| MiniMed 670G System (P160017/S133) | Medtronic Minimed, Inc. | 2025-12-18 |
| MiniMed 780G System (P160017/S125) | Medtronic Minimed, Inc. | 2025-12-11 |
| MiniMed 670G system MiniMed 770G system MiniMed 780G system (P160017/S131) | Medtronic Minimed, Inc. | 2025-12-10 |
| Simplera Sync Sensor; Guardian 4 Sensor (P250012/S005) | Medtronic Minimed, Inc. | 2025-12-10 |
| MiniMed 780G System (P160017/S134) | Medtronic Minimed, Inc. | 2025-12-08 |
| Simplera Sync Sensor (P250012/S007) | Medtronic Minimed, Inc. | 2025-12-08 |
| Simplera System (P160007/S059) | Medtronic Minimed | 2025-12-08 |
| Simplera Sync Sensor (P250012/S006) | Medtronic Minimed, Inc. | 2025-12-05 |
| MiniMed 780G System (P160017/S132) | Medtronic Minimed, Inc. | 2025-12-05 |
| Simplera System (P160007/S057) | Medtronic Minimed | 2025-12-05 |
| Medtronic MiniMed 630G System (P150001/S110) | Medtronic Minimed | 2025-10-16 |
| Simplera Sync Sensor, Guardian 4 Sensor (P250012/S004) | Medtronic Minimed, Inc. | 2025-10-16 |
| MiniMed 670G System; MiniMed 770G System; MiniMed 780G System (P160017/S130) | Medtronic Minimed, Inc. | 2025-10-16 |
| Guardian Connect System Simplera System (P160007/S056) | Medtronic Minimed | 2025-10-16 |
| MiniMed 780G System (P160017/S127) | Medtronic Minimed, Inc. | 2025-10-09 |
| Guardian Connect System (P160007/S054) | Medtronic Minimed | 2025-10-09 |
| Guardian 4 Sensor (P250012/S002) | Medtronic Minimed, Inc. | 2025-10-09 |
| MiniMed 670G System (P160017/S129) | Medtronic Minimed, Inc. | 2025-10-02 |
| Simplera Sync Sensor, Guardian 4 Sensor (P250012/S003) | Medtronic Minimed, Inc. | 2025-09-12 |
| MiniMed 780G System (P160017/S128) | Medtronic Minimed, Inc. | 2025-09-12 |
| Simplera System (P160007/S055) | Medtronic Minimed | 2025-09-12 |
| MiniMed 780G System (P160017/S124) | Medtronic Minimed, Inc. | 2025-08-29 |
| Guardian Connect system (P160007/S053) | Medtronic Minimed | 2025-08-25 |
| MiniMed 670G System (P160017/S126) | Medtronic Minimed, Inc. | 2025-08-25 |
| Simplera Sync Sensor, Guardian 4 Sensor (P250012/S001) | Medtronic Minimed, Inc. | 2025-08-25 |
| MiniMed 770G System (P160017/S122) | Medtronic Minimed, Inc. | 2025-08-20 |
| Simplera Sync Sensor, Guardian 4 Sensor (P250012) | Medtronic Minimed, Inc. | 2025-08-06 |
| 13C-Gastric Emptying Breath Test (GEBT), 13C-Spirulina Gastric Emptying Breath Test (GEBT), 13C-GEBT (P110015/S011) | Advanced Breath Diagnostics | 2025-07-21 |
| FreeStyle Libre 14-Day Flash Glucose Monitoring System (P160030/S057) | Abbott Diabetes Care, Inc. | 2025-07-11 |
| FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S060) | Abbott Diabetes Care, Inc. | 2025-07-11 |
| MiniMed 770G Insulin Pump; MiniMed 780G Insulin Pump (P160017/S123) | Medtronic Minimed, Inc. | 2025-05-09 |
| MiniMed 780G System (P160017/S118) | Medtronic Minimed, Inc. | 2025-04-18 |
| EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM (P160048/S029) | Senseonics, Incorporated | 2025-03-27 |
| Eversense E3 Continuous Glucose Monitoring System, Eversense E3 Sensor, Eversense Insertion Tools, Eversense Smart Trans (P160048/S028) | Senseonics, Incorporated | 2024-10-23 |
| MiniMed 780G System (P160017/S121) | Medtronic Minimed, Inc. | 2024-10-10 |
| MiniMed 780G System (P160017/S120) | Medtronic Minimed, Inc. | 2024-10-07 |
