17 results
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11ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Completed
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CarePoint 60 mL Syringe Without Needle, REF: 04-7560
FDA Enforcement
Class II
·Completed·Allison Medical, Inc.·December 21, 2022
CarePoint 60 mL Syringe Without Needle, REF: 04-7560
FDA Recall
Completed
·Allison Medical, Inc.·Product code FMF·September 3, 2020
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
Elekta Unity
FDA Recall
Completed
·Elekta Limited Linac House Fleming Way Crawley United Kingdom·Product code IYE·January 4, 2019
CardioTek EP-TRACER Software V2.x.
FDA Recall
Completed
·CardioTek BV Amerikalaan 70 Maastricht-Airport Netherlands·Product code DQK·April 25, 2022
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
MNA-420 ENC HDMI, Material Number K9303311; cathode ray tube display
FDA Recall
Completed
·Barco N.V. President Kennedypark 35 Kortrijk Belgium·Product code DXJ·April 24, 2024
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 Recall
Completed
·Luminex Corporation·Product code PEN·April 16, 2025
bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use Ventilator
FDA Recall
Completed
·Vyaire Medical·Product code CBK·May 5, 2023
bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ventilator
FDA Recall
Completed
·Vyaire Medical·Product code CBK·May 5, 2023