BEUDAMED
    39 results · 20ms · 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.
    Filters Regulation: Us FDA ×

    UMBICUT

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040062333·Endoflex K-Files 25 mm

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·H65810002271·Endoflex K-Files 25 mm

    Custom Procedure Kit

    FDA UDI
    MEDIVATORS INC.·40677964002746·The ENDO CARRY-ON Procedure Kit contains all of...

    PowerPICC SOLO

    FDA UDI
    Bard Access Systems, Inc.·00801741043482·Catheter Placement Kit

    SR Facebow

    FDA UDI
    ORMCO CORPORATION·00889989023251·Facebow SHORT SZ SM .044 DIA.

    CURE IVIEW

    FDA UDI
    MEDITECH SPINE, LLC·B167900002270·

    CURE IVIEW

    FDA UDI
    MEDITECH SPINE, LLC·B167S1900002270·

    INSUFFLATION NEEDLE, MODEL R65-933

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 4001 02-4001 10

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    DAILY ACTIVITY ASSIST DEVICES

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code ILS·March 12, 2013

    SETROX S 60

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG.·Product code NVZ·February 18, 2011

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·ANIMAS CORP.·Product code LZG·February 19, 2008

    SMR CEMENTLESS FINNED STEM 19

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code HSD·December 17, 2020

    HEARTMATE MOBILE POWER UNIT, NA

    FDA Adverse Event
    Malfunction ·THORATEC CORPORATION·Product code DSQ·July 19, 2022

    TT AUGMENTED 360 BASEPLATE #S-R 15°

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code PHX·January 3, 2024

    Single and Dual use Emission Computer Tomography gamma cameras (BrightView XCT, BrightView X & BrightView SPECT) Philips Healthcare Systems, Cleveland, OH. Gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·March 5, 2014

    BrightView XCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015

    2008 MeDS Pump, Venofer(R) Pump Product Usage: The 2008 MeDs pump is an optional accessory for use with the Fresenius 2008 Series Hemodialysis Machines and is intended to administer Venofer to treat iron deficiency anemia in patients with chronic kidney disease undergoing hemodialysis, where Venofer, in conjunction with hemodialysis, is prescribed by a physician.

    FDA Enforcement
    Class II ·Terminated·Fresenius Medical Care Holdings, Inc. dba Renal Solutions·September 4, 2013

    BrightView XCT

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·February 22, 2017