9 results
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25ms
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Sources: EU EUDAMED, US FDA
FISCHER PPS/MAMMOTEST MAMMOGRAPHY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
JOBST Maternity
FDA UDI
BSN MEDICAL, INC.·04042809641592·OPAQUE MATERNITY 20-30 MM HG KNEE HIGH ZIG ZAG ...
Diode Laser Therapy Machine
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RIONET HEARING AID AND/OR RION #HB-70
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
ELITE II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code DXY·October 8, 2010
BRILLIANCE 6 AIR
FDA Adverse Event
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.·Product code JAK·November 28, 2012
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code EZW·June 17, 2015
MEDISLIM
FDA Adverse Event
Injury
·MEDICREATIONS, LLC·Product code GEX·April 27, 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