BEUDAMED
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    PLASMALUXLS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    HEART™

    FDA UDI
    SUNMED, LLC·10889483223758·HEART™ Direct Connect Continuous Nebulizer, Sup...

    GEN4 DIGITAL

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828112376·GEN4 DIGITAL

    DEBAKEY COARCTATION CLAMP

    FDA UDI
    SONTEC INSTRUMENTS, INC.·B09921006280·DEBAKEY COARCTATION CLAMP SLIGHT SPOON JAW

    GELPI RETRACTOR

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896048669·GELPI RETRACTOR HEAVY TIPS

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450804247·

    Forceps, Needlepulling, TC, Atraumatic 24.0cm tip 2.0mm 2x4 teeth

    FDA UDI
    Geister Medizintechnik GmbH·04057034020937·Forceps, Needlepulling, TC, Atraumatic 24.0cm...

    WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633; WALLACE OOCYTE RETRIEVAL SET-17G, MODEL MEONS1733

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

    POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    REDUCTION FORCEPS WITH SERRATED JAW 240MM-SPEED LOCK

    FDA Adverse Event
    Malfunction ·SYNTHES TUTTLINGEN·Product code HTD·January 31, 2017

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·May 8, 2013

    DISCOVISC

    FDA Adverse Event
    Malfunction ·ALCON-BELGIUM/S.A. ALCON-COUVREUR N.V.·Product code LZP·May 13, 2011

    STORZ CUTTING LOOP

    FDA Adverse Event
    Injury ·KARL STORZ ENDOSCOPY AMERICA INC.·Product code FAS·August 6, 2008

    Brilliance iCT Computed Tomography X-ray system

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·December 30, 2015

    Brilliance iCT 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

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 20, 2016

    Brilliance iCT - Model no. 728306 Computed Tomography X-Ray system 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·April 25, 2018

    Brilliance iCT, Model No. 728306; To produce cross-sectional images of the body.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·August 17, 2016

    Brilliance iCT - Model 728306 Computed Tomography X-ray systems

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·January 31, 2018

    HA FlexTrak II-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710008732

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·June 12, 2024

    IVEA Product Part Number 16100 Model 500A

    FDA Enforcement
    Class II ·Terminated·Firefly Medical, Inc.·October 11, 2017