BEUDAMED
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    LIQUICHEK D-DIMER CONTROL LEVEL 1, 2 AND 3

    FDA 510(k)
    FDA Class 2 ·Hematology

    Medial Pilon Plate, Right, Medium, 17-Hole

    FDA UDI
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665024678·

    BENCO

    FDA UDI
    BENCO DENTAL SUPPLY CO.·00366975015167·Pedo Mouth Prop Black Box of 2

    InTess L

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

    Battalion

    FDA UDI
    ALPHATEC SPINE, INC.·00840967187525·Battalion, LLIF Trial, 15°, 20 mm Wide, 17 mm X...

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710310320170·Talar Osteotmy Guide, 32mm x 17mm

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710820320170·Zadik Calcaneal Guide, 32mm x 17°

    VARISEED 7.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    RHIGENE MESACUP-2 TEST RNP, MODEL M7741

    FDA 510(k)
    FDA Class 2 ·Immunology

    Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000. Product Usage: Chromophare surgical lights are medical lights for usage in hospital treatment rooms. They provide localized lighting focused on the patient s body for detecting and treating disease, injury, and disability. The surgical lights may only be used in rooms used for medical purposes that have been equipped in accordance with VDE 0100-710 or IEC 60364-7-10 in accordance with the regulations. The Chromophare surgical lights consist of a ceiling tube, SK Box swivel arm support, and a light head. The light head is mounted on a cardanic suspension unit and can be turned, swiveled and tilted in any direction. The spatial repositioning of the light head makes use of the 360 degree rotating swivel/horizontal arm. The 360 degree rotating spring arm is used to adjust the height. The light can be mounted in several configurations, such as a single/dual ceiling mount, a boom-integrated suspension mount, a wall mount, or a mobile roll stand.

    FDA Enforcement
    Class II ·Terminated·Stryker Communications·March 7, 2018

    ACUITY CENTRAL MONITORING

    FDA Adverse Event
    Malfunction ·WELCH ALLYN PROTOCOL, INC.·Product code DSI·March 6, 2013

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC SOMERVILLE·Product code GAM·March 28, 2011

    ORTHO PROVUE

    FDA Adverse Event
    Malfunction ·MICRO TYPING SYSTEMS, INC.·Product code KSZ·April 21, 2008

    UNKNOWN

    FDA Adverse Event
    Injury ·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·April 3, 2017

    Convenience Kits from Centurion that contain an In-Vision- Plus Needleless IV Connector, Model: code RYM5001 InVision-Plus¿ Needless IV Connectors are used for single patient use in IV and blood administration sets without the need for needles, thus eliminating the potential for needle-stick injuries during use.

    FDA Enforcement
    Class II ·Terminated·Centurion Medical Products Corporation·March 2, 2016

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code OYC·November 27, 2017

    NUCLEUS CI24RE (CA) COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE

    FDA Adverse Event
    Injury ·COCHLEAR LTD·Product code MCM·April 3, 2017

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code OYC·May 29, 2017

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code OYC·March 22, 2017

    CONMED HAND CONTROLLED BOVIE

    FDA Adverse Event
    CONMED·Product code GEI·November 29, 2012