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

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    SPECULUM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SMALL BONE BLADES

    FDA UDI
    Peter Brasseler Holdings, LLC·00887919876281·KM33-521

    Brasseler USA

    FDA UDI
    Provision·00810041065001·

    Brasseler USA

    FDA UDI
    Provision·B504OMKM335210·

    Jacobson Micro Coronary Bulldog

    FDA UDI
    KOROS U.S.A., INC.·10840199539717·Jacobson Micro Coronary Bulldog Curved Jaws 21mm

    SeaSpine Spacer System - Ventura

    FDA UDI
    Seaspine Orthopedics Corporation·10889981089207·Ventura Implant/Trial Caddy, 11mm x 32mm, Lordotic

    NA

    FDA UDI
    STERILMED, INC.·10888551007610·SAW BLADE OSCILLATING/SAGITTAL SMALL BONE

    BISBLOCK

    FDA 510(k)
    FDA Class 2 ·Dental

    AZE PHOENIX SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Radiology

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·December 20, 2010

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·January 29, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·July 14, 2014

    OTC Pregnancy Tests. Name: Sure Check hCG Cassette Pregnancy Test. --- Description: the Sure Check hCG Cassette Pregnancy test consists of a lateral flow membrane pad containing anti- hCG monoclonal antibody conjugated to colloidal gold contained in a plastic cassette. It differs from the Sure Check Midstream product in that the lateral flow membrane pad is placed in a cassette and the urine sample is added by pipette rather than by urinating on the absorbent wick. The device is packaged in a foil pouch with desiccant. This product is shipped as bulk packaged product of varying quantities (Catalog # PT127-OTC ordered by Innovative Chemical Co., and Pruebas Moderna Del Istmo; Catalog # PT210 ordered by LABSCO). --- 510(k) K933529/A.

    FDA Recall
    Terminated ·Chembio Diagnostic System Inc·Product code LCX·October 6, 2004

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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