8 results
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23ms
·
Sources: EU EUDAMED, US FDA
TOPICAL HYPERBARIC OXYGEN CHAMBER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
JOBST Maternity
FDA UDI
BSN MEDICAL, INC.·04042809640816·OPAQUE MATERNITY 15-20 MM HG KNEE HIGH ZIG ZAG ...
GMI Frontier Dental Implant System
FDA 510(k)
FDA Class 2
·Dental
ATRICURE ISOLATOR TRANSPOLAR PEN SYSTEM, MODELS ASU2, MAX1, MAX2 AND ASB1
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CAPSURE Z
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 10, 2014
ACCURUS 400VS
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·November 28, 2012
ENRHYTHM DR
FDA Adverse Event
MEDTRONIC MED REL, INC.·Product code DXY·October 8, 2010
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