Calendar

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Week of Sep 29, 2025

Sep 29, 2025device 510k335d agoPaltop Advanced Dental Solutions, Ltd. — Paltop Dental Implant System (510k cleared)

Product code: DZE. Advisory committee: Dental. Type: Traditional

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Sep 29, 2025device 510k335d agoWilson-Cook Medical — SureTome SW Sphincterotome with DomeTip (510k cleared)

Product code: KNS. Advisory committee: Gastroenterology, Urology. Type: Traditional

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Sep 29, 2025device 510k335d agoGraphenano Dental S.L. — G-BLOCK (510k cleared)

Product code: EBF. Advisory committee: Dental. Type: Abbreviated

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Sep 29, 2025device 510k335d agoDisior, Ltd. — SMART PCFD (510k cleared)

Product code: QIH. Advisory committee: Radiology. Type: Traditional

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Sep 29, 2025device 510k335d agoHager& Meisinger GmbH — Master-Pin X (MP Pin with thread) (36BMP000030 / MP30) (510k cleared)

Product code: DZL. Advisory committee: Dental. Type: Traditional

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Sep 29, 2025device 510k335d agoTulavi Therapeutics, Inc. — allay Nerve Cap (TL5515-1); allay Nerve Cap (TL5515-2); Delivery Tips (TL-7627) (510k cleared)Turn Therapeutics Inc.

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

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Sep 29, 2025device pma335d agoLungpacer Medical USA, Inc. — AeroPace® System (PMA supplement)

Supplement type: Real-Time Process. Product code: SDL. Advisory committee: AN. Decision: APPR

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Sep 29, 2025device pma335d agoPhysio-Control, Inc. — LIFEPACK® CR2 Automated External Defibrillator (AED) (PMA supplement)

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

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Sep 29, 2025device pma335d agoEndotronix, Inc. — Cordella Pulmonary Artery Sensor System (CorPASS) (PMA supplement)

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

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Sep 29, 2025device pma335d agoZOLL Medical Corporation — ZOLL Zenix® Monitor/Defibrillator (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: MKJ. Advisory committee: CV. Decision: APPR

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Sep 29, 2025device pma335d agoHeartsine Technologies, Ltd. — HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) (PMA supplement)TAT TECHNOLOGIES LTD

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

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Sep 29, 2025device pma335d agoAbbott — CentriMag Circulatory Support System (PMA supplement)

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

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Sep 29, 2025device pma335d agoBard Peripheral Vascular, Inc. — LifeStream Balloon Expandable Vascular Covered Stent (PMA supplement)

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

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Sep 29, 2025device pma335d agoInspire Medical Systems — Model 2740 Inspire Programmer; Model 2740S/C SleepSync Programming System (PMA supplement)Inspire Medical Systems, Inc.

Supplement type: Real-Time Process. Product code: MNQ. Advisory committee: AN. Decision: APPR

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Sep 29, 2025device recall335d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system — Reason: Over time some systems may experience loss of imaging functionality and/or poor image quality due to potential corrosion of the Image Intensifier Television (IITV) control board. — Status: Ongoing

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Sep 29, 2025grant335d agoYALE UNIVERSITY — Optimizing Wolbachia-based interventions to ensure effective and equitable pr...

AI grant. $49,538. PI: Elisabeth Nelson

Week of Sep 29, 2025