| Simplera (TM) System (P160007/S052) | Medtronic Minimed | 2024-09-17 |
| Simplera System (P160007/S047) | Medtronic Minimed | 2024-07-24 |
| Guardian 4 Sensor (P160007/S051) | Medtronic Minimed | 2024-07-17 |
| Guardian 4 Sensor (P160017/S119) | Medtronic Minimed, Inc. | 2024-07-17 |
| Medtronic MiniMed 780G insulin pump (MMT-1884), Medtronic MiniMed 780G insulin pump kit (MMT-1894) (P160017/S116) | Medtronic Minimed, Inc. | 2024-04-19 |
| FreeStyle Libre 14 day Flash Glucose Monitoring System (P160030/S056) | Abbott Diabetes Care, Inc. | 2024-04-05 |
| MiniMed 670G Pump, MiniMed 770G Pump, Guardian Link (3) Transmitter, Guardian Sensor (3), Contour Next Link 2.4 Meter, R (P160017/S117) | Medtronic Minimed, Inc. | 2024-03-21 |
| Eversense E3 Continuous Glucose Monitoring System (CGM System) - Entire System, Eversense E3 Sensor, Eversense E3 Insert (P160048/S027) | Senseonics, Incorporated | 2024-02-22 |
| G5 Mobile Continuous Glucose Monitoring System, G6 Continuous Glucose Monitoring System, G7 Continuous Glucose Monitorin (P120005/S091) | Dexcom, Inc. | 2024-01-09 |
| Guardian Sensor 3, Guardian 4 Sensor (P160017/S115) | Medtronic Minimed, Inc. | 2024-01-05 |
| Guardian Sensor 3 (P160007/S050) | Medtronic Minimed | 2024-01-05 |
| Guardian Sensor 3 (P150001/S109) | Medtronic Minimed | 2024-01-05 |
| Guardian Sensor 3, Guardian 4 Sensor (P160017/S114) | Medtronic Minimed, Inc. | 2024-01-03 |
| Guardian Sensor 3 (P150001/S108) | Medtronic Minimed | 2024-01-03 |
| Guardian Sensor 3 (P160007/S049) | Medtronic Minimed | 2024-01-03 |
| Eversense E3 Continuous Glucose Monitoring System (CGM System) - Entire System, Eversense E3 Sensor, Eversense E3 Insert (P160048/S026) | Senseonics, Incorporated | 2023-12-05 |
| FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S059) | Abbott Diabetes Care, Inc. | 2023-11-21 |
| FreeStyle Libre 14 day Flash Glucose Monitoring System (P160030/S055) | Abbott Diabetes Care, Inc. | 2023-11-21 |
| MiniMed 670G system, MiniMed 770G system and MiniMed 780G system (P160017/S113) | Medtronic Minimed, Inc. | 2023-10-30 |
| MiniMed 630G system (P150001/S107) | Medtronic Minimed | 2023-10-30 |
| Guardian 4 Sensor (P160017/S111) | Medtronic Minimed, Inc. | 2023-07-06 |
| FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S058) | Abbott Diabetes Care, Inc. | 2023-06-30 |
| FreeStyle Libre 14 day Flash Glucose Monitoring System (P160030/S053) | Abbott Diabetes Care, Inc. | 2023-06-30 |
| MiniMed 780G System (P160017/S110) | Medtronic Minimed, Inc. | 2023-06-15 |
| Eversense E3 Continuous Glucose Monitoring System (CGM System) - Entire System, Eversense E3 Sensor, Eversense E3 Insert (P160048/S025) | Senseonics, Incorporated | 2023-06-09 |
| 13C-Spirulina Gastric Emptying Breath Test (GEBT) (P110015/S009) | Advanced Breath Diagnostics | 2023-05-19 |
| Eversense E3 CGM System (P160048/S024) | Senseonics, Incorporated | 2023-05-10 |
| MiniMed 770G System (P160017/S093) | Medtronic Minimed, Inc. | 2023-04-27 |
| MiniMed 780G System (P160017/S091) | Medtronic Minimed, Inc. | 2023-04-21 |
| MiniMed 670G System (P160017/S108) | Medtronic Minimed, Inc. | 2023-04-18 |
| MiniMed 630G System (P150001/S104) | Medtronic Minimed | 2023-04-18 |
| Eversense® E3 Continuous Glucose Monitoring (CGM) System (P160048/S022) | Senseonics, Incorporated | 2023-03-30 |
