8 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MICRO ANASTOMOSIS CLAMP
FDA 510(k)
FDA Class 2
·Cardiovascular
EndoEssentials™ Gutta Percha Points ISO#15-40 Asst .02 Taper w MM Markings
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172014816·Polymer-based endodontic gutta percha
HI-LO TEMP GEN. PURPOSE TEMP. PROBE
FDA 510(k)
FDA Class 2
·General Hospital
CORONIS 3MP AND MDCG 3120-CB
FDA 510(k)
FDA Class 2
·Radiology
SENSIA DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·June 10, 2014
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Injury
·ANIMAS CORP.·Product code LZG·October 4, 2010
GOBED II
FDA Adverse Event
Malfunction
·FLEXTRONICS EMS CANADA·Product code FNL·October 31, 2012
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