38 results
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7ms
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Sources: EU EUDAMED, US FDA
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
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
Myosa for Kids KS1 REF MyOSAKS1_Sb/Sp/Mb/Mp/Lb/Lc KS2 REF MyOSAKS2_Sb/Sc/Mb/Mc/Mp/Lb/Lc Myosa for Kids is a mouthguard in 3 different sizes (sm, med, lg) that can be used in children ages 3-15 to address breathing and myofunctional disorders. Catalog Numbers:
FDA Enforcement
Class II
·Ongoing·Myofunctional Research Company USA·December 24, 2025
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
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
Medline Convenience Kits: 1) DRAPE PACK, Model Number: DYNJ35363A; 2) SICK KIDS-GENERAL CUSTOM SPLIT, Model Number: SPTPCD10005
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·February 25, 2026
Medline Convenience Kits: 1) DRAPE PACK, Model Number: DYNJ35363A; 2) SICK KIDS-GENERAL CUSTOM SPLIT, Model Number: SPTPCD10005
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·May 13, 2026
medex TranStar KIDS KIT 31IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9544
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·October 30, 2024
medex TranStar KIDS KIT 34IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9545
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·October 30, 2024
medex TranStar KIDS KIT 10IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9548
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·October 30, 2024
medex TranStar KIDS KIT 19IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9543
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·October 30, 2024
medex TranStar KIDS KIT 7INCH CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9547
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·October 30, 2024
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
Philips Azurion 7M20, Model Numbers: 722079, 722224 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