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

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    Insufflation Retention Device

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SAFE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ST JUDE MEDICAL, IS4 FLUSHING/FUNNELING TOOL

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RESTORE ADVANCED RECHARGEABLE

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LGW·October 22, 2008

    XENIUM XPH

    FDA Adverse Event
    Injury ·NIPRO CORPORATION *USD*·Product code KDI·August 17, 2011

    NATURAL KNEE II POROUS STEMMED TIBIAL PLATE

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·July 3, 2013

    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