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)
Top companies in MDS
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic Inc. | 0 | 24 |
| Abbott Diabetes Care, Inc. | 0 | 21 |
| Dexcom Inc | 0 | 8 |
| Medtronic MiniMed | 0 | 4 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 2, 2025 | Medtronic MiniMed, Inc. Medtronic, Simplera Sensor, REF: MMT-5100JD1 Open, Classified |
MDS | None listed |
| Jan 1, 2023 | Medtronic MiniMed Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system Open, Classified |
MDS | None listed |
| Feb 26, 2021 | Medtronic 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 |
MDS | None listed |
| Feb 26, 2021 | Medtronic 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 |
MDS | None listed |
| Feb 26, 2021 | Medtronic 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 |
MDS | None listed |
| Feb 26, 2021 | Medtronic 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 |
MDS | None listed |
| Feb 26, 2021 | Medtronic 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 |
MDS | None listed |
| Feb 26, 2021 | Medtronic 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 |
MDS | None listed |
| Feb 26, 2021 | Medtronic 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 |
MDS | None listed |
| Feb 26, 2021 | Medtronic 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 |
MDS | None listed |
| Feb 26, 2021 | Medtronic 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 |
MDS | None listed |
| Feb 26, 2021 | Medtronic 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 |
MDS | None listed |
| Feb 26, 2021 | Medtronic 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 |
MDS | None listed |
| Feb 26, 2021 | Medtronic 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 |
MDS | None listed |
| Feb 26, 2021 | Medtronic 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 |
MDS | None listed |
| Feb 26, 2021 | Medtronic 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 |
MDS | None listed |
| Feb 26, 2021 | Medtronic 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 |
MDS | None listed |
| Feb 26, 2021 | Medtronic 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 |
MDS | None listed |
| Feb 26, 2021 | Medtronic 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 |
MDS | None listed |
| Feb 26, 2021 | Medtronic 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 |
MDS | None listed |
| Feb 26, 2021 | Medtronic 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 |
MDS | None listed |
| Feb 26, 2021 | Medtronic 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 |
MDS | None listed |
| Nov 12, 2020 | Medtronic 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 |
MDS | K151236 |
| Jul 15, 2020 | Medtronic Inc. The Guardian Connect App CSS7200 iOS - Product Usage: intended for use by patients with a compatible consumer mobile device. Terminated |
MDS | None listed |
| Feb 3, 2020 | Dexcom 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 |
MDS | None listed |
| Jul 12, 2019 | Dexcom 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 |
MDS | None listed |
| May 20, 2019 | Medtronic Inc. Guardian Connect App CSS7200 iOS and Guardian Connect Transmitter GST4C used on the iPhone, iPad and iPod Touch devices. Open, Classified |
MDS | None listed |
| Jul 4, 2018 | Medtronic Inc. Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices. Terminated |
MDS | None listed |
| Apr 11, 2016 | Dexcom 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 |
MDS | None listed |
| Apr 11, 2016 | Dexcom 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 |
MDS | None listed |
| Apr 11, 2016 | Dexcom 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 |
MDS | None listed |
| Apr 11, 2016 | Dexcom 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 |
MDS | None listed |
| Apr 11, 2016 | Dexcom 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 |
MDS | None listed |
| Apr 11, 2016 | Dexcom 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 |
MDS | None listed |
| Aug 21, 2015 | Medtronic 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 |
MDS | None listed |
| Aug 10, 2014 | Medtronic 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 |
MDS | None listed |
| Apr 30, 2010 | Abbott 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 |
MDS | None listed |
| Apr 30, 2010 | Abbott 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 |
MDS | None listed |
| Apr 30, 2010 | Abbott 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 |
MDS | None listed |
| Apr 30, 2010 | Abbott 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 |
MDS | None listed |
| Apr 30, 2010 | Abbott 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 |
MDS | None listed |
| Apr 30, 2010 | Abbott 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 |
MDS | None listed |
| Apr 30, 2010 | Abbott 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 |
MDS | None listed |
| Apr 30, 2010 | Abbott 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 |
MDS | None listed |
| Apr 30, 2010 | Abbott 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 |
MDS | None listed |
| Apr 30, 2010 | Abbott 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 |
MDS | None listed |
| Apr 30, 2010 | Abbott 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 |
MDS | None listed |
| Apr 30, 2010 | Abbott 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 |
MDS | None listed |
| Apr 30, 2010 | Abbott 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 |
MDS | None listed |
| Apr 30, 2010 | Abbott 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 |
MDS | None listed |
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