BEUDAMED
    13 results · 40ms · 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 ×

    ClearPoint Maestro Brain Model

    FDA 510(k)
    FDA Class 2 ·Radiology

    Mediflex Modular III Basic Laparoscopic Instruments

    FDA UDI
    FLEXBAR MACHINE CORPORATION·00842102103827·Modular 3 Wave Retention Grasper, Double-Action...

    Mediflex Modular III Basic Laparoscopic Instruments

    FDA UDI
    FLEXBAR MACHINE CORPORATION·00842102103834·Modular 3 DA Wave Retention Grasper,Insert only...

    REGENEROSS ALLOGRAFT PLUS MINERLIZED

    FDA 510(k)
    FDA Class 2 ·Dental

    Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC MACH40

    FDA 510(k)
    FDA Class 2 ·Radiology

    BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code MDB·April 17, 2025

    ACCESS

    FDA Adverse Event
    Malfunction ·BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS·Product code FPA·August 16, 2011

    MICROAIRE

    FDA Adverse Event
    Malfunction ·MICROAIRE SURGICAL INSTRUMENTS·Product code HWC·September 26, 2014

    VITALITY 2

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 9, 2013

    BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code MDB·May 7, 2025

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

    FDA Adverse Event
    Injury ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code JKA·December 3, 2019

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019

    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