7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HELENA FACTOR XII DEFICIENT
FDA 510(k)
FDA Class 2
·Hematology
LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Optimized Positioning System (OPS) Insight
FDA 510(k)
FDA Class 2
·Radiology
OT ULTRAMINI METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·October 16, 2012
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 2, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2010
Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025