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Clinical Chemistry

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

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RecordFirmDate
Medtronic MiniMed 670G insulin pump, Medtronic MiniMed 770G insulin pump (P160017/S098)Medtronic Minimed, Inc.2022-04-28
Freestyle Libre 14-Day Flash Glucose Monitoring System (P160030/S050)Abbott Diabetes Care, Inc.2022-03-16
FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S056)Abbott Diabetes Care, Inc.2022-03-16
FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S055)Abbott Diabetes Care, Inc.2022-03-02
Freestyle Libre 14-Day Flash Glucose Monitoring System (P160030/S049)Abbott Diabetes Care, Inc.2022-03-02
Eversense® E3 Continuous Glucose Monitoring System (P160048/S016)Senseonics, Incorporated2022-02-10
Dexcom G5 Mobile Continuous Glucose Monitoring System (P120005/S088)Dexcom, Inc.2022-01-20
Freestyle Libre 14 day Flash Glucose Monitoring System (P160030/S048)Abbott Diabetes Care, Inc.2022-01-19
G5 Mobile Continuous Glucose Monitoring System (P120005/S089)Dexcom, Inc.2021-12-21
MiniMed™ 530G System (P120010/S140)Medtronic, Inc.2021-12-17
iPro™ 2 CGM System with Enlite™ Glucose Sensor (P150029/S037)Medtronic Minimed2021-12-17
Guardian™ Connect system (P160007/S042)Medtronic Minimed2021-12-17
Paradigm™ Real-Time Revel™ System (P150019/S064)Medtronic Minimed2021-12-17
MiniMed™ 670G System (P160017/S095)Medtronic Minimed, Inc.2021-12-17
MiniMed™ 630G System with SmartGuard™ (P150001/S093)Medtronic Minimed2021-12-17
Freestyle Libre 14-Day Flash Glucose Monitoring System (P160030/S044)Abbott Diabetes Care, Inc.2021-11-19
FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S050)Abbott Diabetes Care, Inc.2021-11-19
Guardian Connect System (P160007/S041)Medtronic Minimed2021-10-05
MiniMed 670G System (P160017/S094)Medtronic Minimed, Inc.2021-10-05
MiniMed 630G System with SmartGuard Technology (P150001/S092)Medtronic Minimed2021-10-05
FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S054)Abbott Diabetes Care, Inc.2021-09-30
FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S053)Abbott Diabetes Care, Inc.2021-09-01
FreeStyle Libre 14-Day Flash Glucose Monitoring System (P160030/S047)Abbott Diabetes Care, Inc.2021-09-01
13C-Spirulina Gastric Emptying Breath Test (GEBT) (P110015/S008)Advanced Breath Diagnostics2021-08-10
MiniMed 670G System, MiniMed 770G System (P160017/S092)Medtronic Minimed, Inc.2021-07-07
MiniMed 630G System (P150001/S091)Medtronic Minimed2021-07-07
MiniMed 670G System, MiniMed 770G System (P160017/S089)Medtronic Minimed, Inc.2021-04-19
13 C-Spirulina Gastric Emptying Breath Test (GEBT) (P110015/S007)Advanced Breath Diagnostics2021-03-16
iPro2 CGM System with Enlite Glucose Sensor (P150029/S036)Medtronic Minimed2021-02-25
Guardian Connect system (P160007/S040)Medtronic Minimed2021-02-25
MiniMed 630G System with SmartGuard (P150001/S090)Medtronic Minimed2021-02-25
Paradigm Real-Time Revel System (P150019/S063)Medtronic Minimed2021-02-25
MiniMed 530G System (P120010/S139)Medtronic, Inc.2021-02-25
MiniMed 670G System and MiniMed 770G System (P160017/S090)Medtronic Minimed, Inc.2021-02-25
Guardian Connect System (P160007/S035)Medtronic Minimed2021-01-14
MiniMed 630G System with Smart Guard (P150001/S084)Medtronic Minimed2021-01-14
miniMed 670G System (P160017/S083)Medtronic Minimed, Inc.2021-01-14
FreeStyle Libre 14-Day Flash Glucose Monitoring System (P160030/S046)Abbott Diabetes Care, Inc.2021-01-05
FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S052)Abbott Diabetes Care, Inc.2021-01-05
FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S051)Abbott Diabetes Care, Inc.2020-12-16
Freestyle Libre 14-Day Flash Glucose Monitoring System (P160030/S045)Abbott Diabetes Care, Inc.2020-12-16
Eversense Continuous Glucose Monitoring System (P160048/S017)Senseonics, Incorporated2020-12-11
Paradigm Real-Time REVEL System (P150019/S062)Medtronic Minimed2020-12-01
Guardian Connect system (P160007/S039)Medtronic Minimed2020-12-01
MiniMed 630G System (P150001/S089)Medtronic Minimed2020-12-01
MiniMed 530G System (P120010/S138)Medtronic, Inc.2020-12-01
iPro2 CGM System with Enlite Sensor (P150029/S035)Medtronic Minimed2020-12-01
