter Placement Kit

    TEWA

    FDA UDI
    asia-med Gesellschaft für Akupunkturbedarf mbH & Co. KG·04251282501396·TeWa 5CB-Type 2225 Speed Pak: coated acupunctu...

    TEWA

    FDA UDI
    asia-med GmbH·04251282508715·TeWa 5CB-Type 2225 Speed Pak: coated acupunctu...

    GeneXpert Dx System

    FDA UDI
    CEPHEID·07332940006754·XPERT, GENEXPERT DX SYSTEM

    Eclipse Pro

    FDA UDI
    SPACELABS HEALTHCARE (WASHINGTON), INC·10841522129742·ECLIPSE PRO,DEFIB CABLE,PX,10 SNAP,AHA

    CORTEK CYSTOSCOPE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    GSI 2000 MIDDLE EAR ANALYZER

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/17 MM L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 16, 2020

    TUFF IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·May 29, 2024

    DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code KXT·March 12, 2013

    THYMAPAD STIMULUS ELECTRODES

    FDA Adverse Event
    Malfunction ·SOMATICS, LLC·Product code GXC·February 18, 2011

    PFC SIGMA STAB INS SZ3 10MM

    FDA Adverse Event
    Injury ·DEPUY - RAYNHAM A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code JWH·February 19, 2008

    SMR CEMENTLESS FINNED STEM

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code HSD·July 29, 2021

    8.5" (22 CM) APPX 1.0 ML, EXT SET W/MICROCLAVE CLEAR, CHEMOLOCK PORT, SPIROS

    FDA Adverse Event
    Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code ONB·April 30, 2021

    SMR REVERSE FINNED HUMERAL BODY

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code KWS·February 4, 2022

    ON-Q pump with ONDEMAND bolus button, ON-Q C-bloc with ONDEMAND; ON-Q C-bloc with Select a Flow and ONDEMAND Model/Reference #: 7000180, 7000181, 7000182, 7000367, 7000397, CB003, CB005, CB006, P400X1-7+5/60, P400X2-14+5/30, P400X5+5/60, and PMB01. Part Numbers: 101347100, 101347300, 101347400, 101360200, 101368400, 101368600, 101368700, 102987000, 102987200, 102987300, 103161800, 103534300, 5001438, 5001470, 5001651, 5001780, 5001808, 5001809, 5001812, 7000180, 7000181, 7000182, & 7000367. Indicated for continuous and or intermittent delivery of medication to or around surgical wound sites and or close proximity to nerves.

    FDA Recall
    Terminated ·I-Flow Corporation·Product code MEB·May 8, 2012

    ON-Q pump with ONDEMAND bolus button, ON-Q C-bloc with ONDEMAND; ON-Q C-bloc with Select a Flow and ONDEMAND Model/Reference #: 7000180, 7000181, 7000182, 7000367, 7000397, CB003, CB005, CB006, P400X1-7+5/60, P400X2-14+5/30, P400X5+5/60, and PMB01. Part Numbers: 101347100, 101347300, 101347400, 101360200, 101368400, 101368600, 101368700, 102987000, 102987200, 102987300, 103161800, 103534300, 5001438, 5001470, 5001651, 5001780, 5001808, 5001809, 5001812, 7000180, 7000181, 7000182, & 7000367. Indicated for continuous and or intermittent delivery of medication to or around surgical wound sites and or close proximity to nerves.

    FDA Enforcement
    Class I ·Terminated·I-Flow Corporation·September 5, 2012

    BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143 BrightView SPECT is a gamma camera designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography Emission Computed Tomography (ECT) studies.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 12, 2013

    Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD, Inc.·August 8, 2012