11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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30-CS01, 30-CS02, 30-CS03 CONTROL SYRINGES
FDA 510(k)
FDA Class 2
·General Hospital
Arthrex®
FDA UDI
ARTHREX, INC.·00888867220447·Wedge Inserter, Threaded
LONG NAIL KIT R2.0, TI, LEFT GAMMA3 ?11X400MM X 13
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·December 4, 2012
ULTRA EXTERNAL CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MS-189 MUSCLE STIMULATOR
FDA 510(k)
FDA Class 2
·Physical Medicine
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·June 25, 2014
CXD II
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - LARGO·Product code KDJ·November 10, 2010
ACRYSOF RESTOR
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·December 20, 2012
Alaris PC unit, model 8015, with version 9.12-Keyboard Processor and logic board assembly part number TC10006584. The Alaris PC Unit is the main user interface unit and power supply of the Alaris System, a modular system to be used with Alaris System modules intended for use in todays growing professional healthcare environment for facilities that utilize infusion and/or monitoring devices.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 14, 2013
SmartPath to dStream for 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·November 29, 2023
SmartPath to dStream for 1.5T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781260
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021