BEUDAMED
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    InTess L

    FDA UDI
    Kalitec Direct LLC·B07312K0310170·T-Handle, Fixed, 1/4" Square

    SYS*STIM 208 AND 208A

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Cetro America Ultrasound Transducer for Corometrics 115 & 145

    FDA UDI
    CETRO AMERICA INC·00852519007076·Ultrasound Transducer for Corometrics 115 & 145...

    Kelly Tenaculum 4X5 Teeth 9" (229mm)

    FDA UDI
    MEDGYN PRODUCTS, INC.·M803031017·Kelly Tenaculum 4X5 Teeth 9" (229mm)

    Medial Pilon Plate, Left, Medium, 17-Hole

    FDA UDI
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665024647·

    PROMAX-XP, TENS AND MICROCURRENT DEVICE; PROMAX-TENS, TENS DEVICE; PROMAX-LIBRA, TENS DEVICE; PROMAX-MC, MICROCURRENT

    FDA 510(k)
    FDA Class 2 ·Neurology

    RETRAX RETRACTING NEEDLE SYRINGE, SIZE 3CC

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NITINOL TC ELECTRODE

    FDA Adverse Event
    Malfunction ·COSMAN MEDICAL·Product code GXI·October 3, 2017

    NITINOL TC ELECTRODE

    FDA Adverse Event
    Malfunction ·COSMAN MEDICAL·Product code GXI·August 23, 2017

    CS300

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·March 28, 2013

    PARADIGM INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code LZG·March 16, 2011

    GE OEC 9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·April 17, 2008

    9.0MM MEDULLARY REAMER HEAD

    FDA Adverse Event
    Injury ·SYNTHES SELZACH·Product code HTO·July 15, 2015

    5.0MM FLEXIBLE SHAFT

    FDA Adverse Event
    Injury ·SYNTHES BETTLACH·Product code HTO·July 15, 2015

    InnoWave Sonic Irrigator, There are currently six models (PCF, Pro, Ultra, Ultra+, Unity, and ECO) - Product Usage: STERIS InnoWave Sonic Irrigators are intended to thoroughly clean (remove tissue, blood, and other contaminants from) a variety of reusable surgical instruments. The equipment provides sonic irrigation (ultrasonic cavitation) to both interior and exterior of lumened instruments.

    FDA Enforcement
    Class II ·Terminated·Steris Corporation·August 5, 2020

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018