ClearanceBrief
Product code MDS ยท Class 3

Sensor, Glucose, Invasive

0510(k)s in 12 months (0 all time)
0recalls in 12 months (57 all time)
1recalls that name a 510(k)
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Top companies in MDS

DateFirm and productCodeLinked 510(k)
Oct 2, 2025Medtronic MiniMed, Inc.
Medtronic, Simplera Sensor, REF: MMT-5100JD1
Open, Classified
MDSNone listed
Jan 1, 2023Medtronic MiniMed
Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system
Open, Classified
MDSNone listed
Feb 26, 2021Medtronic Inc.
Medtronic, REF: MMT-7008D, Enlite Glucose Sensor for the following packaging: ENLITE AUS 1 PRESS 1PK; GTIN: 00763000252045 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose
Open, Classified
MDSNone listed
Feb 26, 2021Medtronic Inc.
Medtronic, REF: MMT-7008C, Enlite Glucose Sensor for the following packaging: ENLITE AUS 1 PRESS 5PK/ GTIN: 20763000252032 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose
Open, Classified
MDSNone listed
Feb 26, 2021Medtronic Inc.
Medtronic REF: MMT-7020D5 Guardian Sensor (3) for the following packaging: GS3 1PK 1L AUS/ GTIN 00763000252069 GS3 1PK 1L AUS/ GTIN 00763000414375 Product Usage: intended for use with Medtronic Dia
Open, Classified
MDSNone listed
Feb 26, 2021Medtronic Inc.
Medtronic REF: MMT-7020D4 Guardian Sensor (3) for the following packaging: GS3 1PK 2L CANADA/ GTIN: 00763000179595 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensin
Open, Classified
MDSNone listed
Feb 26, 2021Medtronic Inc.
Medtronic REF: MMT-7020D3 Guardian Sensor (3) for the following packaging: GS3 1 PK OUS3/ GTIN: 00643169704121 GS3 1PK 9L OUS3/ GTIN: 00763000318895 Product Usage: intended for use with Medtronic D
Open, Classified
MDSNone listed
Feb 26, 2021Medtronic Inc.
Medtronic REF: MMT-7020D2 Guardian Sensor (3) for the following packaging: GS3 1PK 9L OUS2/ GTIN: 00763000243357 GS3 1PK 9L OUS2/ GTIN: 00763000318871 Product Usage: intended for use with Medtronic
Open, Classified
MDSNone listed
Feb 26, 2021Medtronic Inc.
Medtronic REF: MMT-7020D1 Guardian Sensor (3) for the following packaging: GS3 1PK OUS1/ GTIN: 00643169704084 GS3 1PK 9L OUS1/ GTIN: 00763000243333 GS3 1PK 9L OUS1/ GTIN: 00763000318857 Product Usa
Open, Classified
MDSNone listed
Feb 26, 2021Medtronic Inc.
Medtronic REF: MMT-7020C5 Guardian Sensor (3) for the following packaging: GS3 5PK 1L AUS/ GTIN: 20763000252056 GS3 5PK 1L AUS/ GTIN: 20763000414362 Product Usage: intended for use with Medtronic D
Open, Classified
MDSNone listed
Feb 26, 2021Medtronic Inc.
Medtronic REF: MMT-7020C4 Guardian Sensor (3) for the following packaging: GS3 5PK 2L CANADA/ GTIN: 20763000179612 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensi
Open, Classified
MDSNone listed
Feb 26, 2021Medtronic Inc.
Medtronic REF: MMT-7020C3 Guardian Sensor (3) for the following packaging: GS3 5PK OUS3/ GTIN: 20643169704118 GS3 5PK 9L OUS3/ GTIN: 20763000243368 GS3 5PK 9L OUS3/ GTIN: 20763000318882 Product
Open, Classified
MDSNone listed
Feb 26, 2021Medtronic Inc.
Medtronic REF: MMT-7020C2 Guardian Sensor (3) for the following packaging: GS3 5PK 9L OUS2/ GTIN: 20763000243344 GS3 5PK 9L OUS2/ GTIN: 20763000318868 Product Usage: intended for use with Medtron
Open, Classified
MDSNone listed
Feb 26, 2021Medtronic Inc.
Medtronic REF: MMT-7020C1 Guardian Sensor (3) for the following packaging: GS3 5PK OUS1/ GTIN: 20643169704071 GS3 5PK 9L OUS1/ GTIN: 20763000243320 GS3 5PK 9L OUS1/ GTIN: 20763000318844 Product
Open, Classified
MDSNone listed
Feb 26, 2021Medtronic Inc.
Medtronic REF: MMT-7020C Guardian Sensor (3) kit for the following packaging: GS3 SEMI 5PK OUS/ GTIN: 20763000192086, 5PK SF NEW GS3 OUS/GTIN: 20763000358451 Product Usage: intended for use with
Open, Classified
MDSNone listed
Feb 26, 2021Medtronic Inc.
