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

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    LIAISON MeMed BV, LIAISON MeMed BV Control Set

    FDA 510(k)
    FDA Class 2 ·Microbiology

    SILVERLEAF CONTACT WOUND DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    SURGISEAL TOPICAL SKIN ADHESIVE

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

    CLARIUS ULTRASOUND SCANNER

    FDA Adverse Event
    Malfunction ·CLARIUS MOBILE HEALTH CORP.·Product code IYN·October 17, 2024

    PFC OVPAT35MM SM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code NJL·October 27, 2008

    PINNACLE MTL INS NEUT36IDX54OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·August 12, 2011

    HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY

    FDA Adverse Event
    Malfunction ·HEARTWARE, INC.·Product code DSQ·July 9, 2013

    LAPIPLASTY 4.0MM FULLY THREADED SCREW

    FDA Adverse Event
    Injury ·TREACE MEDICAL CONCEPTS, INC.·Product code HWC·March 14, 2025

    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