13 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103, UC-104)
FDA 510(k)
FDA Class 2
·Cardiovascular
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690129905·PS-C Insert, Size 2 x 13mm
Steerable IBD
FDA UDI
Seaspine Orthopedics Corporation·10889981117351·Fixed Rasp; 22x13 (05-3303)
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B167310222213110·
ENI-EYE SH SPHERE (EFROFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
FDA 510(k)
FDA Class 2
·Ophthalmic
syngo.CT Neuro Perfusion
FDA 510(k)
FDA Class 2
·Radiology
Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Software Version Number - All versions: R1.X, R2.X, R3.X
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 18, 2026
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·November 3, 2014
RELIANCE 444 WASHER
FDA Adverse Event
STERIS CANADA CORPORATION·Product code LDS·August 24, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 12, 2013
Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis·Product code OWB·March 3, 2026
Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Software Version Number - All versions: R1.X, R2.X, R3.X
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·January 26, 2026