BEUDAMED
    19 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.

    POLYBONE

    FDA 510(k)
    FDA Class 2 ·Neurology

    Paltop

    FDA UDI
    PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108690323·Titanium Straight Abutment Internal Hex. SP Ø4....

    Paltop

    FDA UDI
    PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108690118·Advanced Dental Implant Ø5mm L8mm

    EVOS Lumbar Interbody System

    FDA UDI
    Cutting Edge Spine, LLC·00841193105017·HA PEEK EVOS Curved, , 12mmx10mmx 26mm , BICONV...

    ANCA Test System

    FDA UDI
    IMMUNO CONCEPTS INC·M74910700121·ANCA BP FA Test System - Formalin Fixed Substra...

    Stent, Carotid

    FDA Pre-Market Approval
    FDA Class 3 ·EXPONENT SELF-EXPANDING CAROTID STENT SYSTEM WITH OVER-THE-WIRE OR RAPID-EXCHANGE DELIVERY SYSTEM

    IMMULITE PHENOBARBITAL, MODELS LKPB1, LKPB5

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    LC PROVIFILL

    FDA 510(k)
    FDA Class 2 ·Dental

    Stent, Carotid

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC VASCULAR EXPONENT SELF-EXPANDING CAROTID SYSTEM

    LINEAR 3-6

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·November 22, 2024

    INTELLIS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·November 4, 2024

    BHR

    FDA Adverse Event
    Injury ·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code NXT·April 22, 2013

    VITROS 5, 1 FS CHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JJE·July 2, 2008

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·April 26, 2011

    ZENITH® TX2® TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT

    FDA Adverse Event
    Injury ·WILLIAM COOK EUROPE·Product code MIH·August 8, 2018

    STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical instruments.

    FDA Enforcement
    Class II ·Terminated·Advanced Sterilization Products·April 10, 2013

    Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.

    FDA Enforcement
    Class I ·Terminated·Animas Corporation·April 10, 2013

    IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec AG·December 9, 2015

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021