Medtronic REF: MMT-7020LB, Guardian Sensor (3) for the following packaging: GS3 1PK US/ GTIN: 763000336998 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing system
Open, Classified
MDSNone listed
Feb 26, 2021Medtronic Inc.
Medtronic REF: MMT-7020LA, Guardian Sensor (3) for the following packaging: GS3 5PK US/ GTIN: 20763000336985 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing syste
Open, Classified
MDSNone listed
Feb 26, 2021Medtronic Inc.
Medtronic REF: MMT-7020GA, Guardian Sensor (3) for the following packaging: GS3 5PK US GC/ GTIN: 20763000179629 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing s
Open, Classified
MDSNone listed
Feb 26, 2021Medtronic Inc.
Medtronic REF: MMT-7020B, Guardian Sensor (3) for the following packaging: GS3 1PK 2L US/GTIN: 00763000140779 GS3 1PK 2L US/ GTIN: 00763000337049 Product Usage: intended for use with Medtronic Di
Open, Classified
MDSNone listed
Feb 26, 2021Medtronic Inc.
Medtronic REF: MMT-7020A, Guardian Sensor (3) for the following packaging: GS3 5PK 2L US/ GTIN: 20763000140940 GS3 5PK 2L US/ GTIN: 20763000337005 Product Usage: intended for use with Medtronic Di
Open, Classified
MDSNone listed
Feb 26, 2021Medtronic Inc.
Medtronic REF: MMT-7008B, Enlite Glucose Sensor for the following packaging: ENLITE PLUS 23L 1CL / GTIN: 00643169541719 ENLITE PLUS 2L 1CL PR/ GTIN: 00643169786738 ENLITE PLUS 1PK 23L 1CL/ GTIN:
Open, Classified
MDSNone listed
Feb 26, 2021Medtronic Inc.
Medtronic, REF: MMT-7008A, Enlite Glucose Sensor for the following packaging: ENLITE PLUS 5PK 23L 1CL /GTIN: 20643169541706, ENLT PLUS 5PK 2L 1CL PR/ GTIN: 20643169786725, ENLITE PLUS 5PK 23L 1CL/ GTI
Open, Classified
MDSNone listed
Nov 12, 2020Medtronic Inc.
CareLink Personal Software Therapy Management Software Tool for Diabetes CareLink System Therapy Management Software Tool for Diabetes Software Uploader versions: 3.1.5.000 3.1.2.000
Open, Classified
MDSK151236
Jul 15, 2020Medtronic Inc.
The Guardian Connect App CSS7200 iOS - Product Usage: intended for use by patients with a compatible consumer mobile device.
Terminated
MDSNone listed
Feb 3, 2020Dexcom Inc
Dexcom G4 PLATINUM Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns
Terminated
MDSNone listed
Jul 12, 2019Dexcom Inc
Dexcom Receiver, REF: MT22719, (Black, Pin, Blue), Rx Only, containing software version SW10617 and revision 4.0.1.048 - Product Usage: A non-adjunctive invasive glucose sensor is intended to determi
Terminated
MDSNone listed
May 20, 2019Medtronic Inc.
Guardian Connect App CSS7200 iOS and Guardian Connect Transmitter GST4C used on the iPhone, iPad and iPod Touch devices.
Open, Classified
MDSNone listed
Jul 4, 2018Medtronic Inc.
Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices.
Terminated
MDSNone listed
Apr 11, 2016Dexcom Inc
Dexcom G5 Mobile Receiver Receiver Part Number: MT22719 Receiver (mg/dL), Black; MT22719-PNK, Receiver (mg/dL), Pink; MT22719-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose p
Terminated
MDSNone listed
Apr 11, 2016Dexcom Inc
Dexcom G4 PLATINUM (Pediatric) Receiver with Share Receiver Part Number: MT22608 Receiver (mg/dL), Black (pediatrics); MT22608-PNK, Receiver (mg/dL), Pink (pediatrics); MT22608-BLU, Receiver (mg/dL),
Terminated
MDSNone listed
Apr 11, 2016Dexcom Inc
Dexcom G4 PLATINUM Receiver with Share Receiver Part Number: MT22495 Receiver (mg/dL), Black; MT22495-PNK, Receiver (mg/dL), Pink; MT22495-BLU, Receiver (mg/dL), Blue. Intended to detect trends and tr
Terminated
MDSNone listed
Apr 11, 2016Dexcom Inc
Dexcom G4 PLATINUM (Professional) Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black. Intended to detect trends and track glucose patterns in persons with diabetes. The G4 PLATINUM CGM S
Terminated
MDSNone listed
Apr 11, 2016Dexcom Inc
Dexcom G4 PLATINUM (Pediatric) Receiver Receiver Part Number: MT22430 Receiver (mg/dL), Black (pediatrics); MT22430-PNK, Receiver (mg/dL), Pink (pediatrics); MT22430-BLU, Receiver (mg/dL); Blue (pedia
Terminated
MDSNone listed
Apr 11, 2016Dexcom Inc
Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose
Terminated
MDSNone listed
Aug 21, 2015Medtronic MiniMed Inc.
