8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RAICHEM CHOLINESTERASE REAGENT
FDA 510(k)
FDA Class 1
·Clinical Toxicology
DRAGER AV2 ANESTHESIA VENTILATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
CONTRAST DELIVERY SYSTEM - DUAL SHOT ALPHA
FDA 510(k)
FDA Class 2
·Cardiovascular
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·June 10, 2014
INSIGNIA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·October 8, 2010
PRIM SYM SET 2 CL
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·December 5, 2012
D & C Kit, part number CMP1466(A
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
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