BEUDAMED
    16 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 ×

    HOWMEDICA OSTEONICS RADIAL HEAD PROTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ODYSSEY®

    FDA UDI
    Microport Orthopedics Inc.·M684K00143851·

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092001385·artVeneer life lower anteriors, UCS, C3

    Equinoxe

    FDA UDI
    Exactech, Inc.·10885862623867·Humeral Liner Trial, 36mm +0 Right

    CARDIOSAVE HYBRID, TYPE B PLUG

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·March 27, 2025

    Diagon

    FDA UDI
    CAMBER SPINE TECHNOLOGIES, LLC·B030MO0013850·"Off-Set, Bi-Convex, 12mm x 34mm x 15mm, Obliq...

    OPTI-FREE EXPRESS LENS DROPS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MODIFICATION TO ONYX, FINGER CLIP PULSE OXIMETER, MODEL 9500

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    UNKNOWN DEPUY LG POROUS CRUCIFORM PATELLA

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code JWH·March 13, 2013

    SINGLE CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·February 25, 2011

    GE OEC 9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·February 22, 2008

    STERRAD 100NX STERILIZER 1-DR

    FDA Adverse Event
    Malfunction ·ADVANCED STERILIZATION PRODUCTS·Product code MLR·January 6, 2021

    Allura Xper FD20 Biplane; Catalog numbers: (1) 722008, (2) 722013.

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

    Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020