BEUDAMED
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    Evolve System with the T3 Applicator

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

    VULCAN

    FDA UDI
    Smith & Nephew, Inc.·00885554011951·KIT ITALY

    SIZER FOR STEM DIAMETER 16

    FDA UDI
    FOURNITURES HOSPITALIERES INDUSTRIE·03661489108778·

    MICROMANIPULATOR SET

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

    CHEMWELL, MODEL 2900

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 29, 2014

    MEDISENSE OPTIUM

    FDA Adverse Event
    Malfunction ·Product code NBW·August 12, 2011

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·July 8, 2013

    MEDTRONIC TRANSCATHETER VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·March 15, 2022

    EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·October 7, 2015

    ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 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.·August 5, 2015

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system 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.·August 5, 2015

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·January 22, 2025