112 results
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18ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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25-LHP-928, HeNe Laser System, 25 mW
FDA Enforcement
Class II
·Ongoing·PACIFIC LASERTECH, LLC·September 18, 2024
25-LHP-828, HeNe Laser System, 35 mW
FDA Enforcement
Class II
·Ongoing·PACIFIC LASERTECH, LLC·September 18, 2024
N-LHP-928, HeNe Laser System, 35 mW
FDA Enforcement
Class II
·Ongoing·PACIFIC LASERTECH, LLC·September 18, 2024
NaviNetics Skull Anchor Key and Drill Kit, REF NN1215
FDA Enforcement
Class II
·Ongoing·Navinetics Inc·April 10, 2024
Newport s N-LHP-928(j) units if sold as a laser head/power supply set, and N5-LPL-944-080 and N6-LPL-944-080 if sold as a power supply alone.
FDA Enforcement
Class II
·Ongoing·Newport Corp·June 12, 2024
ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery.
FDA Enforcement
Class II
·Completed·Aesculap Implant Systems LLC·July 27, 2022
2D Perfusion, release R1.0.x, R1.1.x, R1.2, and R1.2.1
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 26, 2023
AVANOS MIC-KEY SF Gastrostomy Feeding Tube
FDA Enforcement
Class II
·Terminated·Avanos Medical, Inc.·September 23, 2020
ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
FDA Enforcement
Class II
·Terminated·Aesculap Implant Systems LLC·July 27, 2022
Fresenius 2008T Series Hemodialysis System
FDA Enforcement
Class II
·Terminated·Fresenius Medical Care Renal Therapies Group, LLC·January 25, 2017
Fresenius 2008K Series : Hemodialysis System
FDA Enforcement
Class II
·Terminated·Fresenius Medical Care Renal Therapies Group, LLC·January 25, 2017
Fresenius 2008K2 Series : Hemodialysis System
FDA Enforcement
Class II
·Terminated·Fresenius Medical Care Renal Therapies Group, LLC·January 25, 2017
Fresenius 2008K@home Series : Hemodialysis System
FDA Enforcement
Class II
·Terminated·Fresenius Medical Care Renal Therapies Group, LLC·January 25, 2017
SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 26, 2023
Graseby 3300 Pump and Graseby 3000 Series Pump Accessories Patient controlled syringe pump. Use for Infusion
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·February 7, 2018
The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE) family of digital x-ray detectors coupled.
FDA Enforcement
Class II
·Ongoing·FUJIFILM Healthcare Americas Corporation·October 2, 2024
BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad; and Pump Module Door Assembly Replacement Kit with Pump Module Keypad, Parts: 49000239; 49000346; 49000438; 49000439.
FDA Enforcement
Class I
·Ongoing·CareFusion 303, Inc.·April 7, 2021
Philips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·June 10, 2026
Philips Azurion 5M12, Model Numbers: 722227 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·June 10, 2026
Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·June 10, 2026