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

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    Biotech Dental Kits

    FDA 510(k)
    FDA Class 2 ·General Hospital

    10PW - Hawaiian Telecom

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588120683·10PW - Hawaiian Telecom

    SYNTHES ZERO-P VARIABLE ANGLE (VA)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEONS 1633S, MEONS 1733S

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

    BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·June 18, 2020

    AWL Ø2 ANGL

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code OVE·January 8, 2013

    AWL Ø2 ANGL

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code OVE·January 7, 2013

    AWL Ø2 ANGL

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code OVE·January 7, 2013

    EVOLIS TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL, SA·Product code JWH·February 19, 2010

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPRO

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code LWR·October 23, 2008

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code MDS·July 8, 2011

    PROGRASP FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·July 8, 2013

    MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025