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

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    CombiSet Hemodialysis Blood Tubing Set

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

    Medicom Midnight

    FDA UDI
    AMD Medicom Inc·10686864058950·Medicom Midnight - Procedure Earloop Face Masks...

    NICHOLS ADVANTAGE CHEMILUMINESCENCE BIO-INTACT PARATHYROID HORMONE (1-84) IMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    APLIO 500/400/300 V3.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DRS·October 20, 2008

    ENDOPATH STEALTH CIR STAPLER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code KOG·August 17, 2011

    12/14 ARTICUL 44MM M SPEC-2

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. ¿ REG. # 8010379·Product code LPH·July 9, 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