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

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    CORTOSS BONE AUGMENTATION MATERIAL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SchureMed

    FDA UDI
    SCHUERCH CORPORATION·00810014604558·MULTI-AXIS PAD 16" X 6" X 2" CONCAVE DELUX

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306815188·DeBakey Needle Holder, Serrated Jaws, 20cm

    Symmetry Malis®

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482140024·Symmetry® Bipolar Forceps; Bayonet; Straight; T...

    Track A

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR4080108·Track A ø 0,8 x 125 mm

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450179482·

    Maxtown Medical

    FDA UDI
    Modern Surgical Instruments LLC·B419350801080·BP IN K-YASAR 1.3T BAY 7.88

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0101080·Distractor, Smooth Paddle, 8mm

    TiWAVE L Lumbar Cage System

    FDA UDI
    Kalitec Direct LLC·B07323K0101080·Distractor, Smooth Paddle, Lordotic, 8mm

    CUSTOME KIT, CT-SET

    FDA Adverse Event
    Malfunction ·MERIT MEDICAL IRELAND, LTD.·Product code FPA·September 11, 2006

    USS-LINE EXTENSION

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 4, 2025

    VISION HOLLOW FIBER OXYGENATOR

    FDA Adverse Event
    Malfunction ·GISH BIOMEDICAL, INC.·Product code DTZ·February 18, 2011

    NEXGEN LPS FEMORAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code NJL·April 24, 2013

    HEARTSTART MRX-EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·April 6, 2011

    DPS PRESSURE MONITORING KIT W/ ANTI SHUNT

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL·Product code DRS·July 17, 2008

    InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V). Product Usage: The InnerCool RTx device is a thermal regulating system intended to induce, maintain and reverse mild hypothermia, to achieve and/or maintain normothermia, and for use in fever reduction. K080908

    FDA Enforcement
    Class II ·Terminated·Philips Healthcare·February 5, 2014

    HIP END EFFECTOR, VARIABLE ANGLE

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·November 22, 2019

    InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V). Product Usage: The InnerCool RTx device is a thermal regulating system intended to induce, maintain and reverse mild hypothermia, to achieve and/or maintain normothermia, and for use in fever reduction. K080908

    FDA Recall
    Terminated ·Philips Healthcare·Product code NCX·January 13, 2014