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Clinical Chemistry

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

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RecordFirmDate
IPRO2 CGM SYSTEM WITH ENLITE SENSOR (P150029/S005)Medtronic Minimed2017-01-11
MINIMED 630G SYSTEM WITH SMARTGUARD (P150001/S007)Medtronic Minimed2017-01-11
MINIMED 630G pump (P150001/S003)Medtronic Minimed2017-01-06
13C-SPIRULINA GEBT/13C-SPIRULINA GASTRIC EMPTYING BREATH TEST (GEBT) (P110015/S002)Advanced Breath Diagnostics2017-01-06
MINIMED 530G SYSTEM (P120010/S099)Medtronic, Inc.2016-12-27
IPRO2 CGM SYSTEM WITH ENLITE SENSOR (P150029/S004)Medtronic Minimed2016-12-27
MiniMed 670G System (P160017/S006)Medtronic Minimed, Inc.2016-12-27
MINIMED 630G SYSTEM WITH SMARTGUARD (P150001/S006)Medtronic Minimed2016-12-27
PARADIGM REAL-TIME REVEL SYSTEM (P150019/S026)Medtronic Minimed2016-12-27
MiniMed 670G System (P160017/S004)Medtronic Minimed, Inc.2016-12-22
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S041)Dexcom, Inc.2016-12-20
GUARDIAN LINK TRANSMITTER (P160017/S007)Medtronic Minimed, Inc.2016-12-19
GURADIAN LINK TRANSMITTER (P150001/S005)Medtronic Minimed2016-12-19
MINILINK REAL TIME TRANSMITTER (P150019/S025)Medtronic Minimed2016-12-19
MINILINK REAL TIME TRANSMITTER (P980022/S197)Medtronic Minimed2016-12-19
IPRO2 RECORDER (P150029/S003)Medtronic Minimed2016-12-19
MINIMED 530G SYSTEM (P120010/S098)Medtronic, Inc.2016-12-19
OneTouch Vibe™ Plus System (P130007/S016)Animas Corp.2016-12-16
DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM (P120005/S055)Dexcom, Inc.2016-12-09
Artificial Pancreas Device System, Threshold Suspend (P120010/S091)Medtronic, Inc.2016-12-08
Sensor-Enabled Pump System-Continuous Glucose Monitoring System (P150019/S016)Medtronic Minimed2016-12-08
MINIMED 630G SYSTEM WITH SMARTGUARD (P150001/S004)Medtronic Minimed2016-12-02
IPRO2 CGM SYSTEM WITH ENLITE SENSOR (P150029/S002)Medtronic Minimed2016-12-02
MINIMED 530G SYSTEM (P120010/S097)Medtronic, Inc.2016-12-02
PARADIGM REAL-TIME REVEL SYSTEM (P150019/S023)Medtronic Minimed2016-12-02
MiniMed 670G System (P160017/S005)Medtronic Minimed, Inc.2016-12-02
DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM (P120005/S056)Dexcom, Inc.2016-11-16
MiniMed 670G System (P160017/S001)Medtronic Minimed, Inc.2016-11-15
MiniMed 670G Insulin Pump (P160017/S002)Medtronic Minimed, Inc.2016-11-10
Enlite Sensor (P150001/S002)Medtronic Minimed2016-11-08
ANIMAS VIBE SYSTEM (P130007/S019)Animas Corp.2016-11-05
ANIMAS VIBE SYSTEM (P130007/S022)Animas Corp.2016-11-05
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S053)Dexcom, Inc.2016-10-26
MINIMED 530G INSULIN PUMP (P120010/S095)Medtronic, Inc.2016-10-19
Paradigm REAL-Time Revel Insulin Pump (P980022/S195)Medtronic Minimed2016-10-19
Paradigm REAL-Time Insulin Pump (P150019/S020)Medtronic Minimed2016-10-19
Paradigm REAL-Time Revel Insulin Pump with Enlite Sensor System (P150019/S022)Medtronic Minimed2016-10-13
T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM SYSTEM (P140015/S011)Tandem Diabetes Care, Inc.2016-10-04
T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM (P140015/S012)Tandem Diabetes Care, Inc.2016-10-04
MiniMed 630G Pump (P150001/S001)Medtronic Minimed2016-09-30
MiniMed 670G System (P160017)Medtronic Minimed, Inc.2016-09-28
FREESTYLE LIBRE PRO FLASH GLUCOSE MONITORING SYSTEM (P150021)Abbott Diabetes Care, Inc.2016-09-23
T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM (P140015/S015)Tandem Diabetes Care, Inc.2016-09-23
DEXCOM G5 MOBILE CONTIUOUS GLUCOSE MONITORING SYSTEM (P120005/S049)Dexcom, Inc.2016-09-16
ANIMAS VIBE SYSTEM (P130007/S020)Animas Corp.2016-09-15
T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM (P140015/S014)Tandem Diabetes Care, Inc.2016-09-08
T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM (P140015/S013)Tandem Diabetes Care, Inc.2016-09-01
MiniMed 530G Insulin Pump (P120010/S093)Medtronic, Inc.2016-08-25
PARADIGM REAL-TIME REVEL INSULIN SYSTEM (P150019/S018)Medtronic Minimed2016-08-25
Paradigm Real-Time Revel Insulin Pump & Paradigm Real-Time Insulin Pump. (P980022/S193)Medtronic Minimed2016-08-25
