BEUDAMED
    584 results · 22ms · 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.

    Full Field Digital, System, X-Ray, Mammographic

    FDA Pre-Market Approval
    FDA Class 2 ·FUJI'S COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE (FCRMS)

    Full Field Digital, System, X-Ray, Mammographic

    FDA Pre-Market Approval
    FDA Class 2 ·FUJI COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE

    Full Field Digital, System, X-Ray, Mammographic

    FDA Pre-Market Approval
    FDA Class 2 ·FULL FIELD DIGITAL MAMMOGRAPHY

    PYRAMESH® Implant System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00681490844352·MESH 9050014 PYRAMESH 14MM

    PYRAMESH® Implant System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00763000855932·MESH 9050014 PYRAMESH 14MM

    Pro Advantage

    FDA UDI
    NATIONAL DISTRIBUTION & CONTRACTING, INC.·M220P0800143·Pro Advantage Urinalysis Reagent Strips 4 Param...

    EVOS Lumbar Interbody System

    FDA UDI
    Cutting Edge Spine, LLC·00841193103181·HA PEEK EVOS Curved, , 14mmx9mmx 26mm , FLAT 0 ...

    Ni-Ti - Archwire

    FDA UDI
    ORMCO CORPORATION·00889989025293·PREF ARCH NI-TI UPPER 20 LARGE PK10

    OptiLIF Endo, Direct Visualization System

    FDA UDI
    SPINEOLOGY INC.·M7401050014·Mini A/O Handle

    HEMONIR TM

    FDA 510(k)
    FDA Class 2 ·Hematology

    ZILVER 635 VASCULAR SELF-EXPANDING STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code NIO·July 27, 2022

    ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code NIO·July 23, 2018

    ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code NIO·November 5, 2024

    EndoVive 3s Low Profile Balloon Kits Part Number: M00548330 (XMD P/N 70-0050-014) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.

    FDA Enforcement
    Class II ·Terminated·Xeridiem Mediem Medical Devices Inc·March 2, 2016

    ZILVER 635 VASCULAR SELF-EXPANDING STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code NIO·June 22, 2021

    ZILVER 518 VASCULAR SELF-EXPANDING STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code NIO·June 25, 2021

    ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code NIO·June 16, 2022

    ZILVER 518 VASCULAR SELF-EXPANDING STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code NIO·September 15, 2021

    ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code NIO·February 16, 2021

    Qualitative And Quantitative Hepatitis B Virus Antibody Assays

    FDA Pre-Market Approval
    FDA Class 2 ·VITROS IMMUNODIAGNOSTIC PRODUCTS:ANTI-HBS REAGENT PACK/ANTI-HBS CALIBRATORS