Pump, Infusion, Insulin
FDA product code LZG · 80 cleared devices
Class 2
General Hospital
- Regulation
- 21 CFR 880.5725
- Review panel
- CH
- Implant
- No
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1989-06-21 – 2026-09-02
LZG
2026-09-02
LZG
2026-04-08
Pivot Insulin Delivery System
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LZG
2024-09-04
Modular Medical MODD1 Insulin Delivery System
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LZG
2024-07-02
Extended Reservoir; MiniMed Reservoir
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LZG
2023-04-24
Omnipod GO Insulin Delivery Device
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LZG
2022-04-06
Extended Reservoir
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LZG
2021-08-13
Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System
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LZG
2019-10-21
Omnipod Insulin Management System, Omnipod DASH Insulin Management System
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LZG
2019-01-08
Omnipod Insulin Management System, Omnipod DASH Insulin Management System
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LZG
2018-06-01
Omnipod DASH Insulin Management System
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LZG
2017-04-18
OmniPod Insulin Management System
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LZG
2016-10-25
t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater
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LZG
2016-07-25
t:slim Insulin Delivery System
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LZG
2016-07-13
t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater
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LZG
2016-04-27
OmniPod Insulin Management System
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LZG
2013-08-29
OMNIPOD INSULIN MANAGEMENT SYSTEM
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LZG
2013-01-03
PEARL DIABETES MANAGEMENT SYSTEM
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LZG
2012-12-07
OMNIPOD INSULIN MANAGMENT SYSTEM
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LZG
2012-07-17
ACCU-CHECK COMBO SYSTEM
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LZG
2012-03-29
MEDTRONIC MINIMED PARADIGM INSULIN PUMPS
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LZG
2011-12-15
FREESTYLE GLUCOSE METER INCORPORATED INTO THE OMNIPOD INSULIN MANAGEMENT SYSTEMS
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LZG
2011-11-09
T:SLIM (TM) INSULIN DELIVERY SYSTEM
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LZG
2011-05-10
PEARL DIABETES MANAGEMENT SYSTEM
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LZG
2011-02-23
V-GO INSULIN DELIVERY SYSTEM
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LZG
2010-12-01
V-GO DISPOSABLE INSULIN DELIVERY DEVICE, MODEL# V-GO 20, V-GO 30, V-GO40
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LZG
2010-01-25
SOLO MICROPUMP INSULIN DELIVERY SYSTEM
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LZG
2009-07-23
SOLO INSULIN PATCH PUMP
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LZG
2009-02-20
FREESTYLE AVIATOR INSULIN DELIVERY AND BLOOD GLUCOSE MONITORING SYSTEM
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LZG
2008-12-17
SYMPHONY METER REMOTE
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LZG
2008-10-28
MODIFICATION TO:ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE
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LZG
2008-06-24
SYMPHONY GLUCOSE MANAGEMENT SYSTEM
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LZG
2008-06-06
NILIMEDIX ADI
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LZG
2008-04-25
PARADIGM INSULIN INFUSION PUMP, MODELS MMT-512, MMT-712, MMT-515 AND MMT-715
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LZG
2008-01-11
AVIATOR INSULIN PUMP
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LZG
2007-12-14
AMIGO INSULIN PUMP
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LZG
2007-03-30
EZMANAGER MAX DIABETES MANAGEMENT SOFTWARE
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LZG
2007-02-02
DANA DIABECARE IIS
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LZG
2006-11-01
DELTEC COZMO INSULIN INFUSION PUMP WITH COZMONITOR BLOOD GLUCOSE METER, MODELS 21-1815, 21-1816, 21-1817
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LZG
2006-06-15
ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MODEL 04625137001; ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWA
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LZG
2006-01-31
MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712E
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LZG
2005-12-23
INSULIN PUMP
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LZG
2005-09-13
ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE
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LZG
2005-08-16
BIOVALVE INSULIN DELIVERY SYSTEMS (BIDS)
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LZG
2005-05-09
AMIGO INSULIN PUMP
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LZG
2005-03-18
ACCU-CHEK SPIRIT
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LZG
2005-01-03
IXL-II DIABETES MANAGEMENT SYSTEM
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LZG
2004-12-10
ANIMAS MODEL IR1250 INSULIN INFUSION PUMP
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LZG
2004-12-01
MODIFICATION TO D-TRONPLUS
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LZG
2004-07-19
MEDTRONIC MINIMED PARADIGM MODEL 511 INSULIN PUMP
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LZG
2004-07-19
MODIFICATION TO MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP
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LZG
2004-05-27
SMITHS MEDICAL INSULIN INFUSION PUMP WITH COZMONITOR GLUCOSE METER
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LZG
2004-05-21
MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODELS MMT-515 AND MMT-715
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LZG
2003-12-19
IXL DIABETES MANAGEMENT SYSTEM
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LZG
2003-11-18
PARADIGMPAL, MODEL MMT-7330
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LZG
2003-10-23
DIABETES DATA MANAGEMENT SYSTEM (DDMS), MODEL 7333
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LZG
2003-10-16
MODEL IR 1200 INSULIN PUMP
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LZG
2003-06-17
MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP AND THE BD PARADIGM LINK GLUCOSE METER
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LZG
2003-06-05
EZMANAGER PLUS
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LZG
2002-10-29
DISETRONIC H-TRONPLUS INSULIN INFUSION PUMP
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LZG
2002-09-11
MODIFICATION TO DISETRONIC D-TRONPLUS INSULIN INFUSION PUMP
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LZG
2002-08-13
DELTEC INSULIN INFUSION PUMP AND ACCESSORIES
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LZG
2002-08-02
DANA DIABECARE II INSULIN PUMP & SUPERLINE-EASYRELEASE, SOFT-RELEASE-ST, & SOFT-RELEASE-R INFUSION SETS
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LZG
2002-08-02
DISETRONIC D-TRON INSULIN INFUSION PUMP
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LZG
2002-06-24
GLUCOPRO EVO INFUSION PUMP
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LZG
2002-05-29
MODEL R1000 IR INSULIN PUMP, EZLINK SOFTWARE, SERMON SOFTWARE, R1000 IR DOWNLOAD CRADLE, AND SERIAL INTERFACE ADAPTOR DO
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LZG
2001-12-12
MICROJET QUARK, MODEL U100 OR U40
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LZG
2000-08-14
DANA DIABECARE
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LZG
2000-02-10
R1000 SERIES INSULIN PUMP
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LZG
1999-12-30
DISETRONIC D-TRON INSULIN INFUSION PUMP
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LZG
1999-11-15
MINIMED COM-STATION, HARDWARE-7301; SOFTWARE-7311
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LZG
1999-06-15
DAHEDI INSULIN INFUSION PUMP
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LZG
1999-06-08
MINIMED 508 INSULIN PUMP
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LZG
1997-09-15
DISETRONIC H-TRON PLUS V 100 INSULIN INFUSION PUMP
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LZG
1997-08-15
MINIMED INFUSION PUMP, MODEL 507C
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LZG
1997-04-08
MINIMED INSULIN PUMP, MODEL 505
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LZG
1996-04-30
MINIMED INFUSION PUMP, MODEL MMT-507
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LZG
1991-04-12
H-TRON V 100 INSULIN INFUSION PUMP
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LZG
1990-07-02
MINIMED(R) MODEL 506 EXTERNAL INSULIN PUMP
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LZG
1990-02-23
MODIFIED BETATRON IV INSULIN INFUSION SYSTEM
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LZG
1989-06-21
PHARMA-PLAST INSULIN INFUSION SET
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