BEUDAMED
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    PHILIPS SP02 DISPOSABLE SENSOR, MODEL M1131A

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809871586·FOR MEN 15-20 MM HG THIGH MICRO DOT BAND CLOSED...

    AART SILICONE TUBING

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    AUDIOSCAN VERIFIT, MODEL VF-1

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

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·November 12, 2014

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·April 3, 2013

    VITALITY DS VR

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008

    ENDOTAK RELIANCE

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVY·April 6, 2011

    Teflon Tube, sterile T2 Humerus System Stryker Trauma GmbH Prof Kuntscher Str 1-5 24232 Sconkidrchen, Germany distributed in the USA by: Stryker Howmedica Osteonics Corp.: Mahwah, NJ 07430 USA 510 K042396 Used in several T2 systems intended to support the exchange of the Ball Tip Guide Wires for Smooth Tip Guide Wires: T2 Tibial Nailing Systems, T2 Femoral Nailing Systems, T2 Ankle Nailing Systems, and T2 Humerus Nailing Systems

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·February 5, 2014

    Roche brand Accu-Chek Aviva Meter (mg/dL); Catalog number 03532275001. (Distributed within the U.S.)

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code LFR·November 9, 2005

    Teflon Tube, sterile T2 Humerus System Stryker Trauma GmbH Prof Kuntscher Str 1-5 24232 Sconkidrchen, Germany distributed in the USA by: Stryker Howmedica Osteonics Corp.: Mahwah, NJ 07430 USA 510 K042396 Used in several T2 systems intended to support the exchange of the Ball Tip Guide Wires for Smooth Tip Guide Wires: T2 Tibial Nailing Systems, T2 Femoral Nailing Systems, T2 Ankle Nailing Systems, and T2 Humerus Nailing Systems

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code HSB·November 7, 2013

    Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018