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

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    MAC 5000 ECG ANALYSIS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450744901·

    InTess C Cervical Cage System

    FDA UDI
    Kalitec Direct LLC·B07309K01410N0·Cervical Rasp, 15 x 12, 10mm, 0 Degree, No Taper

    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

    InTess C Cervical Cage System

    FDA UDI
    Kalitec Direct LLC·B07309K01410T0·Cervical Rasp, 15 x 12, 10mm, 7 Degree, Tapered

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0144080·Trial, TLIF, 32L OB STR 7Deg, 8mm

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0142080·Trial, TLIF, 32L OB CRV 7Deg, 8mm

    MEDPOR COATED TEAR DRAIN

    FDA 510(k)
    FDA Unclassified ·Unknown

    USS-LINE EXTENSION

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RADIESSE DERMAL FILLER

    FDA Adverse Event
    Injury ·BIOFORM MEDICAL, INC.·Product code LMH·December 8, 2009

    OT VERIO TEST STRIPS

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 21, 2013

    ISOFLEX LEAD

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2011

    EDWARDS GEOFORM MITRAL ANNULOPLASTY RING

    FDA Adverse Event
    Other ·EDWARDS LIFESCIENCES·Product code KRH·March 12, 2008

    VACUETTE BLOOD COLLECTION TUBE 3ML K2E K2EDTA

    FDA Adverse Event
    Malfunction ·GREINER BIO-ONE NA INC.·Product code JKA·November 2, 2020

    UNKNOWN ANKLE TALAR

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code HSN·December 13, 2019

    UNKNOWN ANKLE TIBIAL INSERT

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code HSN·December 13, 2019

    UNKNOWN ANKLE TALAR

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code HSN·December 13, 2019

    Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be used in performing a quantitative, one -stage APTT. The citrate APTT test is used for evaluation of low doses of heparin anticoagulant (up to 1.5 units/mL), depending upon individual patient heparin sensitivity.

    FDA Enforcement
    Class II ·Terminated·ITC-Nexus Dx·February 12, 2014

    Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be used in performing a quantitative, one -stage APTT. The citrate APTT test is used for evaluation of low doses of heparin anticoagulant (up to 1.5 units/mL), depending upon individual patient heparin sensitivity.

    FDA Recall
    Terminated ·ITC-Nexus Dx·Product code GFO·December 19, 2013