BEUDAMED
    40 results · 21ms · Sources: EU EUDAMED, US FDA

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    SYNTHES MATRIX SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Osstell SmartPeg Type 87

    FDA UDI
    Osstell AB·09010522001899·ISQ Measurement Peg

    MAYO RETRACTOR

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896049161·MAYO RETRACTOR

    DEBAKEY COARCTATION CLAMP

    FDA UDI
    SONTEC INSTRUMENTS, INC.·B09921006340·DEBAKEY COARCTATION CLAMP STRAIGHT JAW ANGLED S...

    DEBAKEY COARCTATION CLAMP

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896002883·DEBAKEY COARCTATION CLAMP STRAIGHT JAW ANGLED S...

    Forceps, Needlepulling, TC, Atraumatic 24.0cm tip 2.7mm 6x12 teeth

    FDA UDI
    Geister Medizintechnik GmbH·04057034020999·Forceps, Needlepulling, TC, Atraumatic 24.0cm...

    Monoblock Tibial Trial PS Insert

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215042462·

    HEARTSTREAM XL DEFIBIBRILLATOR/MONITOR, MODEL M4735A, HEARTSTREAM XLT DEFIBRILLATOR/MONITOR.MODEL M2500B

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    ROD TO ROD CROSS BRACES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ELITE+

    FDA Adverse Event
    Injury ·CYNOSURE LLC·Product code GEX·May 1, 2024

    TI-DBLE LEAD CORT 5.0X40MM SCR

    FDA Adverse Event
    Injury ·BIOMET·Product code HSB·March 18, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

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

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 17, 2014

    KNIFE

    FDA Adverse Event
    Malfunction ·ALCON PRECISION DEVICE - SINKING SPRING·Product code HNN·May 13, 2011

    3.5MM INSERTER CONNECTOR LONG

    FDA Adverse Event
    Injury ·BIOMET·Product code LXH·March 18, 2013

    Brilliance iCT Computed Tomography X-ray system, Model 728306

    FDA Enforcement
    Class III ·Terminated·Philips Medical Systems (Cleveland) Inc·November 23, 2016

    Breast Augmentation Pack, part number AMS1786(A Breast Augmentation Pack, part number AMS2790(A Breast Augmentation Pack, part number AMS3324(B Breast Augmentation Pack, part number AMS4382 Breast Augmentation Pack, part number AMS4382(A Breast Augmentation Pack, part number AMS4382(B Breast Augmentation Pack, part number AMS4392 Breast Augmentation Pack, part number PSS3430

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017

    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