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Clinical Chemistry

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

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RecordFirmDate
iPro2 CGM System (P150029/S033)Medtronic Minimed2019-11-15
MiniMed 530G System (P120010/S136)Medtronic, Inc.2019-11-15
Paradigm Real-Tme Revel System (P150019/S060)Medtronic Minimed2019-11-15
Guardian Connect System (P160007/S028)Medtronic Minimed2019-11-15
MiniMed 630G System (P150001/S077)Medtronic Minimed2019-11-15
Medtronic MiniMed 670G System (P160017/S074)Medtronic Minimed, Inc.2019-11-04
Guardian Connect System (P160007/S027)Medtronic Minimed2019-11-04
Medtronic MiniMed 630G System (P150001/S076)Medtronic Minimed2019-11-04
Medtronic MiniMed 530G System (P120010/S135)Medtronic, Inc.2019-11-04
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S083)Dexcom, Inc.2019-11-01
MiniMed 630G System with SmartGuard (P150001/S075)Medtronic Minimed2019-10-30
MiniMed 670G Insulin System (P160017/S073)Medtronic Minimed, Inc.2019-10-30
Eversense Continuous Glucose Monitoring System (P160048/S014)Senseonics, Incorporated2019-10-29
FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S039)Abbott Diabetes Care, Inc.2019-10-07
Freestyle Libre Flash Glucose Monitoring System (P160030/S030)Abbott Diabetes Care, Inc.2019-10-07
FreeStyle Libre 14 day Flash Glucose Monitoring System (P150021/S045)Abbott Diabetes Care, Inc.2019-09-12
Freestyle Libre Pro Flash Glucose Monitoring System (P160030/S038)Abbott Diabetes Care, Inc.2019-09-12
Eversense Continuous Glucose Monitoring System (P160048/S011)Senseonics, Incorporated2019-08-29
Eversense Continuous Glucose Monitoring System (P160048/S013)Senseonics, Incorporated2019-08-29
13C-Spirulina Gastric Emptying Breath Test (GEBT) (P110015/S005)Advanced Breath Diagnostics2019-08-29
Paradigm Real-Time Revel System (P150019/S058)Medtronic Minimed2019-08-26
MiniMed 530G System (P120010/S133)Medtronic, Inc.2019-08-26
Guardian Connect System (P160007/S025)Medtronic Minimed2019-08-26
iPro2 CGM System with Enlite Sensor (P150029/S031)Medtronic Minimed2019-08-26
MiniMed 630G System (P150001/S073)Medtronic Minimed2019-08-26
MiniMed 670G System (P160017/S070)Medtronic Minimed, Inc.2019-08-26
Dexcom G4 PLATINUM Continuous Glucose Monitoring System, Dexcom G5 Mobile Continuous Glucose Monitoring System (P120005/S082)Dexcom, Inc.2019-08-20
FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S044)Abbott Diabetes Care, Inc.2019-08-15
Freestyle Libre 14 day Flash Glucose Monitoring System (P160030/S037)Abbott Diabetes Care, Inc.2019-08-15
iPro2 System (P150029/S030)Medtronic Minimed2019-08-14
Medtronic Minimed 630G Insulin Pump (P150001/S072)Medtronic Minimed2019-08-14
Paradigm Real-Time Revel System (P150019/S057)Medtronic Minimed2019-08-14
MiniMed 530G System (P120010/S132)Medtronic, Inc.2019-08-14
Paradigm Real-Time System and Paradigm Real-Time Revel System (P980022/S208)Medtronic Minimed2019-08-14
Guardian Connect System (P160007/S024)Medtronic Minimed2019-08-14
MiniMed 670G System (P160017/S069)Medtronic Minimed, Inc.2019-08-14
FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S043)Abbott Diabetes Care, Inc.2019-08-13
FreeStyle Libre 14 day Flash Glucose Monitoring System (P160030/S036)Abbott Diabetes Care, Inc.2019-08-13
Guardian Connect System (P160007/S020)Medtronic Minimed2019-07-29
Eversense Continuous Glucose Monitoring System (P160048/S010)Senseonics, Incorporated2019-07-24
Guardian Connect system (P160007/S023)Medtronic Minimed2019-07-18
MiniMed 670G System (P160017/S067)Medtronic Minimed, Inc.2019-07-18
MINIMED 630G SYSTEM WITH SMARTGUARD(TM) (P150001/S071)Medtronic Minimed2019-07-18
IPRO2 CGM SYSTEM WITH ENLITE SENSOR (P150029/S029)Medtronic Minimed2019-07-18
MINIMED 530G SYSTEM (P120010/S131)Medtronic, Inc.2019-07-18
MiniMed 670G System (P160017/S062)Medtronic Minimed, Inc.2019-07-18
MiniMed 630G System with SmartGuard (P150001/S066)Medtronic Minimed2019-07-18
PARADIGM REAL-TIME REVEL SYSTEM (P150019/S056)Medtronic Minimed2019-07-18
MiniMed 630G System (P150001/S070)Medtronic Minimed2019-07-12
MiniMed 670G System (P160017/S066)Medtronic Minimed, Inc.2019-07-12
MiniMed 670G (MMT-1780) System (P160017/S061)Medtronic Minimed, Inc.2019-07-09
