10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LASER BRONCHOSCOPE SYSTEM
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
JOBST Maternity
FDA UDI
BSN MEDICAL, INC.·04042809643411·OPAQUE MATERNITY 15-20 MM HG WAIST HIGH ZIG ZAG...
SwiftNINJA Microcatheter
FDA 510(k)
FDA Class 2
·Cardiovascular
GCS-79
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LIGASURE ATLAS HANDSWITCHING 37CM
FDA Adverse Event
Injury
·COVIDIEN LLC·Product code GEI·February 14, 2014
ENDO ILS, 29MM, CURVED
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·December 7, 2012
MOSAIC AORTIC BIOPROSTHETIC HEART VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES, INC.·Product code LWR·September 30, 2010
MENTOR SILTEX ROUND MODERATE PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·December 26, 2018
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012