Guardian Real-Time Monitor, Model No. CSS7100. Indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, in adults (18 years and older) with diabetes mellitus, fo
Terminated
MDSNone listed
Aug 10, 2014Medtronic MiniMed Inc.
Medtronic MiniMed Guardian Monitor, Model No. CSS7100, CSS7100K Product Usage: The Medtronic MiniMed model CSS7100 and CSS7100K Guardian REAL-Time monitors are used in combination with the Minilink
Terminated
MDSNone listed
Apr 30, 2010Abbott Diabetes Care, Inc.
Freestyle Navigator Continuous Glucose Monitor System, Clinical Transmitter, Abbott Item Number: PRT 03831-091, distributed by Abbott Diabetes Care Inc, Alameda, CA. Medical device indicated for con
Terminated
MDSNone listed
Apr 30, 2010Abbott Diabetes Care, Inc.
Freestyle Navigator Continuous Glucose Monitor System, Assy, Transmitter Poly Contac, Abbott Item Number: PRT 03831-002, distributed by Abbott Diabetes Care Inc, Alameda, CA. Medical device indicated
Terminated
MDSNone listed
Apr 30, 2010Abbott Diabetes Care, Inc.
Freestyle Navigator Continuous Glucose Monitor System, ABB Transmitter Navigator. Abbott Item Number: PRT 03831-001, distributed by Abbott Diabetes Care Inc, Alameda, CA. Medical device indicated f
Terminated
MDSNone listed
Apr 30, 2010Abbott Diabetes Care, Inc.
Freestyle Navigator Continuous Glucose Monitor System, Clinical System Kit, Packaging. Abbott Item Number: PRT 03415-010, distributed by Abbott Diabetes Care Inc, Alameda, CA. Medical device indic
Terminated
MDSNone listed
Apr 30, 2010Abbott Diabetes Care, Inc.
Freestyle Navigator Continuous Glucose Monitor System, System Kit, Business 1, (Orange). Abbott Item Number: PRT 03415-001, distributed by Abbott Diabetes Care Inc, Alameda, CA. Medical device indi
Terminated
MDSNone listed
Apr 30, 2010Abbott Diabetes Care, Inc.
Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, System Kit MG EMEA and System Kit MMOL, EMEA. Abbott Item Number 71036-02, distributed by Abbott Diabetes Care Inc, Alameda
Terminated
MDSNone listed
Apr 30, 2010Abbott Diabetes Care, Inc.
Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, System Kit MMOL EMEA. Abbott Item Number 71036-01, distributed by Abbott Diabetes Care Inc, Alameda, CA. Medical device in
Terminated
MDSNone listed
Apr 30, 2010Abbott Diabetes Care, Inc.
Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, System Kit MMOL (EMEA) SV. Abbott Item Number 70966-04, distributed by Abbott Diabetes Care Inc, Alameda, CA. Medical device
Terminated
MDSNone listed
Apr 30, 2010Abbott Diabetes Care, Inc.
Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, System, Business 1, MMOL (EMEA) UK. Abbott Item Number 70966-03, distributed by Abbott Diabetes Care Inc, Alameda, CA. Medic
Terminated
MDSNone listed
Apr 30, 2010Abbott Diabetes Care, Inc.
Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, System, Business 1, MMOL. Abbott Item Number 70966-02, distributed by Abbott Diabetes Care Inc, Alameda, CA. Medical device
Terminated
MDSNone listed
Apr 30, 2010Abbott Diabetes Care, Inc.
Freestyle Navigator Continuous Glucose Monitor System, ABB NAV Dutch System Kit CE RE, AND ABB SYSTEM KIT, MMOL, EMEA AND ABB09 Dutch Kit New LCD. Abbot Item Number 70966-01, distributed by Abbott L
Terminated
MDSNone listed
Apr 30, 2010Abbott Diabetes Care, Inc.
Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, System Kit Business I, MG, and System Kit MG (EMEA) FR, PACK. Abbott Item Number 70965-03, distributed by Abbott Diabetes Car
Terminated
MDSNone listed
Apr 30, 2010Abbott Diabetes Care, Inc.
Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, System Kit Business I, MG,(E). Abbott Item Number 70965-02, distributed by Abbott Diabetes Care Inc, Alameda, CA. Medical dev
Terminated
MDSNone listed
Apr 30, 2010Abbott Diabetes Care, Inc.
Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, ABB System Kit MG, EMEA, DE. Abbott Item Number 70965-01, distributed by Abbott Diabetes Care Inc, Alameda, CA. Medical device
Terminated
MDSNone listed

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