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

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    Air Compression Therapy Device, model: ST-502

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Mediflex Modular III Basic Laparoscopic Instruments

    FDA UDI
    FLEXBAR MACHINE CORPORATION·00842102103865·Modular 3 Wave Grasper, Single-Action,Ratcheted...

    Mediflex Modular III Basic Laparoscopic Instruments

    FDA UDI
    FLEXBAR MACHINE CORPORATION·00842102103872·Modular 3SA Wave Grasper,Insert only,5mmx45cm

    AVOSET INFUSION PUMP ROW

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FRN·March 25, 2025

    AVOSET INFUSION PUMP ROW

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FRN·March 25, 2025

    AURORA Evacuator +Coag

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SP2 FEMORAL LOCKING NAIL, SP2 TIBIAL LOCKING NAIL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AVOSET INFUSION PUMP ROW

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FRN·March 25, 2025

    AVOSET INFUSION PUMP ROW

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FRN·June 22, 2025

    AVOSET INFUSION PUMP ROW

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FRN·December 23, 2025

    AVOSET INFUSION PUMP ROW

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FRN·January 5, 2026

    AVOSET INFUSION PUMP ROW

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FRN·January 5, 2026

    AVOSET INFUSION PUMP ROW

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FRN·April 29, 2026

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2011

    CRE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code KNQ·October 22, 2008

    VITALITY

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

    STPCK Q-SYTE RED 360DEG W/O NUT CAP NS

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMG·October 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