ClearanceBrief
Product code OZO ยท Class 3

Automated Insulin Dosing , Threshold Suspend

0510(k)s in 12 months (0 all time)
2recalls in 12 months (11 all time)
0recalls that name a 510(k)
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Top companies in OZO

Company510(k)sRecalls
Medtronic Inc.06
Medtronic MiniMed05
DateFirm and productCodeLinked 510(k)
Apr 2, 2026Medtronic MiniMed, Inc.
MiniMed 530G Insulin Pump (MMT-551, MMT-751)
Open, Classified
OZONone listed
Apr 2, 2026Medtronic MiniMed, Inc.
MiniMed 630G Insulin Pump (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
Open, Classified
OZONone listed
Mar 3, 2025Medtronic MiniMed, Inc.
MiniMed insulin pump, REF: 630G (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
Open, Classified
OZONone listed
Oct 3, 2024Medtronic MiniMed, Inc.
MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1755; MiniMed 700G Insulin Pump, REF: MMT-1800, MMT-1801, MMT-1805, MMT-1850, MMT-1851
Open, Classified
OZONone listed
May 23, 2022Medtronic MiniMed
MiniMed 630G Insulin Pump (U.S. and Canada Version)
Open, Classified
OZONone listed
Apr 30, 2020Medtronic Inc.
MiniMed 630G with SmartGuard, insulin pump, Ref/Model # MMT-1754K, MMT-1714K, MMT-1755K - Product Usage: intended for continuous delivery of basal insulin (at user selectable rates) and administratio
Open, Classified
OZONone listed
Feb 7, 2020Medtronic Inc.
Medtronic MiniMed 630G System with SmartGuard, Ref/Model # MMT-1515, MMT-1715, MMT-1714, MMT-1754, and MMT-1755 *US and Canada Version Only
Open, Classified
OZONone listed
Oct 3, 2018Medtronic Inc.
Medtronic MiniMed 630G 6025805-003_C, Rx Only Medtronic MiniMed 670G 6025805-005_B, Rx Only Medtronic MiniMed 640G (International)
Open, Classified
OZONone listed
Oct 10, 2017Medtronic Inc.
Medtronic CareLink iPro Therapy Management Software, MMT-7340 The CareLink iPro Therapy Management Software (model, MMT-7340) is intended to be used by a healthcare professional (HCP) with the iPro2
Terminated
OZONone listed
May 8, 2017Medtronic Inc.
MiniMed 630G Insulin Infusion Pump, Catalog No. MMT-1715, MMT-1755.
Terminated
OZONone listed
May 8, 2017Medtronic Inc.
MiniMed 620G Insulin Infusion Pump, Catalog No. MMT-1510, MMT-1710, MMT-1550, MMT-1750.
Terminated
OZONone listed

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