8 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NEXT GENERATION KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PROACTIVE CARE PROPHYLAXIS PASTE WITH FLUORIDE
FDA 510(k)
FDA Class 1
·Dental
TRITIUM STERNAL CABLE PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ENCOR BREAST BIOPSY PROBE
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code KNW·April 3, 2014
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·January 29, 2013
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Death
·ANIMAS CORPORATION·Product code LZG·December 15, 2010
ev3 Pipeline Flex Embolization Device. For neurological endovascular use.
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·April 1, 2020
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015