BEUDAMED
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    VYCOR SURGICAL ACCESS SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Neurology

    BioQuick®

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR70609731·BioQuick-Brackets Roth .018" 200 Brackets

    DIASCREEN 50 URINE CHEMISTRY ANALYZER, MODEL # 1242-00; DIASCREEN REAGENT STRIP FOR URINALYSIS, CAT. # D11000

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BEHRING COAGULATION SYSTEM (BCS)

    FDA 510(k)
    FDA Class 2 ·Hematology

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HRS·July 25, 2018

    22 G X 0.75 IN. BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·February 13, 2017

    ROD HOLDER

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code LXH·April 16, 2013

    TRUEWAVE TRANSDUCER/VAMP COMBINATION KIT

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DRS·June 12, 2008

    KNIFE

    FDA Adverse Event
    Other ·ALCON PRECISION DEVICE - SINKING SPRING·Product code HNN·April 1, 2011

    Brilliance iCT SP Computed Tomography X-Ray System, 510 (k) #K060937, Model #728311, Serial Numbers: 200005, 200013, and 200047. The recalled system units are equipped with operating software version; 3.2.0.19011. The Brilliance ICT and Brilliance ICT SP are Computed Tomo grapy 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 analysis and display equipment, patient, and equipment supports, components and accessories.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·June 15, 2011

    Brilliance iCT Computed Tomography X-Ray System, 510 (k) #K060937, Model #728306, Serial Numbers: 100019, 100023, 100087, 100103, and 100170. The recalled system units are equipped with operating software version; 3.2.0.19011. The Brilliance ICT and Brilliance ICT SP are Computed Tomo grapy 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 analysis and display equipment, patient, and equipment supports, components and accessories.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·June 15, 2011

    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