MiniMed 630G System with SmartGuard (P150001/S065)Medtronic Minimed2019-07-09
Eversense Continuous Glucose Monitoring System (P160048/S009)Senseonics, Incorporated2019-06-26
Freestyle Libre Pro Flash Glucose Monitoring System (P150021/S042)Abbott Diabetes Care, Inc.2019-06-20
Guardian Connect System (P160007/S022)Medtronic Minimed2019-06-20
MiniMed 670G System (P160017/S065)Medtronic Minimed, Inc.2019-06-20
Freestyle Libre 14 day Flash Glucose Monitoring System (P160030/S035)Abbott Diabetes Care, Inc.2019-06-20
MiniMed 630G System (P150001/S069)Medtronic Minimed2019-06-20
Minimed 630G System with SmartGuard (P150001/S068)Medtronic Minimed2019-06-14
MiniMed 670G System (P160017/S064)Medtronic Minimed, Inc.2019-06-14
Guardian Connect System (P160007/S021)Medtronic Minimed2019-06-14
Eversense Continuous Glucose Monitoring System (P160048/S006)Senseonics, Incorporated2019-06-06
Freestyle Libre Flash Glucose Monitoring System; Freestyle Libre 14 day Flash Glucose Monitoring System (P160030/S033)Abbott Diabetes Care, Inc.2019-05-10
FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S041)Abbott Diabetes Care, Inc.2019-05-10
Freestyle Libre Flash Glucose Monitoring System (P160030/S031)Abbott Diabetes Care, Inc.2019-05-06
MiniMed 670G System (P160017/S060)Medtronic Minimed, Inc.2019-05-01
Guardian Connect system (P160007/S017)Medtronic Minimed2019-05-01
MiniMed 630G System (P150001/S063)Medtronic Minimed2019-05-01
Minimed 630G System with SmartGuard (P150001/S064)Medtronic Minimed2019-05-01
MiniMed 670G System (P160017/S059)Medtronic Minimed, Inc.2019-05-01
Dexcom G5 Mobile Continuous Glucose Monitoring System (P120005/S081)Dexcom, Inc.2019-04-24
Flash Glucose Monitoring System (P150021/S036)Abbott Diabetes Care, Inc.2019-04-05
Freestyle Libre Pro (P160030/S028)Abbott Diabetes Care, Inc.2019-04-05
Guardian Link (3) Transmitter (MiniMed 630G System with SmartGuard) (P150001/S062)Medtronic Minimed2019-03-21
Guardian Connect Transmitter (P160007/S016)Medtronic Minimed2019-03-21
Guardian Link (3) Transmitter (MiniMed 670G System) (P160017/S058)Medtronic Minimed, Inc.2019-03-21
Freestyle Libre Pro Flash Glucose Monitoring System (P150021/S038)Abbott Diabetes Care, Inc.2019-03-19
Dexcom G5 Mobile Continuous Glucose Monitoring System (P120005/S080)Dexcom, Inc.2019-03-15
Real-Time REVEL System (P150019/S053)Medtronic Minimed2019-03-13
MiniMed 670G System (P160017/S055)Medtronic Minimed, Inc.2019-03-13
MiniMed 530G System (P120010/S128)Medtronic, Inc.2019-03-13
MiniMed 630G System (P150001/S059)Medtronic Minimed2019-03-13
iPro2 System (P150029/S026)Medtronic Minimed2019-03-13
Guardian Connect System (P160007/S013)Medtronic Minimed2019-03-13
MiniMed 630G System (P150001/S061)Medtronic Minimed2019-03-11
Paradigm real-Time Rvel System (P150019/S054)Medtronic Minimed2019-03-11
Guardian Connect System (P160007/S015)Medtronic Minimed2019-03-11
MiniMed 670G System (P160017/S057)Medtronic Minimed, Inc.2019-03-11
MiniMed 530G System (P120010/S129)Medtronic, Inc.2019-03-11
iPro2 CGM System with Enlite Sensor (P150029/S027)Medtronic Minimed2019-03-11
FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S040)Abbott Diabetes Care, Inc.2019-03-04
FreeStyle Libre 14day Flash Glucose Monitoring System (P160030/S032)Abbott Diabetes Care, Inc.2019-03-04
t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM System (P140015/S028)Tandem Diabetes Care, Inc.2019-03-01
FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S037)Abbott Diabetes Care, Inc.2019-02-26
Freestyle Libre Flash Glucose Monitoring System (P160030/S029)Abbott Diabetes Care, Inc.2019-02-26
MiniMed 670G System (P160017/S054)Medtronic Minimed, Inc.2019-02-21
MiniMed 630G System (P150001/S058)Medtronic Minimed2019-02-21
Eversense Continuous Glucose Monitoring System (CGMS-Entire System), Eversense Sensor , Eversense Insertion Tools, Evers (P160048/S003)Senseonics, Incorporated2019-02-01
Eversense Continuous Glucose Monitoring System (P160048/S008)Senseonics, Incorporated2019-01-28
Eversense Continuous Glucose Monitoring System (P160048/S007)Senseonics, Incorporated2019-01-15
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Every clearance here is in the API, with alerts when new ones post.