10 results · 7ms · Sources: EU EUDAMED, US FDA

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CarePoint 60 mL Syringe Without Needle, REF: 04-7560

FDA Enforcement
Class II ·Completed·Allison Medical, Inc.·December 21, 2022

CardioTek EP-TRACER Software V2.x.

FDA Enforcement
Class II ·Completed·CardioTek BV·June 29, 2022

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

VariCam

FDA Enforcement
Class II ·Completed·GE Healthcare, LLC·January 16, 2019

Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves

FDA Enforcement
Class II ·Completed·Cardinal Health 200, LLC·April 20, 2022

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

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

CardioTek EP-TRACER Software V1.x and V2.0 The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user to monitor, display and record the signals. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.

FDA Enforcement
Class II ·Completed·CardioTek BV·July 12, 2017

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

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