BEUDAMED
    30 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.
    Filters Regulation: Us FDA ×

    SW

    FDA UDI
    SW SAFETY SOLUTIONS INC.·00616489004066·PowerChem Neoprene Exam Gloves, Extra Extra Large

    RHINOSCAN MODEL SRE2000/ SRE2100 WITH ACOUSTIC RHINOMETRY MODULE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    TEWA

    FDA UDI
    asia-med Gesellschaft für Akupunkturbedarf mbH & Co. KG·04251282501662·TeWa 5CB-Type 3025 Speed Pak: coated acupunctu...

    Affiniti

    FDA UDI
    TORNIER, INC.·00846832025251·HUMERAL HEAD TRIAL

    PowerPICC

    FDA UDI
    Bard Access Systems, Inc.·00801741096259·Catheter Placement Kit

    TEWA

    FDA UDI
    asia-med GmbH·04251282508982·TeWa 5CB-Type 3025 Speed Pak: coated acupunctu...

    PROLITE

    FDA UDI
    Atrium Medical Corporation·00650862300062·ProLite Mesh, 4in. x 6in. (10cm x 15cm)

    TruFlex™

    FDA UDI
    Ortho Organizers, Inc.·00190707125585·TRUFLEX NiTi RCS Type 5 Lower 18x25 (10pk)

    TruFlex

    FDA UDI
    ORTHO TECHNOLOGY, INC.·00190730013743·NiTi RCS Type 5 Lower 18x25 10 archwires per pack

    IMMULITE PHENYTOIN, IMMULITE 2000 PHENYTOIN, CATALOG # LKPN1, LKPN5 & L2KPN2, L2KPN6

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    KNIGHT ENDOSCOPIC SPINE SYSTEM (KESS)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AISYS

    FDA Adverse Event
    Malfunction ·DATEX-OHMEDA, INC.·Product code BSZ·January 15, 2016

    ONYX IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·October 8, 2024

    ONYX IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·October 8, 2024

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·March 12, 2013

    TALENT THORACIC STENT GRAFT SYSTEM

    FDA Adverse Event
    Death ·MEDTRONIC CARDIOVASCULAR·Product code MIH·February 18, 2011

    MEDTRONIC PROGRAMMER

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·February 19, 2008

    EVIS EXERA III DUODENOVIDEOSCOPE

    FDA Adverse Event
    Injury ·AIZU OLYMPUS CO., LTD.·Product code FDT·August 17, 2024

    Hard shell carry case for the LIFEPAK 500 AED.

    FDA Recall
    Terminated ·Medtronic Emergency Response Systems, Inc.·Product code MKJ·July 12, 2005

    BrightView SPECT model number 882480 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, and total body studies, as well as circular-orbit and noncircular orbit SPECT studies, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors only).

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 12, 2017