Calendar

Week of Nov 10, 2025

Nov 10, 2025device 510k281d agoKLS-Martin L.P. — KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE (510k cleared)

Product code: GXN. Advisory committee: Neurology. Type: Traditional

full page →fda device 510k ↗

Nov 10, 2025device 510k281d agoQpix Solutions, Inc. — EzSensor HD, EzSensor UHD (510k cleared)UL Solutions Inc.

Product code: MUH. Advisory committee: Dental. Type: Special

full page →fda device 510k ↗

Nov 10, 2025device 510k281d agoPhilips Medizin Systeme Böblingen GmbH — IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot Module Rack FMX-4 (866471 866470 866468 ) (510k cleared)

Product code: MHX. Advisory committee: Cardiovascular. Type: Traditional

full page →fda device 510k ↗

Nov 10, 2025device 510k281d agoWithings — Withings BeamO (SCT02) (510k cleared)

Product code: DPS. Advisory committee: Cardiovascular. Type: Traditional

full page →fda device 510k ↗

Nov 10, 2025device pma281d agoMedtronic, Inc. — Hancock II Bioprosthesis (PMA supplement)Medtronic plc

Supplement type: Real-Time Process. Product code: DYE. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗

Nov 10, 2025device pma281d agoABBOTT MEDICAL — CardioMEMS HF System (Merlin.net PCN HF Portal (Model MN6000) and CardioMEMS Backend Web Application (Model CM4000)) (PMA supplement)

Supplement type: Real-Time Process. Product code: MOM. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗

Nov 10, 2025device pma281d agoMedtronic, Inc. — Freestyle Bioprosthesis (PMA supplement)Medtronic plc

Supplement type: Real-Time Process. Product code: LWR. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗

Nov 10, 2025device pma281d agoMedtronic, Inc. — Mosaic Bioprosthesis (PMA supplement)Medtronic plc

Supplement type: Real-Time Process. Product code: DYE. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗

Nov 10, 2025device pma281d agoMedtronic, Inc. — Avalus Bioprosthesis, Avalus Ultra Bioprosthesis (PMA supplement)Medtronic plc

Supplement type: Real-Time Process. Product code: LWR. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗

Nov 10, 2025device recall281d agoBeckman Coulter, Inc. device recall (Cls II)

COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells on all UniCel DxH Coulter Cellular Analysis Systems. For use as a rinsing agent on the UniCel DxH Slidemaker Stainers. For use as a diluent in conjunction with DxH ECO Cell Lyse for counting and sizing blood cells. For use as a rinsing agent. — Reason: Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers. — Status: Ongoing

Week of Nov 10, 2025