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Clinical Chemistry

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

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RecordFirmDate
MiniMed 670G System (P160017/S026)Medtronic Minimed, Inc.2017-12-21
MiniMed Paradigm Real-Time Revel System (P150019/S033)Medtronic Minimed2017-12-21
FreeStyle Libre Flash Glucose Monitoring System (P160030/S004)Abbott Diabetes Care, Inc.2017-12-21
t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM (P140015/S021)Tandem Diabetes Care, Inc.2017-12-21
MiniMed iPro2 CGM System with Enlite Sensor (P150029/S013)Medtronic Minimed2017-12-21
MiniMed 630G System (P150001/S030)Medtronic Minimed2017-12-21
FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S014)Abbott Diabetes Care, Inc.2017-12-21
MiniMed 530G System (P120010/S107)Medtronic, Inc.2017-12-21
Freestyle Libre Flash Glucose Monitoring System (P160030/S003)Abbott Diabetes Care, Inc.2017-12-20
FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S013)Abbott Diabetes Care, Inc.2017-12-20
MiniMed 630G Insulin Pump (P150001/S028)Medtronic Minimed2017-12-20
Freestyle Libre Flash Glucose Monitoring System (P160030/S001)Abbott Diabetes Care, Inc.2017-12-08
MiniMed 670G System (P160017/S020)Medtronic Minimed, Inc.2017-12-08
Freestyle Libre Flash Glucose Monitoring System (P160030/S002)Abbott Diabetes Care, Inc.2017-11-28
iPro2 Continuous Glucose Monitoring (CGM) System with Enlite Sensor (P150029/S012)Medtronic Minimed2017-11-28
Paradigm Real-Time Revel System (P150001/S027)Medtronic Minimed2017-11-28
MiniMed 530G System (P120010/S106)Medtronic, Inc.2017-11-28
MiniMed 630G System with Enlite Sensor (P150019/S032)Medtronic Minimed2017-11-28
FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S008)Abbott Diabetes Care, Inc.2017-11-16
Dexcom G5 Mobile Continuous Glucose Monitoring System (P120005/S068)Dexcom, Inc.2017-11-14
MiniMed 670G System with SmartGuard (P160017/S024)Medtronic Minimed, Inc.2017-11-07
MiniMed 630G System with SmartGuard (P150001/S026)Medtronic Minimed2017-11-07
Dexcom G4 PLATINUM Continuous Glucose Monitoring System; Dexcom G5 Mobile Continuous Glucose Monitoring System (P120005/S060)Dexcom, Inc.2017-11-03
MiniMed 670G System (P160017/S018)Medtronic Minimed, Inc.2017-10-31
MiniMed 630G System with SmartGuard (P150001/S022)Medtronic Minimed2017-10-31
Animas Vibe System (P130007/S027)Animas Corp.2017-10-27
Minimed 630G Pump (P150001/S025)Medtronic Minimed2017-10-26
MiniMed 670G System (P160017/S023)Medtronic Minimed, Inc.2017-10-26
Animas Vibe System (P130007/S031)Animas Corp.2017-10-24
Guardian Sensor (3) (P160017/S021)Medtronic Minimed, Inc.2017-10-23
Guardian Sensor (3) (P150001/S024)Medtronic Minimed2017-10-23
MiniMed 670G System/ Guardian Sensor (3) (P160017/S016)Medtronic Minimed, Inc.2017-10-16
MiniMed 630G System with SmartGuard / Guardian Sensor (3) (P150001/S020)Medtronic Minimed2017-10-16
Medtronic MiniMed 630G Insulin Pump (P150001/S023)Medtronic Minimed2017-10-11
Medtronic MiniMed 67G Insulin Pump (P160017/S019)Medtronic Minimed, Inc.2017-10-11
MINIMED 530G SYSTEM (P120010/S101)Medtronic, Inc.2017-10-11
Freestyle Libre Flash Glucose Monitoring System (P160030)Abbott Diabetes Care, Inc.2017-09-27
Dexcon G5 Mobile Continuous Glucose Monitoring System (P120005/S065)Dexcom, Inc.2017-09-21
Dexcom G5 Mobile Continuous Glucose Monitoring System (P120005/S066)Dexcom, Inc.2017-09-09
t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM (P140015/S020)Tandem Diabetes Care, Inc.2017-08-25
FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S011)Abbott Diabetes Care, Inc.2017-08-21
Animas Vibe System (P130007/S029)Animas Corp.2017-08-17
MINIMED 630G SYSTEM WITH SMARTGUARD ENLITE SENSOR (P150001/S019)Medtronic Minimed2017-08-16
IPRO2 CGM SYSTEM WITH ENLITE SENSOR (P150029/S011)Medtronic Minimed2017-08-16
PARADIGM REAL-TIME REVEL SYSTEM ENLITE SENSOR (P150019/S031)Medtronic Minimed2017-08-16
MINIMED 530G SYSTEM ENLITE SENSOR (P120010/S105)Medtronic, Inc.2017-08-16
iPro2 Continuous Glucose Monitoring (CGM) System (P980022/S200)Medtronic Minimed2017-08-11
Dexcom G5 Mobile Continuous Glucose Monitoring System (P120005/S064)Dexcom, Inc.2017-08-11
iPro2 Professional Continuous Glucose Monitoring (CGM) System (P150029/S010)Medtronic Minimed2017-08-11
FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S007)Abbott Diabetes Care, Inc.2017-07-28
