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Clinical Chemistry

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

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RecordFirmDate
MINIMED 530G INSULIN PUMPS (P120010/S043)Medtronic, Inc.2014-12-03
PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMPS (P980022/S170)Medtronic Minimed2014-12-03
SEN-SERTER (P980022/S171)Medtronic Minimed2014-12-03
PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP (P980022/S165)Medtronic Minimed2014-11-26
MYSENTRY SYSTEM ; MYSENTRY MONITOR (P980022/S169)Medtronic Minimed2014-11-26
MINIMED 530G INSULIN PUMP (P120010/S039)Medtronic, Inc.2014-11-26
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S029)Dexcom, Inc.2014-11-26
ANIMAS VIBE SYSTEM (P130007)Animas Corp.2014-11-25
SOF SENSOR (P980022/S162)Medtronic Minimed2014-11-21
ENLITE SENSOR (P120010/S038)Medtronic, Inc.2014-11-21
PARADIGM REAL-TIME INSULIN PUMP (P980022/S163)Medtronic Minimed2014-11-19
MINIMED 530G INSULIN PUMP (P120010/S037)Medtronic, Inc.2014-11-19
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITIORING SYSTEM (P120005/S018)Dexcom, Inc.2014-10-21
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S009)Dexcom, Inc.2014-10-17
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S026)Dexcom, Inc.2014-10-09
MINIMED 530G INSULIN PUMP (P120010/S033)Medtronic, Inc.2014-10-08
PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP (P980022/S160)Medtronic Minimed2014-10-08
MINILINK REAL-TIME TRANSMITTER, IPRO2 RECORDER (P980022/S156)Medtronic Minimed2014-10-02
ENLITE GLUCOSE SENSORS (P120010/S034)Medtronic, Inc.2014-10-02
MINILINK REAL-TIME TRANSMITTER (P120010/S023)Medtronic, Inc.2014-10-02
ENLITE GLUCOSE SENSORS (P120010/S035)Medtronic, Inc.2014-10-02
MINIMED 530G SYSTEM (P120010/S032)Medtronic, Inc.2014-09-29
MINILINK REAL-TIME SYSTEM,IPRO RECORDER CGMS SYSTEM,IPRO2 RECORDER CGM SYSTEM (P980022/S143)Medtronic Minimed2014-09-25
MINILINK REAL-TIME TRANSMITTER (P120010/S003)Medtronic, Inc.2014-09-25
ENLITE GLUCOSE SENSOR (P120010/S031)Medtronic, Inc.2014-08-28
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S027)Dexcom, Inc.2014-08-22
MINIMED 530G INSULIN PUMP (P120010/S005)Medtronic, Inc.2014-08-21
PARADIGM REAL-TIME INSULIN PUMP (P980022/S147)Medtronic Minimed2014-08-21
RAPID FFN CONTROL KIT (P920048/S008)Hologic, Inc.2014-07-24
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S025)Dexcom, Inc.2014-07-24
SOF SENSOR (P980022/S158)Medtronic Minimed2014-07-24
ENLITE GLUCOSE SENSOR (P120010/S027)Medtronic, Inc.2014-07-24
ENLITE SENSOR (P120010/S028)Medtronic, Inc.2014-07-22
MYSENTRY SYSTEM, MYSENTRY MONITOR, MYSENTRY OUTPOST (P980022/S157)Medtronic Minimed2014-07-18
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S024)Dexcom, Inc.2014-07-16
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S023)Dexcom, Inc.2014-07-14
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S019)Dexcom, Inc.2014-07-11
SOF GLUCOSE SENSOR, SOF GLUCOSE SENSOR (MMT-7002, MMT-7003) (P980022/S154)Medtronic Minimed2014-07-10
ENLITE GLUCOSE SENSOR, ENLITE GLUCOSE SENSOR (MMT-7008) (P120010/S021)Medtronic, Inc.2014-07-10
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S022)Dexcom, Inc.2014-07-10
ENLITE GLUCOSE SENSOR (P120010/S025)Medtronic, Inc.2014-07-02
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S021)Dexcom, Inc.2014-06-30
GLUCOSE SENSOR ENLITE (P120010/S019)Medtronic, Inc.2014-06-18
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S020)Dexcom, Inc.2014-06-18
MINIMED 530G INSULIN PUMP (P120010/S016)Medtronic, Inc.2014-06-03
DEXCOM G4 PLATINUM PROFESSIONAL CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S011)Dexcom, Inc.2014-06-03
PARADIGM REAL-TIME REVEL INSULIN PUMP (P980022/S153)Medtronic Minimed2014-05-29
PARADIGM REAL TIME INSULIN PUMPS, PARADIGM REAL TIME REVEL INSULINPUMPS, GUARDIAN REAL TIME MONITOR. (P980022/S155)Medtronic Minimed2014-05-14
ENLITE SENSOR (P120010/S022)Medtronic, Inc.2014-05-14
MINIMED 530G INSULIN PUMP (P120010/S020)Medtronic, Inc.2014-05-08
DEXCON G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S017)Dexcom, Inc.2014-05-02
ENLITE SENSOR (P120010/S017)Medtronic, Inc.2014-04-07
