6 results
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13ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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a. MMS - IMMUNOSTICS INC McKesson Rapid Test Kit Consult Colorectal Cancer Screening Fecal Occult Blood Test (iFOB or FIT) Stool Sample 25 Tests, Model Number: 4487. b. MMS - IMMUNOSTICS INC McKesson Rapid Test Kit McKesson Consult Colorectal Cancer Screening Fecal Occult Blood Test (FOBT) Stool Sample 100 Tests Model Number: 4487. c. MMS - IMMUNOSTICS INC McKesson Rapid Test Kit McKesson Consult Colorectal Cancer Screening Fecal Occult Blood Test (FOBT) Stool Sample 50 Tests Model Number: 127-50ER
FDA Enforcement
Class II
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·August 31, 2022
VS3 Iridium - Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS) - 785nm Product Number: 175-0012
FDA Enforcement
Class II
·Ongoing·Visionsense, Ltd.·November 30, 2022
VS3 Iridium Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS-IR) Product Number: 174-0012
FDA Enforcement
Class II
·Ongoing·Visionsense, Ltd.·November 30, 2022
Burlington Medical, Wrap Aprons.
FDA Enforcement
Class II
·Ongoing·Burlington Medical, LLC·April 8, 2026
MICRO-X Rover Mobile X-ray System, # MXU-RV35
FDA Enforcement
Class II
·Ongoing·Micro-X Ltd.·December 18, 2024
NxStage Cartridge Express with Speedswap, Catalog No. CAR-535. An accessory device for facilitating the removal and replacement of a flow-compromised filter during treatment of acute and chronic renal failure or fluid overload.
FDA Enforcement
Class II
·Ongoing·NxStage MDS Corporation·March 6, 2024