9 results
·
27ms
·
Sources: EU EUDAMED, US FDA
TOTAL PROTEIN PROCEDURE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
JOBST Maternity
FDA UDI
BSN MEDICAL, INC.·04042809641370·OPAQUE MATERNITY 20-30 MM HG KNEE HIGH ZIG ZAG ...
ENDOMEDICAL TECHNOLOGIES QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH FOR OTOLARYNGOSCOPES AND BRONCHOSCOPES
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
sTMS mini
FDA 510(k)
FDA Class 2
·Neurology
REVEAL XT
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code DSI·June 10, 2014
MAXIMO II DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code LWS·October 8, 2010
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·November 29, 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
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021