BEUDAMED
    21 results · 23ms · Sources: EU EUDAMED, US FDA

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    Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P, HDI-S

    FDA 510(k)
    FDA Class 2 ·Dental

    Release Aid R/W for Mount

    FDA UDI
    BIO CONCEPT Co., Ltd.·06947600304241·

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100172·KRATZ WIRE SPECULUM WITH WINGS

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100271·SAUER INFANT SPECULUM

    Truliant

    FDA UDI
    Exactech, Inc.·10885862523464·PS NOTCH CUTTER, SIZE 6

    ARTHREX TIBIAL GRAFTBOLT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TCS UNBREAKABLE

    FDA 510(k)
    FDA Class 2 ·Dental

    WAVEWRITER ALPHA? 16

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·February 16, 2026

    CART 9733856 S7 STAFF ASSEMBLED 110V

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·June 18, 2019

    CART 9733856 S7 STAFF ASSEMBLED 110V

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·June 6, 2019

    STEALTHSTATION S7 SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code HAW·February 12, 2018

    CART 9734056 S7 STAFF SHRT 100-120V INTL

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·June 18, 2019

    STEALTHSTATION® S7

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·March 18, 2019

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE·Product code KDJ·July 7, 2011

    SELECTSECURE

    FDA Adverse Event
    Injury ·MPRI·Product code NVN·June 8, 2013

    PFC SIGMA MOD TIB TRAY CEM SZ4

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·September 5, 2008

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JKA·September 22, 2023

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JKA·December 4, 2023

    ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012