Freestyle Libre Pro Flash Glucose Monitoring System (P150021/S010)Abbott Diabetes Care, Inc.2017-07-12
Minimed 630G System with Smartguard (P150001/S017)Medtronic Minimed2017-06-29
MiniMed 670G System (P160017/S014)Medtronic Minimed, Inc.2017-06-29
MiniMed 530G System (P120010/S104)Medtronic, Inc.2017-06-23
iPro2 Continuous Glucose Monitoring (CGM) System with Enlite System (P150029/S009)Medtronic Minimed2017-06-23
FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S006)Abbott Diabetes Care, Inc.2017-06-23
Medtronic MiniMed 630G System with Enlite Sensor (P150001/S016)Medtronic Minimed2017-06-23
Paradigm Real Time Revel System (P150019/S030)Medtronic Minimed2017-06-23
G4 Insulin Pump with Dexcom G4 Platinum CGM System (P140015/S022)Tandem Diabetes Care, Inc.2017-06-15
Animas, Vibe System (P130007/S026)Animas Corp.2017-06-09
MiniMed 670G Insulin Pump (P160017/S013)Medtronic Minimed, Inc.2017-06-06
DEXCOM G5 MOBILE CONTIUOUS GLUCOSE MONITORING SYSTEM (P120005/S057)Dexcom, Inc.2017-06-06
Medtronic MiniMed 630G Insulin Pump (P150001/S015)Medtronic Minimed2017-06-06
FREESTYLE LIBRE PRO FLASH GLUCOSE MONITORING SYSTEM (P150021/S001)Abbott Diabetes Care, Inc.2017-06-02
MiniMed 630G System with SmartGuard (P150001/S008)Medtronic Minimed2017-06-02
FREESTYLE LIBRE PRO FLASH GLUCOSE MONITORING SYSTEM (P150021/S004)Abbott Diabetes Care, Inc.2017-05-31
DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM (P120005/S059)Dexcom, Inc.2017-05-22
Dexcom G5 Mobile Continuous Glucose Monitoring System (P120005/S063)Dexcom, Inc.2017-05-10
Paradigm Real-Time Insulin Pump & Paradign Real-Time Revel Insulin Pump (P980022/S199)Medtronic Minimed2017-05-10
MiniMed 530G Insulin Pump (P120010/S103)Medtronic, Inc.2017-05-10
MiniMed 630G Insulin Pump (P150001/S014)Medtronic Minimed2017-05-10
Paradigm REAL-Time Revel Insulin Pump (P150019/S029)Medtronic Minimed2017-05-10
MiniMed 670G Pump (P160017/S012)Medtronic Minimed, Inc.2017-05-10
Dexom G4 PLATINUM Continuous Glucose Monitoring System (P120005/S062)Dexcom, Inc.2017-05-04
Paradigm Real-Time Reveal System (P150019/S028)Medtronic Minimed2017-04-27
MiniMed 630G System With SmartGuard (P150001/S012)Medtronic Minimed2017-04-27
iPro2 CGM System with Enlite Sensor (P150029/S008)Medtronic Minimed2017-04-27
Artificial Pancreas Device System Threshold Suspend (P120010/S102)Medtronic, Inc.2017-04-27
MiniMed 670G System (P160017/S011)Medtronic Minimed, Inc.2017-04-27
FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S005)Abbott Diabetes Care, Inc.2017-04-26
DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM, DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S061)Dexcom, Inc.2017-04-26
Animas Vibe System (P130007/S024)Animas Corp.2017-04-21
Medtronic Minimed 630G System with Enlite (P150001/S011)Medtronic Minimed2017-04-20
Medtronic MiniMed Hybrid Closed Loop (HCL) 670G (P160017/S010)Medtronic Minimed, Inc.2017-04-20
Animas Vibe System (P130007/S023)Animas Corp.2017-04-20
MiniMed 630G System with SmartGuard (P150001/S013)Medtronic Minimed2017-04-14
MINIMED 630G SYSTEM WITH SMARTGUARD (P150001/S009)Medtronic Minimed2017-03-27
IPRO2 CGM SYSTEM WITH ENLITE SENSOR (P150029/S006)Medtronic Minimed2017-03-27
MINIMED 530G SYSTEM (P120010/S100)Medtronic, Inc.2017-03-27
PARADIGM REAL-TIME REVEL SYSTEM (P150019/S027)Medtronic Minimed2017-03-27
T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM (P140015/S017)Tandem Diabetes Care, Inc.2017-03-20
Dexcom G5 Mobile Continuous Glucose Monitoring System (P120005/S050)Dexcom, Inc.2017-03-08
T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM (P140015/S016)Tandem Diabetes Care, Inc.2017-03-06
Guardian Link (3) Transmitter (P160017/S008)Medtronic Minimed, Inc.2017-02-10
T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM (P140015/S019)Tandem Diabetes Care, Inc.2017-02-08
MiniMed 670G System (P160017/S003)Medtronic Minimed, Inc.2017-02-02
PARADIGM REAL-TIME REVEL SYSTEM (P150019/S024)Medtronic Minimed2017-01-25
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S058)Dexcom, Inc.2017-01-19
T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM (P140015/S018)Tandem Diabetes Care, Inc.2017-01-18
FREESTYLE LIBRE PRO FLASH GLUCOSE MONITORING SYSTEM (P150021/S003)Abbott Diabetes Care, Inc.2017-01-12
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