MiniMed 670G System and MiniMed 770G System (P160017/S088)Medtronic Minimed, Inc.2020-12-01
MiniMed 630G System with SmartGuard (P150001/S088)Medtronic Minimed2020-10-09
MiniMed 670G System (P160017/S087)Medtronic Minimed, Inc.2020-10-09
G5 Mobile Continuous Glucose Monitoring System (P120005/S087)Dexcom, Inc.2020-09-03
MiniMed 630G System (P150001/S087)Medtronic Minimed2020-09-02
Guardian Connect System (P160007/S037)Medtronic Minimed2020-09-02
MiniMed 670G System (P160017/S086)Medtronic Minimed, Inc.2020-09-02
MiniMed 770G System (P160017/S076)Medtronic Minimed, Inc.2020-08-31
FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S049)Abbott Diabetes Care, Inc.2020-07-30
FreeStyle Libre 14-Day Flash Glucose Monitoring System (P160030/S043)Abbott Diabetes Care, Inc.2020-07-30
MiniMed 630G System with Smart Guard (P150001/S086)Medtronic Minimed2020-06-25
Guardian Connect System (P160007/S036)Medtronic Minimed2020-06-25
MiniMed 670G System (P160017/S085)Medtronic Minimed, Inc.2020-06-25
Freestyle Libre 14 day Flash Glucose Monitoring System (P160030/S042)Abbott Diabetes Care, Inc.2020-05-21
Guardian Connect System (P160007/S029)Medtronic Minimed2020-05-20
Freestyle Libre 14 day Flash Glucose Monitoring System (P160030/S039)Abbott Diabetes Care, Inc.2020-05-12
FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S046)Abbott Diabetes Care, Inc.2020-05-12
MiniMed 670G Insulin Pump (P160017/S082)Medtronic Minimed, Inc.2020-04-16
MiniMed 630G Insulin Pump (P150001/S083)Medtronic Minimed2020-04-16
FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S048)Abbott Diabetes Care, Inc.2020-04-13
FreeStyle Libre 14-day Flash Glucose Monitoring System (P160030/S041)Abbott Diabetes Care, Inc.2020-04-13
Guardian Connect System (P160007/S032)Medtronic Minimed2020-03-20
Medtronic MiniMed 630G System (P150001/S082)Medtronic Minimed2020-01-31
Guardian Connect System (P160007/S034)Medtronic Minimed2020-01-31
Medtronic MiniMed 670G System (P160017/S081)Medtronic Minimed, Inc.2020-01-31
MiniMed 630G Insulin Pump (P150001/S081)Medtronic Minimed2020-01-22
MiniMed 670G Insulin Pump (P160017/S080)Medtronic Minimed, Inc.2020-01-22
Dexcom G5 Mobile Continuous Glucose Monitoring System (P120005/S086)Dexcom, Inc.2020-01-08
MiniMed 530G System (P120010/S137)Medtronic, Inc.2019-12-19
MiniMed 630G System with SmartGuard (P150001/S078)Medtronic Minimed2019-12-19
iPro2 CGM System with Enlite Sensor (P150029/S034)Medtronic Minimed2019-12-19
MiniMed 630G System With SmartGuard (P150001/S079)Medtronic Minimed2019-12-19
Guardian Connect System (P160007/S033)Medtronic Minimed2019-12-19
Guardian Connect System (P160007/S031)Medtronic Minimed2019-12-19
MiniMed 670G System (P160017/S078)Medtronic Minimed, Inc.2019-12-19
MiniMed 670G System (P160017/S077)Medtronic Minimed, Inc.2019-12-19
Medtronic MiniMed 670G System (P160017/S079)Medtronic Minimed, Inc.2019-12-19
Paradigm Real-Time Revel System (P150019/S061)Medtronic Minimed2019-12-19
t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM System (P140015/S029)Tandem Diabetes Care, Inc.2019-12-19
t:slim X2 Insulin Pump with Basal-IQ Technology (P180008/S007)Tandem Diabetes Care, Inc.2019-12-19
MiniMed 630G System (P150001/S080)Medtronic Minimed2019-12-19
Guardian Connect system (P160007/S030)Medtronic Minimed2019-12-19
Freestyle Libre 14-day Flash Glucose Monitoring System (P160030/S040)Abbott Diabetes Care, Inc.2019-12-16
FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S047)Abbott Diabetes Care, Inc.2019-12-16
13C-Spirulina Gastric Emptying Breath Test (GEBT) (P110015/S006)Advanced Breath Diagnostics2019-11-25
EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM (P160048/S012)Senseonics, Incorporated2019-11-25
MiniMed 670G System (P150001/S074)Medtronic Minimed2019-11-22
MiniMed 670G System (P160017/S072)Medtronic Minimed, Inc.2019-11-22
Guardian Connect System (P160007/S026)Medtronic Minimed2019-11-22
Paradigm Real-Time Revel System (P150019/S059)Medtronic Minimed2019-11-22
MiniMed 530G System (P120010/S134)Medtronic, Inc.2019-11-22
iPro2 CGM System with Enlite Sensor (P150029/S032)Medtronic Minimed2019-11-22
MiniMed 670G System (P160017/S075)Medtronic Minimed, Inc.2019-11-15
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