8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CM-6 TOTAL HIP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
JOBST Maternity
FDA UDI
BSN MEDICAL, INC.·04042809643473·OPAQUE MATERNITY 15-20 MM HG WAIST HIGH ZIG ZAG...
INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNER ACCESSORY
FDA 510(k)
FDA Class 2
·Radiology
IVAC 811Y ELEC. CLINICAL THERMOMETER
FDA 510(k)
FDA Class 2
·General Hospital
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 28, 2014
BIVONA CUSTOM TRACHEOSTOMY TUBE
FDA Adverse Event
Injury
·SMITHS MEDICAL ASD, INC.·Product code JOH·October 4, 2010
GOBED II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·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