BEUDAMED
    60 results · 18ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    FAST TRACT TRANSTRACHEAL PROCEDURE KIT

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

    N/A

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00613994730046·CASE 6970018 6X18 INSTRUMENTS

    artegral

    FDA UDI
    Merz Dental GmbH·D7091970018·anteriors; shade A1; mould ITS

    Paltop

    FDA UDI
    PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108697377·PAI Dental Implant Ø3.25mm L10mm

    Matching Limb Protection Sleeves for Adaptive Cuffs

    FDA UDI
    Delfi Medical Innovations Inc·M995979700181·Delfi Matching Limb Protection Sleeves (MLPS) h...

    INRATIO2 PT/INR PROFESSIONAL TEST STRIP

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·August 20, 2015

    UNIVERSAL SURGICAL MESH, MODEL 100

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

    StealthStationTM S8 ENT Software

    FDA 510(k)
    FDA Class 2 ·Neurology

    INRATIO2 PT/INR TEST STRIPS

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·July 13, 2015

    NexGen®

    FDA UDI
    Zimmer, Inc.·00889024214200·

    NexGen®

    FDA UDI
    Zimmer, Inc.·00889024214217·

    INRATIO PT/INR TEST STRIPS

    FDA Adverse Event
    Injury ·ALERE SAN DIEGO, INC.·Product code GJS·September 8, 2015

    Processor, Cervical Cytology Slide, Automated

    FDA Pre-Market Approval
    FDA Class 3 ·BD PREPSTAIN SYSTEM

    INRATIO2 PT/INR TEST STRIP

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·March 10, 2016

    CR PRECOAT FEM COMP SIZE BMR CR PRECOAT FEM COMP SIZE C/R CR PRECOAT FEM COMP SIZE D/R CR PRECOAT FEM COMP SIZE E/R CR PRECOAT FEM COMP SIZE F/R CR PRECOAT FEM COMP SIZE G/L CR PRECOAT FEM COMP SIZE H/L CR PRECOAT FEM COMP SIZE H/R CR POROUS FEM COMP SIZE E/L CR POROUS FEM COMP SIZE H/R This device is indicated for patients with severe knee pain and disability

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 21, 2018

    Processor, Cervical Cytology Slide, Automated

    FDA Pre-Market Approval
    FDA Class 3 ·BD PREPSTAIN SYSTEM

    Processor, Cervical Cytology Slide, Automated

    FDA Pre-Market Approval
    FDA Class 3 ·PREPSTAIN (TM) SYSTEM

    Processor, Cervical Cytology Slide, Automated

    FDA Pre-Market Approval
    FDA Class 3 ·PREPSTAIN SYSTEM

    Processor, Cervical Cytology Slide, Automated

    FDA Pre-Market Approval
    FDA Class 3 ·PREPSTAIN SYSTEM

    Processor, Cervical Cytology Slide, Automated

    FDA Pre-Market Approval
    FDA Class 3 ·BD PREPSTAIN SYSTEM