7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Magic Clear Aligners
FDA 510(k)
FDA Class 2
·Dental
HYPO CLENZ WOUND WASH MODEL 100 PPM
FDA 510(k)
FDA Unclassified
·Unknown
HEALTH CARE SYSTEM SOFTWARE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 21, 2014
6000CMS
FDA Adverse Event
Malfunction
·MOOG DEVICE GROUP·Product code FRN·June 14, 2013
ENDEAVOR SPRINT RX CORONARY SPRINT RX
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIQ·July 28, 2011
Natural-Knee System Patella Bushings Orthopedic surgical instrument. Part Number: 6290-00-703. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella and used as a guide for the matching size patella cutter.
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·September 10, 2014