13 results
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16ms
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Sources: EU EUDAMED, US FDA
Alcon Air Optix Night & Day Aqua (lotrafilcon A), breathable contact lenses, PWR - 1.50 BC 8.6 DIA 13.8, Rx, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX.
FDA Enforcement
Class II
·Completed·Lens.com·December 11, 2019
MiniCap with Povidone-Iodine Solution, item number 5C4466P, for hemodialysis.
FDA Enforcement
Class II
·Completed·Baxter Healthcare Corp.·March 25, 2015
Applied Medical Technology, Inc., NutraGlide, 5 f - 6F x 55 Nasal Feeding Tube with Stylet and ENfit, REF NFT-05055-I
FDA Enforcement
Class II
·Completed·Applied Medical Technology Inc·November 19, 2025
Applied Medical Technology, Inc., NutraGlide, 6 F- 8 F x 90 Nasal Feeding Tube with Stylet and ENfit, REF NFT-06090-I
FDA Enforcement
Class II
·Completed·Applied Medical Technology Inc·November 19, 2025
Immundiagnostik IDK Lactoferrin ELISA- In vitro enzyme immunoassay intended for the determination of lactoferrin in stool. P/N: K6870 Single Kit P/N: K6870.20.US.L 20 Plates
FDA Enforcement
Class II
·Completed·IMMUNDIAGNOSTIK, Inc·May 24, 2023
Applied Medical Technology, Inc., NutraGlide, 5 F- 6 F x 90 Nasal Feeding Tube with Stylet and ENfit, REF NFT-05090-I
FDA Enforcement
Class II
·Completed·Applied Medical Technology Inc·November 19, 2025
Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves
FDA Enforcement
Class II
·Completed·Cardinal Health 200, LLC·April 20, 2022
Applied Medical Technology, Inc., NutraGlide, 5 F- 6 F x 55 Nasal Feeding Tube with Stylet and ENfit, REF NFT-05055-N-I
FDA Enforcement
Class II
·Completed·Applied Medical Technology Inc·November 19, 2025
Applied Medical Technology, Inc., NutraGlide, 6 F- 8 F x 55 Nasal Feeding Tube with Stylet and ENfit, REF NFT-06055-I
FDA Enforcement
Class II
·Completed·Applied Medical Technology Inc·November 19, 2025
AMT Initial Placement Dilator Set. Used to place gastrostomy devices.
FDA Enforcement
Class II
·Completed·Applied Medical Technology Inc·July 10, 2024
greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, non-ridged, 24 racks of 50 pcs., 1200 pcs in total, Item #456003
FDA Enforcement
Class II
·Completed·Greiner Bio-One North America, Inc.·May 24, 2023
VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-results VERIGENE System; invitro diagnostic test
FDA Enforcement
Class II
·Completed·Luminex Corporation·June 11, 2025
AMT Mini Enteral Extension Set, 12" Right Angle Feeding Set with Y-Port. Model/Catalog Number: E6-1222
FDA Enforcement
Class II
·Completed·Applied Medical Technology Inc·January 15, 2025