BEUDAMED
    18 results · 22ms · Sources: EU EUDAMED, US FDA

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    REFLECTION ACETABULAR REINFORCEMENT RINGS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    CONTOUR ACETABULAR RECONSTRUCTION RING

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JDJ·June 6, 2025

    MESH, SURGICAL, ACETABULAR, HIP, PROSTHESIS

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JDJ·January 23, 2026

    US-LITHO

    FDA UDI
    Richard Wolf GmbH·04055207023167·SONOTRODE Ø 4MM WL 360MM straight, reusable

    Sklar Instruments

    FDA UDI
    SKLAR CORPORATION·10649111055089·ECONO STERILE STRABIS SCISS CVD 4.5"STER 50

    CALAVIEW COLORS (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    syngo Application Software

    FDA 510(k)
    FDA Class 2 ·Radiology

    Medical procedure kits labeled as: 1) ECONO STERILE STRABIS SCISS STR 4.5"STER 50, Model Number 96-2540; 2) ECONO STERILE STRABIS SCISS CVD 4.5"STER 50, Model Number 96-2541; 3) ECONO STERILE STRABIS SCISS STR 4.5"STER 25, Model Number 96-2542; 4) ECONO STERILE STRABISMUS SCISS STR4.5"CS/25, Model Number 96-2542M; eye surgery

    FDA Enforcement
    Class II ·Ongoing·Sklar Instruments·January 22, 2025

    SET SCREW (TI-6AL-4V ELI)

    FDA Adverse Event
    Injury ·ALPHATEC SPINE INC·Product code NKB·September 19, 2016

    XENIUM XPM

    FDA Adverse Event
    Malfunction ·NIPRO CORPORATION *USD*·Product code KDI·February 14, 2013

    AUTOMATED PD SET W/CASSETTE4 PRONG

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·January 18, 2011

    INVERSE/REVERSE SCREW SYSTEM, 4.5-30

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code KWS·July 14, 2014

    Depuy P.F.C. E Knee System, all polyethylene posterior-lipped tibial component, Sz 3, 10 mm; Ref 96-2541.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code NJL·May 26, 2005

    BA102

    FDA Adverse Event
    Malfunction ·NAKANISHI INC.·Product code EGS·March 31, 2016

    BA105

    FDA Adverse Event
    Malfunction ·NAKANISHI INC.·Product code EGS·March 28, 2016

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EGS·August 29, 2017

    R-F IM NAIL 10MMDX48CM LG, 11MMDX42CM, 11MMDX44CM, 11MMDX46CM LG, 11MMDX48CM LG, 12MMDX46CM LG, 12MMDX48CM LG, 13MMDX40CM, 13MMDX42CM, 13MMDX44CM, 13MMDX46CM LG, 13MMDX48CM LG, 14MMDX34CM, 14MMDX36CM, 14MMDX38CM, 14MMDX40CM, 14MMDX42CM, 14MMDX44CM, 14MMDX46CM LG, 14MMDX48CM LG

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·June 21, 2017

    Medical procedure kits labeled as: 1) ECONO STERILE STRABIS SCISS STR 4.5"STER 50, Model Number 96-2540; 2) ECONO STERILE STRABIS SCISS CVD 4.5"STER 50, Model Number 96-2541; 3) ECONO STERILE STRABIS SCISS STR 4.5"STER 25, Model Number 96-2542; 4) ECONO STERILE STRABISMUS SCISS STR4.5"CS/25, Model Number 96-2542M; eye surgery

    FDA Recall
    Open, Classified ·Sklar Instruments·Product code HNF·December 3, 2024