| Eversense® E3 Continuous Glucose Monitoring (CGM) System (P160048/S021) | Senseonics, Incorporated | 2023-03-29 |
| Eversense E3 Continuous Glucose Monitoring System (CGM System) - Entire System, Eversense E3 Sensor, Eversense E3 Insert (P160048/S023) | Senseonics, Incorporated | 2023-03-22 |
| Medtronic MiniMed 630G System (MM630G) (P150001/S105) | Medtronic Minimed | 2023-03-13 |
| Medtronic MiniMed 670G System (MM670G), Medtronic MiniMed 770G System (MM770G) (P160017/S109) | Medtronic Minimed, Inc. | 2023-03-13 |
| FreeStyle Libre 14-day Flash Glucose Monitoring System (P160030/S052) | Abbott Diabetes Care, Inc. | 2023-01-17 |
| DEXCOM G5 Mobile Continuous Glucose Monitoring System (P120005/S090) | Dexcom, Inc. | 2023-01-12 |
| MiniMed 630G System (P150001/S102) | Medtronic Minimed | 2022-12-16 |
| Guardian Sensor 3 (P160017/S096) | Medtronic Minimed, Inc. | 2022-12-16 |
| Guardian Sensor 3 (P160007/S043) | Medtronic Minimed | 2022-12-16 |
| MiniMed 670G System, MiniMedTM 770G System (P160017/S106) | Medtronic Minimed, Inc. | 2022-12-16 |
| Guardian Sensor 3 (P150001/S094) | Medtronic Minimed | 2022-12-16 |
| MiniMed Enlite Sensor (P120010/S142) | Medtronic, Inc. | 2022-12-08 |
| MiniMed 630G System with SmartGuard, MiniMed 630G System with GS3, GS3 Transfer to MPROC (P150001/S101) | Medtronic Minimed | 2022-12-08 |
| Medtronic MiniMed 670G System, GS3 Transfer to MPROC, Medtronic MiniMed 770G System, Medtronic MiniMed 780G System (P160017/S105) | Medtronic Minimed, Inc. | 2022-12-08 |
| Guardian Connect System (P160007/S046) | Medtronic Minimed | 2022-12-08 |
| MiniMed 770G Insulin Pump (P160017/S103) | Medtronic Minimed, Inc. | 2022-10-27 |
| Medtronic MiniMed 670G System, Medtronic MiniMed 770G System (P160017/S102) | Medtronic Minimed, Inc. | 2022-10-17 |
| Medtronic MiniMed 630G System with SmartGuard (P150001/S099) | Medtronic Minimed | 2022-10-17 |
| 13C-Gastric Emptying Breath Test (GEBT), 13C-Spirulina Gastric Emptying Breath Test (GEBT), 13C-GEBT (P110015/S010) | Advanced Breath Diagnostics | 2022-06-01 |
| Eversense E3 Continuous Glucose Monitoring System (P160048/S019) | Senseonics, Incorporated | 2022-05-24 |
| Eversense E3 Continuous Glucose Monitoring System (P160048/S018) | Senseonics, Incorporated | 2022-05-04 |
| Enlite Sensor (MMT-7008) (P150019/S065) | Medtronic Minimed | 2022-04-29 |
| Guardian Sensor (3) (MMT-7020) (P160007/S044) | Medtronic Minimed | 2022-04-29 |
| Enlite Sensor (MMT-7008) (P120010/S141) | Medtronic, Inc. | 2022-04-29 |
| Guardian Sensor (3) (MMT-7020), Enlite Sensor (MMT-7008) (P150001/S098) | Medtronic Minimed | 2022-04-29 |
| Guardian Sensor (3) (MMT-7020) (P160017/S100) | Medtronic Minimed, Inc. | 2022-04-29 |
| Enlite Sensor (MMT-7008) (P150029/S038) | Medtronic Minimed | 2022-04-29 |
| FreeStyle Libre 14 day Flash Glucose Monitoring System (P160030/S051) | Abbott Diabetes Care, Inc. | 2022-04-28 |
| Medtronic MiniMed 630G System (P150001/S097) | Medtronic Minimed | 2022-04-28 |
| Medtronic MiniMed 630G insulin pump (P150001/S096) | Medtronic Minimed | 2022-04-28 |
| FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S057) | Abbott Diabetes Care, Inc. | 2022-04-28 |
| Medtronic MiniMed 670G System (P160017/S099) | Medtronic Minimed, Inc. | 2022-04-28 |