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Clinical Chemistry

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

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RecordFirmDate
ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND (P120010/S082)Medtronic, Inc.2016-01-27
MINIMED 530G INSULIN PUMP (P120010/S054)Medtronic, Inc.2016-01-22
PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP (P980022/S177)Medtronic Minimed2016-01-22
T:SLIM G4 INSULIN PUMP WITH DEXCON G4 PLATINUM CGM (P140015/S008)Tandem Diabetes Care, Inc.2016-01-22
MINIMED 530G SYSTEM, MINILINK REAL-TIME SYSTEM (P120010/S064)Medtronic, Inc.2016-01-21
PARADIGM REAL-TIME SYSTEM, PARADIGM REAL-TIME REVEL SYSTEM, MINILINK REAL-TIME SYSTEM, GUARDIAN REAL TIME SYSTEM (P980022/S179)Medtronic Minimed2016-01-21
ENLITE GLUCOSE SENSORS (P120010/S072)Medtronic, Inc.2016-01-21
DEXCOM G4TM PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM, DEXCOM G5 MOBILE CONTINIOUS GLUCOSE MONITORING SYSTEM (P120005/S043)Dexcom, Inc.2016-01-14
ENLITE GLUCOSE SENSOR (P120010/S081)Medtronic, Inc.2016-01-14
DEXCOM G4 PLATINUM CONTINUOUS MONITORING SYSTEM, DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S044)Dexcom, Inc.2016-01-13
ANIMAS VIBE SYSTEM (P130007/S004)Animas Corp.2015-12-24
MINIMED 530G SYSTEM (P120010/S080)Medtronic, Inc.2015-12-23
PARADIGM REAL-TIME SYSTEM, PARADIGM REAL-TIME REVEL SYSTEM (P980022/S189)Medtronic Minimed2015-12-23
PARADIGM REAL-TIME SYSTEM,PARADIGM REAL-TIME REVEL SYSTEM (P980022/S186)Medtronic Minimed2015-12-09
PARADIGM REAL-TIME INSULIN PUMP & PARADIGM REAL-TIME REVEL INSULIN PUMP (P980022/S188)Medtronic Minimed2015-12-09
MINIMED 530G SYSTEM (P120010/S077)Medtronic, Inc.2015-12-09
MINIMED 530G (P120010/S079)Medtronic, Inc.2015-12-09
PARADIGM REAL-TIME INSULIN PUMP;PARADIGM REAL-TIME REVEL INSULIN PUMP (P980022/S187)Medtronic Minimed2015-12-08
MINIMED 530G INSULIN PUMP (P120010/S078)Medtronic, Inc.2015-12-08
PARADIGM REAL-TIME REVEL SYSTEM (P150019)Medtronic Minimed2015-12-07
PARADIGM REAL-TIME INSULIN PUMP; PARADIGM REAL-TIME REVEL INSULIN PUMP (P980022/S184)Medtronic Minimed2015-12-04
MINIMED 530G INSULIN PUMP (P120010/S075)Medtronic, Inc.2015-12-03
PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP (P980022/S182)Medtronic Minimed2015-12-03
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S040)Dexcom, Inc.2015-11-25
PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP (P980022/S146)Medtronic Minimed2015-11-23
MINIMED 530G INSULIN PUMP (P120010/S004)Medtronic, Inc.2015-11-23
ENLITE SENSOR (P120010/S073)Medtronic, Inc.2015-11-18
ENLITE SENSOR (P120010/S029)Medtronic, Inc.2015-11-12
SOF-SENSOR (P980022/S159)Medtronic Minimed2015-11-12
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S038)Dexcom, Inc.2015-11-06
ANIMAL VIBE SYSTEM (P130007/S008)Animas Corp.2015-11-03
ANIMAS VIBE SYSTEM (P130007/S003)Animas Corp.2015-10-30
DEXCOM G4TM PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM; DEXCON G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S039)Dexcom, Inc.2015-10-23
ANIMAS VIBE SYSTEM (P130007/S009)Animas Corp.2015-10-21
TSLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM SYSTEM (P140015/S005)Tandem Diabetes Care, Inc.2015-10-15
T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM (P140015/S001)Tandem Diabetes Care, Inc.2015-10-08
TSLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM SYSTEM. (P140015/S003)Tandem Diabetes Care, Inc.2015-10-08
T SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM SYSTEM (P140015/S002)Tandem Diabetes Care, Inc.2015-10-08
T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM SYSTEM (P140015/S004)Tandem Diabetes Care, Inc.2015-10-08
SOF SENSOR (P980022/S140)Medtronic Minimed2015-10-02
ENLITE SENSOR (P120010/S001)Medtronic, Inc.2015-10-02
MINIMED 530G INSULIN PUMP (P120010/S046)Medtronic, Inc.2015-10-02
ANIMAS VIBE SYSTEM (P130007/S005)Animas Corp.2015-09-24
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S037)Dexcom, Inc.2015-09-23
MINIMED 530G SYSTEM (P120010/S071)Medtronic, Inc.2015-09-18
T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM (P140015)Tandem Diabetes Care, Inc.2015-09-08
