BEUDAMED
    14 results · 27ms · Sources: EU EUDAMED, US FDA

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    Clearblue ® Early Pregnancy Test

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SAS STREPALERT

    FDA 510(k)
    FDA Class 1 ·Microbiology

    ABBOTT ARCHITECT FREE T4

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BASIX COMPAK INFLATION SYRINGE

    FDA Adverse Event
    Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code DXT·June 27, 2011

    CASSETTE MEDI RESERVOIR

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code LHI·March 15, 2022

    CASSETTE MEDI RESERVOIR

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code LHI·February 28, 2022

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 25, 2014

    ASR ACETABULAR CUPS 56

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD.·Product code KWA·August 12, 2011

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 9, 2013

    CADD MEDICATION CASSETTES

    FDA Adverse Event
    Malfunction ·ST PAUL·Product code FPA·April 15, 2022

    CADD MEDICATION CASSETTES

    FDA Adverse Event
    Malfunction ·ST PAUL·Product code FPA·April 15, 2022

    CADD MEDICATION CASSETTES

    FDA Adverse Event
    Malfunction ·ST PAUL·Product code FPA·April 15, 2022

    Philips Zenition 50, Model Number: 718096

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·November 20, 2024

    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