93 results
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14ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Medtronic MiniMed 630G 6025805-003_C, Rx Only Medtronic MiniMed 670G 6025805-005_B, Rx Only Medtronic MiniMed 640G (International)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·January 2, 2019
MiniMed 780G Insulin Pump (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896)
FDA Enforcement
Class II
·Ongoing·Medtronic MiniMed, Inc.·April 8, 2026
Medtronic MiniMed Paradigm Insulin Infusion Pumps, Paradigm models: MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-715, MMT-522, MMT-522K, MMT-722, MMT-722K, MMT-523, MMT-523K, MMT-723, MMT-723K, MMT-554, and MMT-754. MiniMed 530G: MMT-551, and MMT-751 Paradigm insulin infusion pumps are intended for use to deliver basal and bolus insulin to persons with diabetes.
FDA Enforcement
Class II
·Terminated·Medtronic MiniMed Inc.·September 3, 2014
Medtronic MiniMed(TM) Pro-set(TM) (MMT-280, 281)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017
Medtronic MiniMed Implantable Insulin Pump, Model No. MMT-2007D
FDA Enforcement
Class II
·Terminated·Medtronic MiniMed Inc.·August 20, 2014
Medtronic MiniMed Silhouette and/or MiniMed Sure-T Infusion Sets; Paradigm Silhouette infusion sets: MMT-368, MMT-368600, MMT-371, MMT-373, MMT-377, MMT-377600, MMT378, MMT-378600, MMT-38 1, MMT-381 600, MMT-382, MMT-382600, MMT-383, MMT-383600, MMT384, & MMT384600. Sure-T infusion sets MMT-862, MMT-863, MMT-864, MMT-865, MMT-866, MMT-873, MMT-874, MMTMMT-875, MMT-876, MMT-884, & MMT-886. MiniMed Duo sensor/infusion sets: MMT-5001A23, MMT-5001A43, MMT-5001B23, MMT-5001B43, MMT-5011A23, MMT-5011A43, MMT-5011B23, & MMT-5011B43. Silhouette and Sure-T disposable infusion sets are used with Medtronic insulin infusion pumps using Paradigm P-cap connectors. The infusion set connects the insulin reservoir in the pump to the patients body.
FDA Enforcement
Class II
·Terminated·Medtronic MiniMed Inc.·December 17, 2014
Medtronic MiniMed(TM) Sure-T(TM) (MMT-862, 862T, 864, 864T, 866, 866T, 874, 874T, 876, 876T, 884, 886, 886T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017
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 transmitter and Sof-sensor glucose sensor for continuous monitoring of subcutaneous glucose concentration. The information provided by these devices is intended for use in identifying potential episodes of high or low blood glucose. The information provided is not intended to be used directly for making therapy adjustment but rather to assist the user in determining that an additional fingerstick glucose measurement may be appropriate. Per the product labeling, all therapy adjustments should be based on fingerstick glucose measurements obtained using standard home glucose meters and not on the sensor glucose values provided by the Guardian REAL-Time monitor. The CSS7100 and CSS7100K monitors are identical expect for the fact that the CSS7100K monitor is a pediatric version that has a minimum programmable low alert setting of 90 mg/dL. The minimum programmable low glucose alert setting for the adult model (CSS7100) is 40 mg/dL.
FDA Enforcement
Class II
·Terminated·Medtronic MiniMed Inc.·August 20, 2014
Medtronic MiniMed Paradigm Reservoirs, Model No: MMT-326A (1.8mL) and MMT-332A (3.0mL) The model MMT-326A and MMT-332A are syringe type insulin reservoirs intended for use with Medtronic Paradigm series insulin infusion pumps. The two reservoirs are identical except for barrel length and as a result, maximum insulin capacity. The MMT-326A holds a maximum of 1.8ml of insulin whereas the longer MMT-332A reservoir can hold up to 3.0ml of insulin. Both reservoirs are supplied sterile and are labeled for single use. Typically, the reservoir is replaced every tow or three days at the time of infusion set replacement. The Paradigm reservoirs have a shelf life of three years post sterilization. Product Quantity Distributed (Int) 669,672 units
FDA Enforcement
Class II
·Terminated·Medtronic MiniMed·August 28, 2013
Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K
FDA Enforcement
Class II
·Ongoing·Medtronic MiniMed·April 1, 2020
Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K
FDA Enforcement
Class II
·Ongoing·Medtronic MiniMed·April 1, 2020
Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
FDA Enforcement
Class II
·Ongoing·Medtronic MiniMed·April 1, 2020
Medtronic MiniMed Paradigm Insulin pump, model number MMT-722K
FDA Enforcement
Class II
·Ongoing·Medtronic MiniMed·April 1, 2020
Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
FDA Enforcement
Class II
·Ongoing·Medtronic MiniMed·April 1, 2020
Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
FDA Enforcement
Class II
·Ongoing·Medtronic MiniMed·April 1, 2020
Medtronic MiniMed Paradigm Insulin pump, model number MMT-523
FDA Enforcement
Class II
·Ongoing·Medtronic MiniMed·April 1, 2020
Medtronic MiniMed Paradigm Insulin pump, model number MMT-712E
FDA Enforcement
Class II
·Ongoing·Medtronic MiniMed·April 1, 2020
Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
FDA Enforcement
Class II
·Ongoing·Medtronic MiniMed·April 1, 2020
MiniMed NGP 640G 1.8ml (mmol/L), Model No. MMT-1511; NGP 640G 1.8ml (mg/dL), Model No. 1512; NGP 640G PLGM 3ml (mmol/L), Model No. MMT-1711; NGP 640G PLGM 3ml (mg/dL), Model No. MMT-1712.
FDA Enforcement
Class II
·Terminated·Medtronic MiniMed Inc.·August 5, 2015
BD FlowSmart Set MiniMed Pro-set Rx Only Distributed by Medtronic MiniMed Inc. 8006464633 8185765555 Legal Manufacturer Becton, Dickinson and Company USA BD Medical-Diabetes Care Becton Dickinson France SAS
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·May 10, 2017