8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACTIVE ANDROSTANEDIOL GLUCURONIDE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SOLARCARE TECHNOLOGIES CORP. MICRO-PLATE PCP ASSAY
FDA 510(k)
FDA Unclassified
·Unknown
SELECTIVE INFUSION II CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
COBAS C 703 ANALYTICAL UNIT
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·May 12, 2026
HUDSON SPIRAL-FLEX REINFORCED ET TUBE
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code BTR·January 23, 2013
INTRACRANIAL PRESSURE / TEMPERATURE MONITORING K
FDA Adverse Event
Malfunction
·INTEGRA NEUROSCIENCES SD·Product code GWM·November 29, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·February 4, 2014
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