ENLITE SENSOR (P120010/S014)Medtronic, Inc.2014-04-03
ENLITE GLUCOSE SENSOR, ENLITE SERTER (P120010/S015)Medtronic, Inc.2014-03-31
ENLITE SENSOR (P120010/S013)Medtronic, Inc.2014-03-26
ENLITE SENSOR (P120010/S012)Medtronic, Inc.2014-03-21
ENLITE GLUCOSE SENSOR (P120010/S011)Medtronic, Inc.2014-03-20
MINIMED 530G INSULIN PUMP (P120010/S008)Medtronic, Inc.2014-03-13
PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP, (P980022/S150)Medtronic Minimed2014-03-13
MINIMED 530G INSULIN PUMPS; ENLITE SENSOR (P120010/S010)Medtronic, Inc.2014-03-06
DEXCOM SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEM (P050012/S052)Dexcom, Inc.2014-03-05
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S014)Dexcom, Inc.2014-03-05
PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP (P980022/S151)Medtronic Minimed2014-02-27
MINIMED 530G INSULIN PUMP (P120010/S009)Medtronic, Inc.2014-02-27
DEXCOM G4 PLATINUM CONTINOUS GLUCOSE MONITORING SYSTEM (P120005/S013)Dexcom, Inc.2014-02-26
DEXCOM G4® PLATINUM (PEDIATRIC) CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S002)Dexcom, Inc.2014-02-03
PARADIGM REAL-TIME INSULIN PUMPS;PARADIGM REAL-TIME REVEL INSULIN PUMPS (P980022/S133)Medtronic Minimed2014-01-15
MINILINK REAL-TIME SYSTEM (P980022/S119)Medtronic Minimed2013-12-26
PARADIGM REAL-TIME INSULIN PUMPS (P980022/S149)Medtronic Minimed2013-12-24
SOF-SENSOR (P980022/S142)Medtronic Minimed2013-12-06
SOF-SENSOR (P980022/S145)Medtronic Minimed2013-12-06
ENLITE SENSOR (P120010/S002)Medtronic, Inc.2013-12-06
PARADIGM REAL-TIME SYSTEM, PARADIGM REAL-TIME REVEL SYSTEM AND GUARDIAN REAL-TIME CGM SYSTEM (P980022/S148)Medtronic Minimed2013-12-05
MINIMED 530G INSULIN PUMP (P120010/S006)Medtronic, Inc.2013-12-05
PARADIGM REAL TIME PUMP & PARADIGM REAL TIME REVEL INSULIN PUMP (P980022/S138)Medtronic Minimed2013-10-31
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S012)Dexcom, Inc.2013-10-18
MINIMED 530G SYSTEM (P120010)Medtronic, Inc.2013-09-26
PARADIGM REAL TIME INSULIN PUMP, PARADIGN REAL TIME REVEL INSULIN PUMP (P980022/S137)Medtronic Minimed2013-09-24
PARADIGM REAL-TIME PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP (P980022/S136)Medtronic Minimed2013-09-13
PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP (P980022/S130)Medtronic Minimed2013-08-26
PARADIGUM REAL TIME PUMP; PARADIGUM REAL TIME REVEL INSULIN PUMP (P980022/S135)Medtronic Minimed2013-08-23
DEXCOM G4 PLATINUM CONTINOUS GLUCOSE MONITORING SYSTEM (P120005/S008)Dexcom, Inc.2013-08-21
DEXCOM SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEM (P050012/S051)Dexcom, Inc.2013-08-19
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S010)Dexcom, Inc.2013-08-19
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S005)Dexcom, Inc.2013-08-14
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S007)Dexcom, Inc.2013-08-09
PARADIGM REAL-TIME REVEL INSULIN PUMP (P980022/S134)Medtronic Minimed2013-07-08
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S006)Dexcom, Inc.2013-06-28
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S004)Dexcom, Inc.2013-04-11
DEXCOM G4 PLANTINUM CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S003)Dexcom, Inc.2013-03-26
IPRO2 RECORDER, IPRO2 PROFESSIONAL CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM (P980022/S131)Medtronic Minimed2013-03-22
SOF-SENSOR GLUCOSE SENSOR (P980022/S126)Medtronic Minimed2013-03-20
DEXCOM SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEM (P050012/S050)Dexcom, Inc.2013-03-11
PARADIGM REAL-TIME INSULIN PUMP (P980022/S132)Medtronic Minimed2013-03-01
IPRO2 CGM RECORDER (P980022/S127)Medtronic Minimed2013-02-20
MEDTRONIC MINIMED CONTINUOUS SUBCUTANEOUS GLUCOSE MONITORING SYSTEM (P980022/S128)Medtronic Minimed2013-02-11
PARADIGM REAL-TIME PUMP, PARADIGM REAL TIME REVEL INSULIN PUMP (P980022/S129)Medtronic Minimed2013-02-11
PARADIGM REAL-TIME PUMP, PARADIGM REAL-TIME REVEL UNSULIN PUMP (P980022/S125)Medtronic Minimed2013-01-29
DEXCOM G4 PLATINUM PROFESSIONAL CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S001)Dexcom, Inc.2013-01-04
DEXCOM SEVEN PLUS SYSTEM (P050012/S046)Dexcom, Inc.2012-12-14
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