7 results
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12ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX Expand), and 866424 (PIC iX Hardware) running Software Version Number 4.X
FDA Enforcement
Class II
·Ongoing·Philips North America·April 3, 2024
CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Upgrade), Software Version Number C.03.X
FDA Enforcement
Class II
·Ongoing·Philips North America·April 3, 2024
Patient Information Center iX and Patient Information Center iX Expand, Software Version 4.x.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·May 22, 2024
microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to accurately guide a microelectrode or instrument in the brain during stereotactic functional neurosurgical procedures.
FDA Enforcement
Class I
·Ongoing·FHC, Inc.·November 20, 2024
Patient Information Center iX; Software Version Number: 4.5.0
FDA Enforcement
Class II
·Ongoing·Philips North America·January 28, 2026
Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, Software Revision 4.0.1
FDA Enforcement
Class II
·Ongoing·Philips North America·October 16, 2024
Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210
FDA Enforcement
Class II
·Ongoing·FX SHOULDER·February 7, 2024