7 results
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19ms
·
Sources: EU EUDAMED, US FDA
HYGIENIC AIR PURIFYING DEVICE
FDA 510(k)
FDA Class 2
·General Hospital
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses
FDA 510(k)
FDA Class 2
·Ophthalmic
BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SLIMLINE SIS ENDO
FDA Adverse Event
Malfunction
·LUMENIS, LTD.·Product code GEX·May 20, 2014
GOBED II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·November 2, 2012
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 23, 2015
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