BEUDAMED
    102 results · 35ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Enforcement ×

    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 Sets The Paradigm infusion sets are intended for use with Paradigm insulin infusion pumps.

    FDA Enforcement
    Class I ·Terminated·Medtronic MiniMed·July 17, 2013

    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

    CareLink Pro Medtronic CareLink Pro MMT-7335 is a personal computer software application designed to enhance Health Care Provider management of diabetic patients using Medtronic insulin pumps and blood glucose meters. MMT-7335 is intended for use by Health Care Providers/Physicians as a therapy management accessory to: - read and store history and settings data supported insulin pump models and supported blood glucose meters - read and report user-programmable settings on supported pump models - read device data from the CareLink Online system - write new device data to the CareLink system - generate reports from the patient records for use in managing the patient's therapy. CareLink Clinical Medtronic CareLink MMT-7334 is a network based software system residing on a computer server platform connected to the Internet. The system is designed to upload patient data from Medtronic MiniMed insulin pumps and supported third-party blood glucose meters to the MMT-7334 central database via a client PC (Personal Computer), which connects to supported devices. The data contained in MMT-7334 is accessible to users using a standard browser, i.e. Microsoft Internet Explorer, on a PC that is connected to the Internet. The user may view and print various reports generated from the device data uploaded to MMT-7334, plus additional information provided by the user. The product does not provide any medical advice to patients or physicians. This is currently only intended to be used in Clinical Trials. Both products are CD ROMs.

    FDA Enforcement
    Class III ·Terminated·Medtronic MiniMed Inc.·March 11, 2015

    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