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

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    OrthoPulse 2.0E (OPi2E-100)

    FDA 510(k)
    FDA Class 2 ·Dental

    Zavation

    FDA UDI
    Zavation LLC·00197157002893·CIF 14x18, 9 deg, -05

    ALEUTIAN® Interbody Systems

    FDA UDI
    VB Spine LLC·10888857346703·Lordotic Rasp, Size 24x30x17 mm, 10°

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    FDA Adverse Event
    Malfunction ·HAMILTON BONADUZ AG·Product code JTC·November 5, 1999

    MEDAMICUS FLOWGUARD PEELABLE INTRODUCER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HealthMammo

    FDA 510(k)
    FDA Class 2 ·Radiology

    RECONSTRUCTION NAIL R1.5, TI, LEFT T2 RECON ?11X34

    FDA Adverse Event
    Injury ·STRYKER TRAUMA GMBH·Product code HSB·December 19, 2012

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·November 6, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 17, 2013

    ECHOTIP ACUCORE ULTRASOUND BIOPSY NEEDLE

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FCG·May 29, 2024

    ECHOTIP ACUCORE ULTRASOUND BIOPSY NEEDLE

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FCG·October 23, 2024

    ECHOTIP ACUCORE ULTRASOUND BIOPSY NEEDLE

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FCG·March 12, 2024

    TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAP

    FDA Enforcement
    Class II ·Ongoing·TAS Medical Inc·March 12, 2025

    Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 24, 2021

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020