13 results
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18ms
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Sources: EU EUDAMED, US FDA
TAN MATE HOME TANNING UNIT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690190738·Porous Knee Instruments Tray
Shoreline ACS
FDA UDI
Seaspine Orthopedics Corporation·10889981285814·Trial 16x12x7mm, 7 Deg Lordosis, w/ Depth Stop
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690190721·Porous Knee Instruments Sterilization Pan Insert
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011861107220·Standard Band, Tooth 44/34, Size 7/Roth 22
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011861107000·Standard Band, Tooth 45-44/34-35, Size 7
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011861107180·Standard Band, Tooth 44/34, Size 7/Roth 18
FOOD GUARDS
FDA 510(k)
FDA Class 1
·Physical Medicine
DPC T60I KUSTI, MODEL 984248; DPC T60I, MODEL 984247
FDA 510(k)
FDA Class 2
·Clinical Chemistry
OPTIFLUX 180NRE DIALYZER FINISHED ASSY.
FDA Adverse Event
Malfunction
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FJI·April 14, 2014
TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code LOX·October 4, 2010
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·December 4, 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