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

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    CORDIA PAP

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Curette

    FDA UDI
    KATENA PRODUCTS, INC.·00841668102121·SCORSETTI-SHEPHERD POLISHER

    Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    THYROXINE RADIOIMMUNOASSAY KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·May 23, 2014

    UNKNOWN HIP

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS MAHWAH·Product code MEH·November 2, 2012

    PROMOTE PLUS CRT-D

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·September 10, 2010

    PLEURX DRAINAGE KIT 1000ML

    FDA Adverse Event
    Death ·CAREFUSION, INC·Product code DWM·May 9, 2023

    (1) Vanguard Knee System PS Open Box Femoral; Right; 60 mm. Intended for knee joint replacement prostheses. Item Number: 183104 (2) Vanguard Knee System PS Open Box Femoral; Right; 62.5 mm Item Number: 183106 (3) Vanguard Knee System PS Open Box Femoral; Right; 65 mm Item Number: 183108 (4) Vanguard Knee System PS Open Box Femoral; Right; 67.5 mm Item Number: 183110 (5) Vanguard Knee System PS Open Box Femoral; Right; 70 mm Item Number: 183112

    FDA Enforcement
    Class II ·Ongoing·Biomet, Inc.·February 8, 2023

    (1) Vanguard Knee System PS Open Box Femoral; Right; 60 mm. Intended for knee joint replacement prostheses. Item Number: 183104 (2) Vanguard Knee System PS Open Box Femoral; Right; 62.5 mm Item Number: 183106 (3) Vanguard Knee System PS Open Box Femoral; Right; 65 mm Item Number: 183108 (4) Vanguard Knee System PS Open Box Femoral; Right; 67.5 mm Item Number: 183110 (5) Vanguard Knee System PS Open Box Femoral; Right; 70 mm Item Number: 183112

    FDA Recall
    Open, Classified ·Biomet, Inc.·Product code JWH·December 29, 2022

    Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.

    FDA Enforcement
    Class II ·Terminated·STERILMED, INC.·December 16, 2015

    ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025