BEUDAMED
    17 results · 24ms · Sources: EU EUDAMED, US FDA

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    GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Unity Total Knee System

    FDA UDI
    CORIN LTD·05056139231568·Femoral / Tibial Augment Screw 5 mm

    Alice 6

    FDA UDI
    Respironics, Inc.·00606959033740·Assembly, Alice 6 Base Station, LDx, China

    JOBST UltraSheer

    FDA UDI
    BSN MEDICAL, INC.·00035664223014·ULTRA SHEER 15-20 MM HG THIGH W/DOT BAND CLOSED...

    ICU Medical

    FDA UDI
    ICU MEDICAL, INC.·00840619043995·TD Catheter, 7F, 4 lumen, 110 cm

    7F TD CATHETER

    FDA Adverse Event
    Malfunction ·ICU MEDICAL, INC.·Product code FPA·April 7, 2015

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172973516·

    MEDIGUIDE TECHNOLOGY

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

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

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

    OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code QFG·February 17, 2026

    LINOX SD 65/18

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

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 26, 2014

    VIRTUOSO DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code LWS·June 13, 2011

    The MSOT Acuity Echo is a Class 4 medical laser device. The MSOT Acuity is a mobile assembly of electrically-powered components intended for imaging and analysis of soft-tissue and vasculature using combined optoacoustic (photoacoustic) and ultrasound (US) imaging.

    FDA Enforcement
    Class II ·Ongoing·Ithera Medical Gmbh·February 19, 2025

    Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025

    Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025