Calendar

Week of Mar 9, 2026

Mar 13, 2026device 510k156d agoBoston Scientific Corporation — TheraSphere 360 Y-90 Management Platform (510k cleared)BOSTON SCIENTIFIC CORP

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

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Mar 13, 2026device 510k156d agoZeto, Inc. — New Wave System (510k cleared)

Product code: GWQ. Advisory committee: Neurology. Type: Special

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Mar 13, 2026device 510k156d agoTaewoong Medical Co., Ltd. — Niti-S SPAXUS Stent (510k cleared)

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

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Mar 13, 2026device 510k156d agoPressure Products Medical Device Manufacturing, LLC — SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R) (510k cleared)

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

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Mar 13, 2026device 510k156d agoSolventum Germany GmbH — Promogran Prisma Collagen Matrix with ORC and Silver (510k cleared)

Product code: FRO. Advisory committee: Unknown. Type: Traditional

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Mar 13, 2026device 510k156d agoGenbody.Inc. — GenBody COVID-19 Ag Home Test (510k cleared)

Product code: QYT. Advisory committee: Microbiology. Type: Traditional

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Mar 13, 2026device pma156d agoExact Sciences Corporation — Cologuard® (PMA supplement)

Supplement type: 30-Day Notice. Product code: PHP. Advisory committee: PA. Decision: OK30

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Mar 13, 2026device pma156d agoInspire Medical Systems — Model 3150 Implantable Pulse Generator (IPG) (PMA supplement)Inspire Medical Systems, Inc.

Supplement type: 30-Day Notice. Product code: MNQ. Advisory committee: AN. Decision: OK30

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Mar 13, 2026device pma156d agoExact Sciences Corporation — Cologuard Plus (PMA supplement)

Supplement type: 30-Day Notice. Product code: PHP. Advisory committee: PA. Decision: OK30

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Mar 13, 2026device pma156d agoBeyond Air, Inc. — LungFit PH (PMA supplement)Beyond Air, Inc.

Supplement type: 30-Day Notice. Product code: QTB. Advisory committee: AN. Decision: OK30

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Mar 13, 2026device pma156d agoABBOTT MEDICAL — Proclaim Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (PMA supplement)

Supplement type: 30-Day Notice. Product code: LGW. Advisory committee: NE. Decision: OK30

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Mar 13, 2026device pma156d agoABBOTT MEDICAL — Proclaim Doral Root Ganglion (DRG) IPG (PMA supplement)GALT Pharmaceuticals LLC

Supplement type: 30-Day Notice. Product code: PMP. Advisory committee: NE. Decision: OK30

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Mar 13, 2026device pma156d agoCarbon Medical Technologies, Inc. — Durasphere Injectable Bulking Agent (PMA supplement)Medical Care Technologies Inc.

Supplement type: Normal 180 Day Track. Product code: LNM. Advisory committee: GU. Decision: APPR

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Mar 13, 2026device pma156d agoVantive US Healthcare, LLC — Prismaflex TPE2000 Set (PMA supplement)

Supplement type: Real-Time Process. Product code: MDP. Advisory committee: GU. Decision: APPR

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Mar 13, 2026device pma156d agoABBOTT MEDICAL — Infinity Deep Brain Stimulation (DBS) IPG (PMA supplement)

Supplement type: 30-Day Notice. Product code: MHY. Advisory committee: NE. Decision: OK30

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Mar 13, 2026grant156d agoMASSACHUSETTS GENERAL HOSPITAL — Electronic Partner Notification for STIs: A Syndemic Approach to Improve HIV ...Massachusetts General Hospital

MH grant. $855,983. PI: Kevin Ard

Week of Mar 9, 2026