BEUDAMED
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    VERASENSE for Stryker Triathlon

    FDA 510(k)
    FDA Class 2 ·Neurology

    2006 65

    Device
    EU MDR · Eu Md Class 1 ·VOE , S.A·On the market

    DESS dental smart solutions

    FDA UDI
    TERRATS MEDICAL SL.·08435457233763·Tri-lobe

    Endo Carry-On Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964075087·Endo Carry-on Procedure Kit includes Enzymatic ...

    Apelo® / Apelo® MIS

    FDA UDI
    ATLAS SPINE, INC.·M68120066500000·Rod Pusher

    TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HI-OX

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·October 17, 2008

    ADVANTAGE SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 1, 2013

    SYNVISC

    FDA Adverse Event
    *·Product code MOZ·October 20, 2006

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014

    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

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021