7 results
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17ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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VIDAS Lyme IgM II (LYM), REF 416436
FDA Enforcement
Class II
·Ongoing·bioMerieux, Inc.·January 5, 2022
VIDAS Lyme IgG II (LYM), REF 417401
FDA Enforcement
Class II
·Ongoing·bioMerieux, Inc.·January 5, 2022
Model No:T-SPOT.TB8, Catalogue No.: TB.300; UDI: 1505171600030 - Product Usage: intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection by detecting effector T cells that respond to stimulation by M. tuberculosis antigens ESAT-6 and CFP10, and capturing interferon-gamma in the vicinity of these cells.
FDA Enforcement
Class III
·Terminated·Oxford Immunotec·September 23, 2020
Model No:T-SPOT.TB50, Catalogue No.: TB.50; UDI: 1505171600004 - Product Usage: intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection by detecting effector T cells that respond to stimulation by M. tuberculosis antigens ESAT-6 and CFP10, and capturing interferon-gamma in the vicinity of these cells.
FDA Enforcement
Class III
·Terminated·Oxford Immunotec·September 23, 2020
Box Label: activ5 TINY GYM IN YOUR POCKET activbody Model: Activ5 User Manual: ACTIV5 USER MANUAL Welcome to Activ5, the first isometrics-based smart strength training and rehabilitation device.
FDA Enforcement
Class II
·Ongoing·Activbody, Inc.·December 22, 2021
MIM software; System, Image Processing, Radiological
FDA Enforcement
Class II
·Ongoing·MIM Software Inc·March 12, 2025
The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range.
FDA Enforcement
Class II
·Ongoing·IN MY BATHROOM LLC·October 12, 2022