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Clinical Chemistry

1,179 FDA 510(k) clearances · PMA advisory committee

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RecordFirmDate
G5 Mobile Continuous Glucose Monitoring Systems (P120005/S076)Dexcom, Inc.2018-06-22
EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM (P160048)Senseonics, Incorporated2018-06-21
MiniMed 670G System (P160017/S031)Medtronic Minimed, Inc.2018-06-21
t:slim X2 Insulin Pump with Basal-IQ Technology (P180008)Tandem Diabetes Care, Inc.2018-06-21
Dexcom G4 Platinum/G5 Mobile Continuous Glucose Monitoring System (P120005/S075)Dexcom, Inc.2018-06-15
Dexcom G5 Mobile Continuous Glucose Monitoring System (P120005/S074)Dexcom, Inc.2018-06-13
FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S009)Abbott Diabetes Care, Inc.2018-06-12
Guardian Glucose Sensor (3) (P160007/S003)Medtronic Minimed2018-06-07
Guardian Glucose Sensor (3) (P150001/S044)Medtronic Minimed2018-06-07
Guardian Glucose Sensor (3) (P160017/S042)Medtronic Minimed, Inc.2018-06-07
Freestyle Libre Flash Glucose Monitoring System (P160030/S019)Abbott Diabetes Care, Inc.2018-06-01
FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S028)Abbott Diabetes Care, Inc.2018-06-01
MiniMed 530G Insulin Pump (P120010/S116)Medtronic, Inc.2018-05-30
Paradigm Real-Time Revel Insulin Pump (P150019/S042)Medtronic Minimed2018-05-30
Paradigm Real-Time Insulin Pump, Paradigm Real-Time Revel Insulin Pump (P980022/S204)Medtronic Minimed2018-05-30
Medtronic MiniMed 530G System (P120010/S115)Medtronic, Inc.2018-05-23
Guardian Connect System (P160007/S001)Medtronic Minimed2018-05-23
Medtronic MiniMed iPro2 CGM System with Elite Sensor (P150029/S018)Medtronic Minimed2018-05-23
Medtronic MiniMed 630G System (P150001/S042)Medtronic Minimed2018-05-23
Medtronic MiniMed 670G System (P160017/S040)Medtronic Minimed, Inc.2018-05-23
Medtronic MiniMed Paradigm Real-Time Revel System (P150019/S041)Medtronic Minimed2018-05-23
Dexcom G4 Platinum Continuous Glucose Monitoring System and Dexcom 5 Mobile Continuous Glucose Monitoring System (P120005/S067)Dexcom, Inc.2018-05-07
t:slim X2 Insulin Pump with DexcomG5 Mobile CGM System (P140015/S025)Tandem Diabetes Care, Inc.2018-05-02
FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S026)Abbott Diabetes Care, Inc.2018-04-25
Freestyle Libre Flash Glucose Monitoring System (P160030/S016)Abbott Diabetes Care, Inc.2018-04-25
Guardian Connect System (P160007/S002)Medtronic Minimed2018-04-20
Medtronic MiniMed 670G System (P160017/S041)Medtronic Minimed, Inc.2018-04-20
Medtronic MiniMed 630G System (P150001/S043)Medtronic Minimed2018-04-20
Animas Vibe System (P130007/S035)Animas Corp.2018-04-18
t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM (t:slim G4 system); t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM (P140015/S024)Tandem Diabetes Care, Inc.2018-04-17
FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S025)Abbott Diabetes Care, Inc.2018-04-17
Freestyle Libre Flash Glucose Monitoring System (P160030/S015)Abbott Diabetes Care, Inc.2018-04-17
MiniMed 630G System with SmartGuard (P150001/S041)Medtronic Minimed2018-04-10
Paradigm Real-Time Revel System (P150019/S040)Medtronic Minimed2018-04-10
MiniMed 530G System (P120010/S114)Medtronic, Inc.2018-04-10
iPro2 System (P150029/S017)Medtronic Minimed2018-04-10
MiniMed 670G System (P160017/S039)Medtronic Minimed, Inc.2018-04-10
FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S023)Abbott Diabetes Care, Inc.2018-04-05
Freestyle Libre Flash Glucose Monitoring System (P160030/S013)Abbott Diabetes Care, Inc.2018-04-05
Freestyle Libre Flash Glucose Monitoring System (P160030/S011)Abbott Diabetes Care, Inc.2018-03-29
FreeStyle Libre Pro Flassh Glucose Monitoring System (P150021/S021)Abbott Diabetes Care, Inc.2018-03-29
FreeStyle Libre Flash Glucose Monitoring System (P160030/S012)Abbott Diabetes Care, Inc.2018-03-27
FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S022)Abbott Diabetes Care, Inc.2018-03-27
Dexcom G4 Platinum and G5 Mobile Continuous Glucose Monitoring Systems (P120005/S071)Dexcom, Inc.2018-03-27
MiniMed 630G System (P150001/S040)Medtronic Minimed2018-03-22
MiniMed 670G System (P160017/S038)Medtronic Minimed, Inc.2018-03-22
FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S012)Abbott Diabetes Care, Inc.2018-03-20
Animas Vibe System (P130007/S034)Animas Corp.2018-03-12
iPro System (P150029/S015)Medtronic Minimed2018-03-09
REVEL System with Enlite System (P150019/S038)Medtronic Minimed2018-03-09
MiniMed 670G System (P160017/S036)Medtronic Minimed, Inc.2018-03-09
MiniMed 530G System (P120010/S112)Medtronic, Inc.2018-03-09
MiniMed 630G System (P150001/S038)Medtronic Minimed2018-03-09
Guardian Connect system (P160007)Medtronic Minimed2018-03-08
MiniMed 670G System (P160017/S037)Medtronic Minimed, Inc.2018-03-07
Paradigm Real-Time Revel System (P150019/S039)Medtronic Minimed2018-03-07
MiniMed 630G System with SmartGuard (P150001/S039)Medtronic Minimed2018-03-07
MiniMed 530G System (P120010/S113)Medtronic, Inc.2018-03-07
iPro2 CGM System with Enlite Sensor (P150029/S016)Medtronic Minimed2018-03-07
Medtronic MiniMed 630G System with Guardian Sensor (3) (P150001/S036)Medtronic Minimed2018-03-01
Animas Vibe System (P130007/S033)Animas Corp.2018-03-01
MiniMed 670G System (P160017/S035)Medtronic Minimed, Inc.2018-03-01
Medtronic MiniMed 670G System with Guardian Sensor (3) (P160017/S034)Medtronic Minimed, Inc.2018-03-01
MiniMed 630G System with SmartGuard (P150001/S037)Medtronic Minimed2018-03-01
Paradigm real time Revel Insulin Pump (P980022/S203)Medtronic Minimed2018-02-28
Paradigm real time Revel Insulin Pump (P150019/S037)Medtronic Minimed2018-02-28
MiniMed 530G Insulin Pump (P120010/S111)Medtronic, Inc.2018-02-28
MiniMed 530G Insulin Pump (P120010/S110)Medtronic, Inc.2018-02-28
Paradigm Real Time Revel Insulin Pump (P150019/S036)Medtronic Minimed2018-02-28
Paradigm real time Insulin Pump / Paradigm Real time revel Insulin Pump (P980022/S202)Medtronic Minimed2018-02-28
MiniMed 630G Insulin Pump (P150001/S035)Medtronic Minimed2018-02-28
MiniMed 630G System (P150001/S034)Medtronic Minimed2018-02-28
MiniMed 670G System (P160017/S032)Medtronic Minimed, Inc.2018-02-28
MiniMed 670G System (P160017/S033)Medtronic Minimed, Inc.2018-02-28
Freestyle Libre Flash Glucose Monitoring System (P160030/S007)Abbott Diabetes Care, Inc.2018-02-26
FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S016)Abbott Diabetes Care, Inc.2018-02-26
MiniMed 670G Pump (P160017/S030)Medtronic Minimed, Inc.2018-02-22
MiniMed 630G Pump (P150001/S033)Medtronic Minimed2018-02-22
FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S019)Abbott Diabetes Care, Inc.2018-02-22
FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S018)Abbott Diabetes Care, Inc.2018-02-15
Paradigm REAL-Time Revel System (P150019/S034)Medtronic Minimed2018-02-14
Paradigm REAL-Time Revel System (P980022/S201)Medtronic Minimed2018-02-14
MiniMed 630G System (P150001/S031)Medtronic Minimed2018-02-14
MiniMed 530G System (P120010/S108)Medtronic, Inc.2018-02-14
MiniMed 670G System (P160017/S028)Medtronic Minimed, Inc.2018-02-14
t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM (P140015/S023)Tandem Diabetes Care, Inc.2018-02-14
MiniMed 630G System (P150001/S021)Medtronic Minimed2018-02-13
MiniMed 670G System (P160017/S017)Medtronic Minimed, Inc.2018-02-13
Medtronic MiniMed 670G System (P160017/S029)Medtronic Minimed, Inc.2018-01-19
Medtronic MiniMed Paradigm Real-Time Revel System (P150019/S035)Medtronic Minimed2018-01-19
Medtronic MiniMed 530G System (P120010/S109)Medtronic, Inc.2018-01-19
Medtronic MiniMed 630G System (P150001/S032)Medtronic Minimed2018-01-19
Medtronic MiniMed iPro2 CGM System with Enlite Sensor (P150029/S014)Medtronic Minimed2018-01-19
Dexcon G4 PLATINUM and G5 Mobile Continuous Glucose Monitoring System (P120005/S069)Dexcom, Inc.2018-01-10
MiniMed 670G System (P160017/S027)Medtronic Minimed, Inc.2018-01-03
Freestyle Libre Flash Glucose Monitoring System (P160030/S008)Abbott Diabetes Care, Inc.2017-12-29
FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S017)Abbott Diabetes Care, Inc.2017-12-29
Freestyle Libre Flash Glucose Monitoring System (P160030/S006)Abbott Diabetes Care, Inc.2017-12-28
Freestyle Libre Flash Glucose Monitoring System (P160030/S005)Abbott Diabetes Care, Inc.2017-12-22
FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S015)Abbott Diabetes Care, Inc.2017-12-22
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