1,067 results
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16ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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VITROS¿ Black Reference Slides CATALOG #: J02316 - Product Usage: The Black Reference Slide is a part/ tool used in the reflectometer correction factor adjustment procedure.
FDA Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics, INc.·May 5, 2021
Azurion
FDA Enforcement
Class II
·Ongoing·Philips Medical Systems Nederland B.V.·September 13, 2023
MultiDiagnost-Eleva
FDA Enforcement
Class II
·Ongoing·Philips Medical Systems Nederland B.V.·September 13, 2023
Allura Xper series
FDA Enforcement
Class II
·Ongoing·Philips Medical Systems Nederland B.V.·September 13, 2023
EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706
FDA Enforcement
Class II
·Ongoing·Encore Medical, LP·January 1, 2025
ACCU-CHEK AVIVA ASPAC STRIP 50CT- intended for Blood Glucose Monitoring System Catalog Number: 06453970020
FDA Enforcement
Class II
·Terminated·Roche Diabetes Care, Inc.·February 12, 2020
Accu-Chek Aviva Plus Retail Strips 50 ct - intended for Blood Glucose Monitoring System Catalog Number: 06908217001
FDA Enforcement
Class II
·Terminated·Roche Diabetes Care, Inc.·February 12, 2020
Accu-Chek Aviva Plus Health Network Strips- intended for Blood Glucose Monitoring System Catalog Number: 06908349001
FDA Enforcement
Class II
·Terminated·Roche Diabetes Care, Inc.·February 12, 2020
AquaLiner Hydrophilic Guidewire 0.035" X 180cm, Angle / Regular. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature.
FDA Enforcement
Class II
·Terminated·Nipro Medical Corporation·October 31, 2012
AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/ Regular. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature.
FDA Enforcement
Class II
·Terminated·Nipro Medical Corporation·October 31, 2012
AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Straight/ Regular. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature.
FDA Enforcement
Class II
·Terminated·Nipro Medical Corporation·October 31, 2012
Allura CV20 System Code: 722031
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 12, 2025
EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee Tibial Insert, 3R 14MM, VE, REF: 342-14-703
FDA Enforcement
Class II
·Ongoing·Encore Medical, LP·January 1, 2025
Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to be used to acquire, store, print, transfer, and archive clinical information.
FDA Enforcement
Class II
·Terminated·Merge Healthcare, Inc.·May 31, 2017
AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Straight/ Stiff. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature.
FDA Enforcement
Class II
·Terminated·Nipro Medical Corporation·October 31, 2012
AlluraXperFD20/10 System Code: (1) 722029
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 12, 2025
Allura Xper FD10C System Code: (1) 722001
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 12, 2025
Allura Xper FD20/20 System Code: (1) 722038
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 12, 2025
AlluraXperFD20/15 System Code: (1) 722058
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 12, 2025
AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/ Stiff. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature.
FDA Enforcement
Class II
·Terminated·Nipro Medical Corporation·October 31, 2012