BEUDAMED
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    OSSEOTITE II MODEL XIFOSSXXX

    FDA 510(k)
    FDA Class 2 ·Dental

    SCU Narrow Cap Sampler

    FDA UDI
    ITL ASIA PACIFIC SDN. BHD.·09555240404992·SCU Narrow Cap Sampler is a needleless device u...

    Metalogix Revolution

    FDA UDI
    FUSION ORTHOPEDICS, LLC·00850069061715·Hex Bolt Hinge

    DEBAKEY TANGENTIAL OCCLUSION CLAMP

    FDA UDI
    SONTEC INSTRUMENTS, INC.·B09921007240·DEBAKEY TANGENTIAL OCCLUSION CLAMP DOUBLE ANGLE...

    DEBAKEY TANGENTIAL OCCLUSION CLAMP

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896003163·DEBAKEY TANGENTIAL OCCLUSION CLAMP DOUBLE ANGLE...

    Orthoquest

    FDA UDI
    Young Innovations, Inc.·00840326400319·T Nat D 018X025 Lo

    Young Specialties

    FDA UDI
    Young Innovations, Inc.·00840326425527·NiTi Thermal Archwire, NAT .018x.025 Lower Dimp...

    MEDICA HP 300 HEMOFILTRATION PUMP, MODEL 300

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SOLA 700,SOLA 500, SOLA 300

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

    COCR BALL HEAD 12/14 28 SIZE M 0

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·February 3, 2021

    AMISTEM H FEMORAL STEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·September 26, 2012

    MONTERIS MEDICAL NEUROBLATE SYSTEM

    FDA Adverse Event
    Malfunction ·MONTERIS MEDICAL CORPORATION·Product code GEX·April 22, 2015

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 8, 2013

    2800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 12, 2011

    SERVO GUARD

    FDA Adverse Event
    Malfunction ·MAQUET CRITICAL CARE AB·Product code CAH·April 16, 2008

    LOGIC KNEE COMPONENTS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·December 4, 2025

    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

    IVEA Product Part Number 16100 Model 500A

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