22 results
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17ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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MED-810A Zemits NDPrime Laser products
FDA Enforcement
Class II
·Ongoing·Advance-Esthetic LLC·October 18, 2023
Option"ELITE Vena Cava Filter System REF 352506070E UDI-DI code: 00886333217151 The Option"ELITE Filter is indicated for the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the inferior vena cava (IVC) in the following conditions: " Pulmonary thromboembolism when anticoagulants are contraindicated " Failure of anticoagulant therapy in thromboembolic disease " Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced " Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated
FDA Enforcement
Class II
·Ongoing·Argon Medical Devices, Inc·December 3, 2025
Model: Incisive CT for Brazil SKD; Product Code (REF): 728146; Software Versions: 5.1.0.X & 5.1.1.X;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS·November 5, 2025
Model: Incisive CT; Product Code (REF): (1) 728143, (2) 728144; Software Versions: 5.1.0.X & 5.1.1.X;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS·November 5, 2025
Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.1.1.X;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS·November 5, 2025
MiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software Version 6.60 The MiniMed 780G insulin pump is indicated for use by patients age 7-80 years with Type 1 diabetes, whose total daily dose of insulin is 8 units per day or more. The MiniMed 780G system is intended for continuous delivery of basal insulin at selectable rates, and the administration of insulin boluses at selectable amounts for the management of type 1 diabetes mellitus in persons seven years of age and older requiring insulin. The system is also intended to continuously monitor glucose values in the fluid under the skin. The MiniMed 780G system includes SmartGuard technology, which can be programmed to automatically adjust insulin delivery based on continuous glucose monitoring (CGM) sensor glucose values and can suspend delivery of insulin when the SG value falls below or is predicted to fall below predefined threshold values.
FDA Enforcement
Class II
·Ongoing·Medtronic MiniMed, Inc.·February 11, 2026
FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Continuous Glucose Monitoring System
FDA Enforcement
Class I
·Ongoing·Abbott Diabetes Care, Inc.·September 4, 2024
ARIES Extraction Kit; ARIES System; SYNCT , REF 50-10026, UDI # 00840487100073
FDA Enforcement
Class II
·Ongoing·Luminex Corporation·August 21, 2019
ARIES SARS-CoV-2 Assay
FDA Enforcement
Class II
·Ongoing·Luminex Corporation·August 24, 2022
Aries Bordetella Assay, REF 50-10037, UDI # 00840487101452
FDA Enforcement
Class II
·Ongoing·Luminex Corporation·August 21, 2019
ARIES GBS Assay , REF 50-10021, UDI # 00840487100165
FDA Enforcement
Class II
·Ongoing·Luminex Corporation·August 21, 2019
ARIES SARS-CoV-2 Assay, REF: 50-10047
FDA Enforcement
Class II
·Ongoing·Luminex Corporation·November 2, 2022
ARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059
FDA Enforcement
Class II
·Ongoing·Luminex Corporation·August 21, 2019
ARIES HSV 1&2 Assay , REF 50-10017, UDI # 00840487100295
FDA Enforcement
Class II
·Ongoing·Luminex Corporation·August 21, 2019
ARIES Group A Strep Assay , REF 50-10041, UDI # 00840487101469
FDA Enforcement
Class II
·Ongoing·Luminex Corporation·August 21, 2019
ARIES Flu A/B & RSV Assay , REF 50-10020, UDI # 00840487100158
FDA Enforcement
Class II
·Ongoing·Luminex Corporation·August 21, 2019
HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144
FDA Enforcement
Class II
·Ongoing·Mizuho OSI·August 31, 2022
Mizuho CE IPX4, mode MOT-5602BW, 100-240, 50-60Hz, 400VA, REF 18-140-20 containing hand control Unit - Product Usage: intended to support a patient during surgical operations.
FDA Enforcement
Class II
·Ongoing·Mizuho OSI·March 31, 2021
Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may have been sold as an optional accessory for Sensititre Aris HIQ system YV4000-VZ
FDA Enforcement
Class II
·Ongoing·Remel, Inc·March 26, 2025
UFSK Treatment chair 500 XLE- Treatment chair for positioning and support of the patient during diagnostic and therapeutic treatments of temporary to short-term duration, especially in ophthalmology Art.no. / REF no.: 15000004 Art.no. / REF no.: 15000006
FDA Enforcement
Class II
·Ongoing·UFSK - International OSYS Gmbh·July 26, 2023