BEUDAMED
    15 results · 36ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    GEMINUS FOSSA SPECIFIC PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Unity Total Knee System

    FDA UDI
    CORIN LTD·05055343897324·Femoral Distal Augment 5 mm sizes 5, 6 & 7

    APEX PS Knee

    FDA UDI
    Omni Life Science, Inc.·00841690113560·PS-C Insert, Size 3 x 10mm

    Baby Gorilla®/Gorilla® Plating System

    FDA UDI
    Paragon 28, Inc.·00889795124418·K Wires, 2.3, 100mm, 67.5mm notched

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K1220100·Breaker, Extended Tab

    ADVANTAGE WINDOWS X-RAY/MR FUSION

    FDA 510(k)
    FDA Class 2 ·Radiology

    WONDFO METHADONE URINE TEST,OPIATE TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    3I T3® TAPERED IMPLANT 4/3 X 11.5MM

    FDA Adverse Event
    Injury ·BIOMET 3I·Product code DZE·May 20, 2025

    122" (310 CM) APPX 3.5 ML, EXT SET, SMALLBORE W/CLAVE¿, LUER LOCK

    FDA Adverse Event
    Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FMG·February 26, 2026

    EQUINOXE REVERSE SHOULDER COMPONENTS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·April 12, 2023

    SETROX S 53

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code NVN·May 21, 2013

    ALLEGRETTO WAVE EYE-Q

    FDA Adverse Event
    Injury ·WAVELIGHT GMBH·Product code LZS·September 18, 2014

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·June 13, 2011

    CERTAS INLINE VLV W/UNTZD CAT

    FDA Adverse Event
    Injury ·CODMAN & SHURTLEFF, INC. / MEDOS S.A.·Product code JXG·January 5, 2018

    I.T.S. Screw System with the below descriptions and corresponding article numbers. 1. Cancellous Screw, Cannulated; Article Numbers: 31404-16, 31404-18, 31404-20, 31404-22, 31404-24, 31404-26, 31404-28, 31404-30, 31404-32, 31404-34, 31404-36, 31404-38, 31404-40, 31404-42, 31404-44, 31404-46, 31404-48, 31404-50, 31404-55, 31404-60, 31404-65, 31404-70, 31404-75, 31404-80, 31457-30, 31457-36, 31457-40, 31457-46, 31457-50, 31457-55, 31457-60, 31652-100, 31652-105, 31652-110, 31652-115, 31652-120, 31652-25, 31652-30, 31652-35, 31652-40, 31652-45, 31652-55, 31652-60, 31652-65, 31652-70, 31652-75, 31652-80, 31652-85, 31652-90, 31652-95, 31731-100, 31731-105, 31731-110, 31731-115, 31731-120, 31731-50, 31731-60, 31731-65, 31731-70, 31731-75, 31731-80, 31731-85, 31731-90, 31731-95, 31732-60, 31734-100, 31734-105, 31734-110, 31734-115, 31734-120, 31734-45, 31734-50, 31734-60, 31734-65, 31734-70, 31734-75, 31734-80, 31734-85, 31734-90, 31734-95. 2. Cortical Screw, Cannulated; Article Numbers: 31357-44, 31357-22, 31357-48, 31277-18, 31357-20, 31357-22, 31357-24, 31357-26, 31357-28, 31357-30, 31357-32, 31357-34, 31357-36, 31357-38, 31357-40, 31357-42, 31357-44, 31357-46, 31357-48, 31357-60, 31357-65, 31357-70. 3. Washer; Article Number: 36851. 4. Washer, Concave; Article Numbers: 36432, 36653, 36732. 5. Washer, Flat; Article Numbers: 36431, 36651, 36653, 36731.

    FDA Enforcement
    Class II ·Ongoing·I.T.S. GmbH·April 1, 2026