7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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JEHLE CORONARY PERFUSION CATHETERS
FDA 510(k)
FDA Class 2
·Cardiovascular
TDXR 5-HIAA (URINE)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
EMIT AMITRIPTYLINE/NORTRIPTYLINE CONTROL
FDA 510(k)
FDA Class 1
·Clinical Toxicology
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 19, 2014
ENDO-SOF AQ DOUBLE PIGTAIL STENT SET
FDA Adverse Event
Injury
·COOK UROLOGICAL, INC.·Product code FAD·October 21, 2010
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 4, 2012
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