MINIMED 530G INSULIN PUMP (P120010/S052)Medtronic, Inc.2015-08-25
PARADIGM REAL-TIME INSULIN PUMP; PARADIGM REAL-TIME REVEL INSULIN PUMP (P980022/S176)Medtronic Minimed2015-08-25
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S033)Dexcom, Inc.2015-08-19
ANIMAS VIBE SYSTEM (P130007/S007)Animas Corp.2015-08-18
ANIMAS VIBE SYSTEM (P130007/S006)Animas Corp.2015-08-10
ENLITE SENSOR (P120010/S067)Medtronic, Inc.2015-07-29
ENLITE GLUCOSE SENSORS (P120010/S068)Medtronic, Inc.2015-07-22
DEXCOM G4TM PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S036)Dexcom, Inc.2015-07-02
RAPID FFN FOR THE TLIIQ SYSTEM (P920048/S009)Hologic, Inc.2015-06-24
ENLITE SENSOR (P120010/S069)Medtronic, Inc.2015-06-24
ANIMAS VIBE SYSTEM (P130007/S002)Animas Corp.2015-06-22
ENLITE GLUCOSE SENSOR (P120010/S058)Medtronic, Inc.2015-06-09
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S035)Dexcom, Inc.2015-06-03
DEXCOM G4 PLATINUM (PEDIATRIC) CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S031)Dexcom, Inc.2015-05-22
MINIMED 530G SYSTEM (P120010/S062)Medtronic, Inc.2015-05-19
CONTINUOUS GLUCOSE MONITORING SYSTEM (P980022/S178)Medtronic Minimed2015-05-19
ENLITE SENSOR (P120010/S066)Medtronic, Inc.2015-05-15
SOF-SENSOR (P980022/S166)Medtronic Minimed2015-05-13
ENLITE SENSOR (P120010/S040)Medtronic, Inc.2015-05-13
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S034)Dexcom, Inc.2015-04-16
PARADIGM REAL-TIME INSULIN PUMPS, PARADIGM REAL-TIME REVEL INSULIN PUMPS (P980022/S180)Medtronic Minimed2015-04-16
MINIMED 530G INSULIN PUMPS (P120010/S065)Medtronic, Inc.2015-04-16
ANIMAS VIBE SYSTEM (P130007/S001)Animas Corp.2015-04-14
GASTRIC EMPTYING BREATH TEST (GEBT) (P110015)Advanced Breath Diagnostics2015-04-06
ENLITE SENSOR (P120010/S063)Medtronic, Inc.2015-03-23
MINIMED 530G SYSTEM (P120010/S056)Medtronic, Inc.2015-03-20
ENLITE SENSOR (P120010/S057)Medtronic, Inc.2015-02-27
MINIMED 530G INSULIN PUMP (P120010/S059)Medtronic, Inc.2015-02-25
ENLITE GLUCOSE SENSORS (P120010/S060)Medtronic, Inc.2015-02-25
ENLITE GLUCOSE SENSOR (P120010/S024)Medtronic, Inc.2015-02-19
PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP (P980022/S161)Medtronic Minimed2015-02-13
MINIMED 530G INSULIN PUMP (P120010/S036)Medtronic, Inc.2015-02-13
MINILINK TRANSMITTER, WATERTIGHT TESTER, MINILINK KIT WITH ENLITE SERTER AND MINILINK REPLACEMENT KIT (P120010/S026)Medtronic, Inc.2015-02-04
ENLITE SENSOR (P120010/S030)Medtronic, Inc.2015-02-04
ENLITE GLUCOSE SENSOR. (P120010/S055)Medtronic, Inc.2015-01-30
ENLITE SENSOR (P120010/S042)Medtronic, Inc.2015-01-29
ENLITE GLUCOSE SENSORS (P120010/S053)Medtronic, Inc.2015-01-29
SOF-SENSOR (P980022/S167)Medtronic Minimed2015-01-29
GUARDIAN REAL TIME MONITOR (P980022/S168)Medtronic Minimed2015-01-28
ENLITE GLUCOSE SENSORS (P120010/S041)Medtronic, Inc.2015-01-28
DEXCOM G4 PLATINUM CONTINUOUS MONITORING SYSTEM, DEXCOM SHARE SYSTEM (P120005/S028)Dexcom, Inc.2015-01-23
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S032)Dexcom, Inc.2015-01-22
MINI-MED 530G INSULIN PUMP (P120010/S051)Medtronic, Inc.2015-01-14
PARADIGM REAL-TIME INSULIN PUMP; PARADIGM REAL-TIME REVEL INSLIN PUMP (P980022/S175)Medtronic Minimed2015-01-14
ENLITE GLUCOSE SENSORS (P120010/S050)Medtronic, Inc.2015-01-07
PARADIGM REAL-TIME SYSTEM, PARADIGM REAL-TIME REVEL SYSTEM, MINILINK REAL-TIME SYSTEM AND GUARDIAN REAL-TIME SYSTEM (P980022/S174)Medtronic Minimed2015-01-02
MINIMED 530G SYSTEM AND MINILINK REAL-TIME SYSTEM (P120010/S049)Medtronic, Inc.2015-01-02
ENLITE GLUCOSE SENSORS (P120010/S048)Medtronic, Inc.2014-12-31
MINIMED 530G SYSTEM (P120010/S047)Medtronic, Inc.2014-12-19
PARADIGM REAL-TIME INSULIN PUMP AND PARADIGM REAL TIME REVEL INSULIN PUMP (P980022/S173)Medtronic Minimed2014-12-19
DEXCOM G4TM PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S030)Dexcom, Inc.2014-12-12
PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP, GUARDIAN REAL-TIME MONITOR (P980022/S172)Medtronic Minimed2014-12-05
ARTIFICIAL PANCREAS DEVICE SYSTEM (P120010/S045)Medtronic, Inc.2014-12-04
MINILINK REAL-TIME TRASMITTER, IPRO2 DIGITAL RECORDER (P980022/S164)Medtronic Minimed2014-12-04
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