Calendar

Week of Feb 16, 2026

Feb 19, 2026device 510k176d agoAcclarent, Inc. — Acclarent AERA Eustachian Tube Balloon Dilation System (510k cleared)

Product code: PNZ. Advisory committee: Ear, Nose, Throat. Type: Traditional

Feb 19, 2026device 510k176d agoCMT Health PTE., Ltd. — Profoject Low Dead Space Syringe /Profoject Tuberculin Syringe; Profoject Low Dead Space Syringe with Needle /Profoject Tuberculin Syringe with Needle; Profoject Low Dead Space Syringe with Permanent Needle /Profoject Tuberculin Syringe with Permanent Needle; Profoject Low Dead Space Safety Syringe /Profoject Tuberculin Safety Syringe (510k cleared)

Product code: QNQ. Advisory committee: General Hospital. Type: Traditional

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Feb 19, 2026device 510k176d agoAdaptiiv Medical Technologies, Inc. — TrueFit Bolus (510k cleared)Medical Care Technologies Inc.

Product code: MUJ. Advisory committee: Radiology. Type: Special

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Feb 19, 2026device 510k176d agoMedtronic, Inc. — Retrograde Coronary Sinus Perfusion Cannulae (510k cleared)Medtronic plc

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

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Feb 19, 2026device 510k176d agoCenterPoint Systems, LLC — AuST CSP Introducer (510k cleared)

Product code: DYB. Advisory committee: Cardiovascular. Type: Special

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Feb 19, 2026device pma176d agoABBOTT MEDICAL — Aveir VR Leadless Pacemaker, Aveir Leadless Pacemaker (Right Ventricular) (PMA supplement)

Supplement type: 135 Review Track For 30-Day Notice. Product code: PNJ. Advisory committee: CV. Decision: APPR

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Feb 19, 2026device pma176d agoAlcon Laboratories, LLC — Clareon TruPlus Aspheric Hydrophobic Acrylic Intraocular Lens (IOL); Clareon TruPlus Toric Aspheric Hydrophobic Acrylic (PMA supplement)Alcon Laboratories Inc

Supplement type: Real-Time Process. Product code: HQL. Advisory committee: OP. Decision: APPR

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Feb 19, 2026device pma176d agoABBOTT MEDICAL — Quartet; QuickFlex Micro (PMA supplement)

Supplement type: 135 Review Track For 30-Day Notice. Product code: NIK. Advisory committee: CV. Decision: APPR

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Feb 19, 2026device pma176d agoBolton Medical, Inc. — TREO® Abdominal Stent-Graft System (PMA supplement)

Supplement type: 30-Day Notice. Product code: MIH. Advisory committee: CV. Decision: OK30

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Feb 19, 2026device pma176d agoVeryan Medical, Ltd. — BioMimics 3D® Vascular Stent System (PMA supplement)

Supplement type: 30-Day Notice. Product code: NIP. Advisory committee: CV. Decision: OK30

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Feb 19, 2026device pma176d agoABBOTT MEDICAL — Durata, Optisure (PMA supplement)

Supplement type: 135 Review Track For 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: APPR

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Feb 19, 2026device pma176d agoMedtronic Neuromodulation — Master Restore, Itrel, Synerg, Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify, and Vec (PMA supplement)

Supplement type: Real-Time Process. Product code: LGW. Advisory committee: NE. Decision: APPR

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Feb 19, 2026device pma176d agoABBOTT MEDICAL — Tendril STS; OptiSense; UltiPace (PMA supplement)

Supplement type: 135 Review Track For 30-Day Notice. Product code: NVN. Advisory committee: CV. Decision: APPR

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Feb 19, 2026device pma176d agoBiomet Microfixation, Inc. — Total Temporomandibular Joint Replacement System (PMA supplement)

Supplement type: 30-Day Notice. Product code: LZD. Advisory committee: DE. Decision: OK30

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Feb 19, 2026device pma176d agoBolton Medical, Inc. — RelayPro Thoracic Stent-Graft System (PMA supplement)

Supplement type: 30-Day Notice. Product code: MIH. Advisory committee: CV. Decision: OK30

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Feb 19, 2026device pma176d agoABBOTT MEDICAL — IsoFlex (PMA supplement)

Supplement type: 135 Review Track For 30-Day Notice. Product code: NVN. Advisory committee: CV. Decision: APPR

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Feb 19, 2026device pma176d agoEdwards Lifesciences, LLC — SAPIEN M3 Transcatheter Mitral Valve Replacement System (PMA supplement)Edwards Lifesciences Corp

Supplement type: Normal 180 Day Track No User Fee. Product code: NPU. Advisory committee: CV. Decision: APPR

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Feb 19, 2026device recall176d agoAMO Puerto Rico Manufacturing, Inc. device recall (Cls II)

Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Model/Catalog Number: DIB00 Software Version: N/A Product Description: The TECNIS SIMPLICITY" Delivery System is designed to provide a sterile,controlled and touch-free method of delivering the lens into the eye. The lens is preloaded and pre-assembled in the delivery system. The TECNIS SIMPLICITY" Delivery System Model DIB00 contains the TECNISEyhance" IOL, which is a one-piece, foldable, posterior chamber lens with an overall diameter of 13.0 mm and an optic diameter of 6.0 mm. The TECNIS SIMPLICITY" Delivery System is designed to provide a sterile,controlled and touch-free method of delivering the lens into the eye. Component: No — Reason: Due to identifying a limited quantity of intraocular lenses that may have a haptic that sticks to the optic which prevents the lens from unfolding as consistently as expected. — Status: Ongoing

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Feb 19, 2026grant176d agoSTANFORD UNIVERSITY — Salmonella persistence in Mesenteric Lymph NodesStanford University

AI grant. $771,210. PI: Denise M Monack

Week of Feb 16, 2026