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Clinical Chemistry

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

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RecordFirmDate
Flash Glucose Monitoring System (P150021/S035)Abbott Diabetes Care, Inc.2018-12-21
Freestyle Libre Pro (P160030/S027)Abbott Diabetes Care, Inc.2018-12-21
Paradigm Real-Time Revel System with Enlite Sensor (P150019/S014)Medtronic Minimed2018-12-21
MiniMed 530G System (P120010/S089)Medtronic, Inc.2018-12-20
MiniMed 530G System (P120010/S126)Medtronic, Inc.2018-12-07
MiniMed 630G System (P150001/S056)Medtronic Minimed2018-12-07
Eversense Continuous Glucose Monitoring System (P160048/S005)Senseonics, Incorporated2018-12-07
MiniMed iPro2 CGM System with Enlite Sensor (P150029/S025)Medtronic Minimed2018-12-07
Paradigm Real-Time Revel System (P150019/S052)Medtronic Minimed2018-12-07
Paradigm REAL-Time Revel Insulin Pump (P150019/S050)Medtronic Minimed2018-12-07
Paradigm REAL-Time Insulin Pump (P980022/S207)Medtronic Minimed2018-12-07
Minimed 530G Insulin Pump (P120010/S124)Medtronic, Inc.2018-12-07
Eversense Continuous Glucose Monitoring System (P160048/S004)Senseonics, Incorporated2018-12-06
Dexcom G5 Platinum Contiuous Glucose Monitoring System (P120005/S079)Dexcom, Inc.2018-12-04
Paradigm Real-Time Revel System (P150019/S051)Medtronic Minimed2018-11-30
iPro2 CGM System with Enlite Sensor (P150029/S024)Medtronic Minimed2018-11-30
MiniMed 630G System with SmartGuard (P150001/S055)Medtronic Minimed2018-11-30
MiniMed 530G System (P120010/S125)Medtronic, Inc.2018-11-30
MiniMed 630G System (P150001/S054)Medtronic Minimed2018-11-30
MiniMed Paradigm Real-Time Revel System (P150019/S049)Medtronic Minimed2018-11-30
MiniMed iPro2 CGM System with Enlite Sensor (P150029/S023)Medtronic Minimed2018-11-30
MiniMed 670G System (P160017/S053)Medtronic Minimed, Inc.2018-11-30
MiniMed 530G System (P120010/S123)Medtronic, Inc.2018-11-30
Guardian Connect System (P160007/S011)Medtronic Minimed2018-11-30
t:slim X2 Insulin Pump with Basal-IQ Technology (P180008/S002)Tandem Diabetes Care, Inc.2018-11-29
MiniMed 630G System with SmartGuard (P150001/S052)Medtronic Minimed2018-11-29
t:slim X2 Insulin Pump with Basal-IQ Technology (P180008/S003)Tandem Diabetes Care, Inc.2018-11-29
t:slim X2 Insulin Pump with Basal-IQ Technology (P180008/S001)Tandem Diabetes Care, Inc.2018-11-29
MiniMed 670G System (P160017/S051)Medtronic Minimed, Inc.2018-11-29
MiniMed 670G Insulin Pump Guardian Link (3) Transmitter (P160017/S048)Medtronic Minimed, Inc.2018-11-20
MiniMed 630G Insulin Pump, Guardian Link (3) Transmitter (P150001/S050)Medtronic Minimed2018-11-20
Guardian Connect System (P160007/S010)Medtronic Minimed2018-11-14
Paradigm Real-Time Revel System (P150019/S048)Medtronic Minimed2018-11-14
MiniMed 670G System (P160017/S052)Medtronic Minimed, Inc.2018-11-14
Minimed 530G System (P120010/S122)Medtronic, Inc.2018-11-14
iPro2 CGM System with Enlite Sensor (P150029/S022)Medtronic Minimed2018-11-14
Minimed 630G System with Smartguard (P150001/S053)Medtronic Minimed2018-11-14
Eversense Continuous Glucose Monitoring System (CGMS-Entire System), Eversense Sensor, Eversense Insertion Tools, Everse (P160048/S002)Senseonics, Incorporated2018-11-06
Paradigm REAL-Time Revel Insulin Pump (P150019/S047)Medtronic Minimed2018-11-02
MiniMed 530G Insulin Pump (P120010/S121)Medtronic, Inc.2018-11-02
Paradigm REAL-Time Insulin Pump (P980022/S206)Medtronic Minimed2018-11-02
Freestyle Libre Flash Glucose Monitoring System; FreeStyle Libre 14 Day Flash Glucose Monitoring System (P160030/S010)Abbott Diabetes Care, Inc.2018-10-31
t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM (P140015/S027)Tandem Diabetes Care, Inc.2018-10-26
t:slim X2 Insulin Pump with Basal-IQ Technology (P180008/S006)Tandem Diabetes Care, Inc.2018-10-26
t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM (P140015/S026)Tandem Diabetes Care, Inc.2018-10-11
t:slim X2 Insulin Pump with Basal-IQ Technology (P180008/S005)Tandem Diabetes Care, Inc.2018-10-11
G5 Mobile Continuous Glucose Monitoring System (P120005/S077)Dexcom, Inc.2018-10-11
G4 PLATINUM Continuous Glucose Monitoring System and G5 Mobile Continuous Glucose Monitoring System (P120005/S078)Dexcom, Inc.2018-10-04
FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S034)Abbott Diabetes Care, Inc.2018-09-27
