BEUDAMED
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    CAPTIVA SPINE FUSELOX CERVICAL CAGE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Luxatemp® Fluorescence

    FDA UDI
    DMG Chemisch-Pharmazeutische Fabrik GmbH·EDMG1105850·Temporary crown and bridge material automix sys...

    Endo Carry-On Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964105241·Endo Carry-On Procedure Kit

    Custom Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964110849·Custom Procedure Kit

    Trial Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964110832·Trial Procedure Kit

    Endo Carry-On Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964108525·Endo Carry-On Procedure Kit

    Endo Carry-On Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964107924·Endo Carry-On Procedure Kit

    MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    K-Y BRAND LONG LASTING VAGINAL MOISTURIZER

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/17 MM R E-CROSS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·June 13, 2023

    CONTOUR NEXT

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·February 24, 2014

    CONTOUR NEXT

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·May 2, 2013

    TOSHIBA Kalare Diagnostic X-Ray System K110785

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code JAA·April 3, 2013

    SURGILAV PLUS HANDPIECE SET WITH SHOWERHEAD TIP, SOFT CONE SPLASH SHIELD & 10 F

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-PUERTO RICO·Product code FQH·May 14, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 23, 2014

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·June 1, 2011

    TOSHIBA Kalare Diagnostic X-Ray System K110785

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·July 17, 2013

    TomoHDA(R) System, Model Number 1018286 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for t he planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissues. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non- modulated (non-IMRT/3 dimensional conformal) format in accordance with the physicians prescribed and approved plan.

    FDA Enforcement
    Class II ·Terminated·Accuray Incorporated·January 3, 2018

    Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

    EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

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