BEUDAMED
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    Vitrea CT Dual Energy Image View

    FDA 510(k)
    FDA Class 2 ·Radiology

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111309281·S E OPER SCISS 51/2 CVD B/B TC

    5161157

    FDA Adverse Event
    Malfunction ·October 20, 2015

    E-BASIC SINGLE BREAST PUMP

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

    SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code LZG·May 25, 2017

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·October 22, 2012

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 10, 2014

    OT PING METER

    FDA Adverse Event
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013

    UNKNOWN ACETABULAR CUP

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS MAHWAH·Product code KWB·July 8, 2011

    I-STAT TROPONIN (CTNI) CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code MMI·August 4, 2017

    BELLAFILL DERMAL FILLER (PREVIOUSLY KNOWN AS ARTEFILL DERMAL FILLER)

    FDA Adverse Event
    Injury ·SUNEVA MEDICAL, INC.·Product code LMH·October 25, 2019

    Charnley PN Retract & Handle, REF 962004000, Non-Sterile-DuPuy International Ltd. The Charnley Pin Retractor and Handle Set is used to facilitate the insertion and extraction of two pins into and out of bone in the incision area, thereby holding the incision soft tissue open during the surgical procedure.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·October 15, 2014

    Brilliance 64 Model # 728231, computed tomography x-ray system

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·August 14, 2019

    Brilliance 64, Model 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·December 12, 2018

    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