G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM (P120005/S052)Dexcom, Inc.2016-08-25
ANIMAS VIBE SYSTEM (P130007/S018)Animas Corp.2016-08-24
IPRO2 CGM SYSTEM WITH ENLITE SENSOR (P150029/S001)Medtronic Minimed2016-08-15
PARADIGM REAL-TIME REVEL SYSTEM (P150019/S017)Medtronic Minimed2016-08-15
MINIMED 530G SYSTEM (P120010/S092)Medtronic, Inc.2016-08-15
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM/DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S051)Dexcom, Inc.2016-08-12
MINIMED 630G SYSTEM WITH SMARTGUARD(TM) (P150001)Medtronic Minimed2016-08-10
DEXCOM G5 Mobile Continuous Glucose Monitoring System (P120005/S048)Dexcom, Inc.2016-08-02
PARADIGM REAL-TIME REVEL SYSTEM (P150019/S007)Medtronic Minimed2016-07-27
T:SLIM G4TM INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM (P140015/S010)Tandem Diabetes Care, Inc.2016-07-20
T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM (P140015/S009)Tandem Diabetes Care, Inc.2016-07-08
DEXCOM G4 PLATINUM RECEIVER, G4 PLATINUM PEDIATRIC RECEIVER, DEXCOM G5 MOBILE RECEIVER, DEXCOM G4 PLATINUM RECEIVER WIT (P120005/S047)Dexcom, Inc.2016-07-08
ANIMAS VIBE SYSTEM (P130007/S014)Animas Corp.2016-07-06
ANIMAS VIBE SYSTEM (P130007/S012)Animas Corp.2016-06-30
IPRO2 CGM SYSTEM WITH ENLITE SENSOR (P150029)Medtronic Minimed2016-06-17
ANIMAS VIBE SYSTEM (P130007/S011)Animas Corp.2016-06-16
MINIMED 530G INSULIN PUMP (P120010/S076)Medtronic, Inc.2016-06-03
PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP (P980022/S183)Medtronic Minimed2016-06-03
ANIMAS VIBE SYSTEM (P130007/S015)Animas Corp.2016-06-01
ANIMAS VIBE SYSTEM (P130007/S013)Animas Corp.2016-05-12
MINIMED 530G SYSTEM (P120010/S088)Medtronic, Inc.2016-04-27
PARADIGM REAL-TIME REVEL SYSTEM (P150019/S013)Medtronic Minimed2016-04-27
MINIMED 530G SYSTEM (P120010/S087)Medtronic, Inc.2016-04-21
PARADIGM REAL-TIME REVEL SYSTEM (P150019/S011)Medtronic Minimed2016-04-21
PARADIGM REAL-TIME REVEL SYSTEM (P150019/S012)Medtronic Minimed2016-04-21
CONTINUOUS GLUCOSE MONITORING SYSTEM (P980022/S191)Medtronic Minimed2016-04-21
DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM (P120005/S046)Dexcom, Inc.2016-04-21
MINIMED 530G SYSTEM (P120010/S086)Medtronic, Inc.2016-04-21
PARADIGM REAL-TIME REVEL SYSTEM (P150019/S010)Medtronic Minimed2016-04-07
MINIMED 530G SYSTEM (P120010/S085)Medtronic, Inc.2016-04-07
PARADIGM REAL-TIME REVEL SYSTEM (P150019/S009)Medtronic Minimed2016-04-05
CONTINUOUS GLUCOSE MONITORING SYSTEM (P980022/S190)Medtronic Minimed2016-04-05
MINIMED 530G SYSTEM (P120010/S084)Medtronic, Inc.2016-04-05
T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM (P140015/S006)Tandem Diabetes Care, Inc.2016-03-24
MINIMED 530G SYSTEM (P120010/S083)Medtronic, Inc.2016-03-23
PARADIGM REAL-TIME REVEL SYSTEM (P150019/S008)Medtronic Minimed2016-03-23
PARADIGM REAL-TIME REVEL SYSTEM (P150019/S005)Medtronic Minimed2016-03-17
PARADIGM REAL-TIME REVEL SYSTEM (P150019/S006)Medtronic Minimed2016-03-17
PARADIGM REAL-TIME REVEL SYSTEM (P150019/S003)Medtronic Minimed2016-03-16
PARADIGM REAL-TIME REVEL SYSTEM (P150019/S004)Medtronic Minimed2016-03-16
PARADIGM REAL-TIME REVEL SYSTEM (P150019/S001)Medtronic Minimed2016-03-03
PARADIGM REAL-TIME REVEL SYSTEM (P150019/S002)Medtronic Minimed2016-03-03
ANIMAS VIBE SYSTEM (P130007/S010)Animas Corp.2016-03-02
MiniMed 530G System (P120010/S061)Medtronic, Inc.2016-02-22
MINIMED 530G SYSTEM (P120010/S070)Medtronic, Inc.2016-02-18
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM,DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S042)Dexcom, Inc.2016-02-05
RAPID FFN FOR THE TLIIQ SYSTEM (P920048/S011)Hologic, Inc.2016-02-05
MINIMED 530G INSULIN PUMP (P120010/S074)Medtronic, Inc.2016-02-01
PARADIGM REAL-TIME INSULIN PUMP. PARADIGM REAL-TIME REVEL INSULIN PUMP. (P980022/S181)Medtronic Minimed2016-02-01
T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM (P140015/S007)Tandem Diabetes Care, Inc.2016-01-28
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Every clearance here is in the API, with alerts when new ones post.