BEUDAMED
    21 results · 23ms · Sources: EU EUDAMED, US FDA

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    Bodyport Cardiac Scale

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FAST THERMOMETER MODELS ST713C AND ST713F

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TS IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    OMNIPOD 5 POD

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code QFG·June 1, 2023

    OMNIPOD DASH INSULIN MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·October 3, 2023

    OMNIPOD DASH INSULIN MANAGEMENT SYSTEM

    FDA Adverse Event
    Death ·INSULET CORPORATION·Product code LZG·July 19, 2023

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·October 23, 2008

    COULTER LH 750 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·August 5, 2011

    TELIGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 8, 2013

    OMNIPOD DASH INSULIN MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·December 13, 2023

    I-STAT CG8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code CHL·January 5, 2022

    OMNIPOD DASH, PODS 10-PACK

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·May 9, 2023

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    FDA Adverse Event
    Injury ·INSULET CORPORATION·Product code LZG·January 23, 2024

    OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM

    FDA Adverse Event
    Injury ·INSULET CORPORATION·Product code LZG·July 21, 2022

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code KMW·April 25, 2022

    OMNIPOD 5 POD

    FDA Adverse Event
    Injury ·INSULET CORPORATION·Product code QFG·July 11, 2023

    OMNIPOD DASH INSULIN MANAGEMENT SYSTEM

    FDA Adverse Event
    Injury ·INSULET CORPORATION·Product code LZG·April 17, 2023

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code KMW·July 7, 2022

    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

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system 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.·August 5, 2015