8 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Inqwire Diagnostic Guide Wire
FDA 510(k)
FDA Class 2
·Cardiovascular
SPIRO PD
FDA 510(k)
FDA Class 2
·Anesthesiology
HILLA DIGITAL TRANSFERS
FDA 510(k)
FDA Class 2
·Dental
NAIL HOLDING SCREW, TIBIA 10 MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·March 2, 2012
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 10, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·June 11, 2013
PONTO IMPLANT 4MM WITH ABUTMENT 6MM
FDA Adverse Event
Other
·OTICON MEDICAL AB·Product code LXB·March 18, 2011
Applied Medicals Epix¿ and Direct Drive Laparoscopic Graspers, Model Numbers C4130 and C4140. Used for grasping and manipulating tissue during general or laparoscopic surgery.
FDA Enforcement
Class II
·Terminated·Applied Medical Resources Corp·June 19, 2013