Freestyle Libre 14 Day Flash Glucose Monitoring System (P160030/S025)Abbott Diabetes Care, Inc.2018-09-25
Freestyle Libre Pro Flash Glucose Monitoring System (P150021/S033)Abbott Diabetes Care, Inc.2018-09-19
Freestyle Libre Flash Glucose Monitoring System (P160030/S026)Abbott Diabetes Care, Inc.2018-09-19
Eversense Continuous Glucose Monitoring System (P160048/S001)Senseonics, Incorporated2018-09-18
MiniMed 670G System (P160017/S050)Medtronic Minimed, Inc.2018-08-31
FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S032)Abbott Diabetes Care, Inc.2018-08-22
Freestyle Libre Flash Glucose Monitoring System (P160030/S024)Abbott Diabetes Care, Inc.2018-08-22
Guardian Sensor (3) (P160007/S004)Medtronic Minimed2018-08-16
MiniMed 630G System with SmartGuard (P150001/S051)Medtronic Minimed2018-08-14
MiniMed 670G System (P160017/S049)Medtronic Minimed, Inc.2018-08-14
Paradigm REAL-Time Insulin Pump, Paradigm REAL-Time Revel Insulin Pump (P980022/S205)Medtronic Minimed2018-08-14
Paradigm REAL-Time Revel Insulin Pump (P150019/S046)Medtronic Minimed2018-08-14
MiniMed 530G Insulin Pump (P120010/S120)Medtronic, Inc.2018-08-14
MiniMed 530G System (P120010/S119)Medtronic, Inc.2018-08-06
MiniMed Paradigm Real-Time Revel System (P150019/S045)Medtronic Minimed2018-08-06
MiniMed 630G System with SmartGuard (P150001/S049)Medtronic Minimed2018-08-06
Guardian Connect System (P160007/S009)Medtronic Minimed2018-08-06
MiniMed iPro2 CGM System with Enlite Sensor (P150029/S021)Medtronic Minimed2018-08-06
MiniMed 670G System (P160017/S047)Medtronic Minimed, Inc.2018-08-06
Medtronic MiniMed 670G System / Giardian Senor (3) (P160017/S046)Medtronic Minimed, Inc.2018-08-03
Medtronic MiniMed 630G System with Guardian Sensor (3)/ Guardian Sensor (3) (P150001/S048)Medtronic Minimed2018-08-03
Guardian Connect system / Guardian Sensor (3) (P160007/S008)Medtronic Minimed2018-08-03
FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S027)Abbott Diabetes Care, Inc.2018-07-27
FreeStyle Libre Flash Glucose Monitoring System (P160030/S018)Abbott Diabetes Care, Inc.2018-07-27
Freestyle Libre Pro Flash Glucose Monitoring System (P150021/S024)Abbott Diabetes Care, Inc.2018-07-23
FreeStyle Libre 14 Day Flash Glucose Monitoring System (P160030/S017)Abbott Diabetes Care, Inc.2018-07-23
Freestyle Libre Flash Glucose Monitoring System (P160030/S014)Abbott Diabetes Care, Inc.2018-07-23
MiniMed iPro2 CGM System with Enlite Sensor (P150029/S020)Medtronic Minimed2018-07-16
MiniMed 530G System (P120010/S118)Medtronic, Inc.2018-07-16
Guardian Connect system (P160007/S007)Medtronic Minimed2018-07-16
MiniMed 630G System (P150001/S047)Medtronic Minimed2018-07-16
MiniMed 670G System (P160017/S045)Medtronic Minimed, Inc.2018-07-16
MiniMed Paradigm Real-Time Revel System (P150019/S044)Medtronic Minimed2018-07-16
13 C-SPIRULINA GASTRIC EMPTYING BREATH TEST (GEBT) (P110015/S004)Advanced Breath Diagnostics2018-07-12
Animas Vibe System (P130007/S036)Animas Corp.2018-07-11
FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S030)Abbott Diabetes Care, Inc.2018-07-06
FreeStyle Libre Flash Glucose Monitoring System (P160030/S022)Abbott Diabetes Care, Inc.2018-07-06
FreeStyle Libre Flash Glucose Monitoring System (P160030/S023)Abbott Diabetes Care, Inc.2018-07-03
G5 Mobile transmitter Hardware and Firmware, G5 Mobile Continuous Glucose Monitoring System (P120005/S073)Dexcom, Inc.2018-07-03
FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S031)Abbott Diabetes Care, Inc.2018-07-03
MiniMed 670G System Pump (P160017/S043)Medtronic Minimed, Inc.2018-07-02
MiniMed 630G Insulin Pump (P150001/S045)Medtronic Minimed2018-07-02
Freestyle Libre Flash Glucose Monitoring System (P160030/S020)Abbott Diabetes Care, Inc.2018-06-28
Guardian Connect System (P160007/S006)Medtronic Minimed2018-06-28
MiniMed 670G System (P160017/S044)Medtronic Minimed, Inc.2018-06-28
MiniMed 530G System (P120010/S117)Medtronic, Inc.2018-06-28
FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S029)Abbott Diabetes Care, Inc.2018-06-28
Paradigm Real-Time Revel System (P150019/S043)Medtronic Minimed2018-06-28
MiniMed iPro2 CGM System with Enlite Sensor (P150029/S019)Medtronic Minimed2018-06-28
MiniMed 630G System with SmartGuard (P150001/S046)Medtronic Minimed2018-06-28
Guardian Sensor (3) System (P160007/S005)Medtronic Minimed2018-06-26
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