8 results
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6ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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MRIdian Linac Radiation Therapy System, Model 20000.
FDA Enforcement
Class II
·Terminated·Viewray, Inc.·May 8, 2019
Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in USA Dental Implants
FDA Enforcement
Class II
·Terminated·Implant Direct Sybron Manufacturing, LLC·November 20, 2019
Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.55 (NGA)/3.1.35(Jen II)
FDA Enforcement
Class II
·Terminated·Abaxis Inc·June 24, 2020
Vein Kit - No Introducer TVS4027-NI(A convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
STA UNICALIBRATOR (ref. 00675)
FDA Enforcement
Class II
·Terminated·Diagnostica Stago, Inc.·January 1, 2020
STA SYSTEM CONROL N + P (ref. 00678)
FDA Enforcement
Class II
·Terminated·Diagnostica Stago, Inc.·January 1, 2020
SpermMar Test 0.7ml Beads Particles Label on bottle: SpermMar Test IgA 0.7ml Beads/Particles-50 Tests IND REF SPMA_S LOT Expiration DO NOT FREEZE/NE PAS CONGELER FertiPro N.V. Label on box: SpermMar Test IGA 50 Determination Test Kit CONTENTS 1 vial SpermMar Latex Particles 0.7 ml REF SPMA_S FertiPro FertiPro N.V. Label on box: SpermMar Test IgA 50 Determination Test Kit Contents: 1 vial SpermMar latex particles, 0.7ml FertiPro N.V. For In Vitro Diagnostic Use SpermMar IqA Test Manufacturer's Product Number/Catalog Number: SPMA_S Lot/Serial Number Expiration Date FP14A09 02/29/2016 FP14A10 04/30/2016 FP14A11 04/30/2016 Product is a solution in filled into clear plastic bottles that is placed into a cardboard box. Both packages contain labeling information.
FDA Enforcement
Class II
·Terminated·Vitrolife Inc·April 22, 2015
NOA Medical Industries Behavioral Health Hospital bed side rails, Product number 1055050GRY-BOX
FDA Enforcement
Class II
·Ongoing·NOA Medical Industries Inc·January 22, 2025