8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Reprocessed Supreme Diagnostic Electrophysiology Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM
FDA 510(k)
FDA Class 3
·Obstetrics/Gynecology
INREACH PLANNING LAPTOP
FDA 510(k)
FDA Class 2
·Radiology
BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·April 5, 2023
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 10, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 28, 2011
SUREFIRE SCORPION NEEDLE
FDA Adverse Event
Other
·ARTHREX, INC.·Product code MDM·September 30, 2008
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