17 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM reagent, when used in conjunction with IMMAGE Immunochemistry Systems and Calibrator 1, is intended for the quantitative determination of immunoglobulin M (IGM) in human serum by rate nephelometry.
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Inc.·October 23, 2024
IDM-MICRO-R. Electrical wheelchair component.
FDA Enforcement
Class I
·Ongoing·mo-Vis BVBA·September 10, 2025
IDM-ARLITE-R. Electrical wheelchair component.
FDA Enforcement
Class I
·Ongoing·mo-Vis BVBA·September 10, 2025
All-round Joystick R-net Light. Electrical wheelchair component.
FDA Enforcement
Class I
·Ongoing·mo-Vis BVBA·September 10, 2025
IDM-MULTI-R. Electrical wheelchair component.
FDA Enforcement
Class I
·Ongoing·mo-Vis BVBA·September 10, 2025
Micro Joystick R-net. Electrical wheelchair component.
FDA Enforcement
Class I
·Ongoing·mo-Vis BVBA·September 10, 2025
Multi Joystick R-net. Electrical wheelchair component.
FDA Enforcement
Class I
·Ongoing·mo-Vis BVBA·September 10, 2025
Scoot Control R-net, Product Number P015-61. The Scoot Control is intended to support a wheelchair attendant in controlling or maneuvering a power chair
FDA Enforcement
Class II
·Ongoing·mo-Vis BVBA·January 17, 2024
VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK¿ 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. Export only
FDA Enforcement
Class II
·Ongoing·bioMerieux, Inc.·October 8, 2025
Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use
FDA Enforcement
Class II
·Ongoing·Abbott Molecular, Inc.·November 30, 2022
TTDEYE (brand) Radial Pink, B16112110 - Product Usage: Colored contact lenses
FDA Enforcement
Class II
·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020
TTDEYE (brand) Devil Red, B16112201 - Product Usage: Colored contact lenses
FDA Enforcement
Class II
·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020
TTDEYE (brand) Radial Brown, B16112109 - Product Usage: Colored contact lenses
FDA Enforcement
Class II
·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020
TTDEYE (brand) Black Starshine, B16112100 - Product Usage: Colored contact lenses
FDA Enforcement
Class II
·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020
TTDEYE (brand) Diamonds Starlight, B16112203 - Product Usage: Colored contact lenses
FDA Enforcement
Class II
·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020
TTDEYE (brand) Flower Grey, B16112231 - Product Usage: Colored contact lenses
FDA Enforcement
Class II
·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020
TTDEYE (brand) Flower Brown, B16112210 - Product Usage: Colored contact lenses
FDA Enforcement
Class II
·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020