Calendar

Week of Apr 6, 2026

Apr 9, 2026device 510k125d agoShanghai Apolo Medical Technology Co., Ltd. — Picosecond Nd:YAG Laser Systems (Model: HS-298) (510k cleared)NewBay Medical Technology Co Ltd

Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional

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Apr 9, 2026device 510k125d agoAnhui Happiness Workshop Instruments Co., Ltd. — Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200) (510k cleared)

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

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Apr 9, 2026device 510k125d agoShandong Huge Dental Material Corporation — Eternal Art Porcelain Powders (510k cleared)

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

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Apr 9, 2026device 510k125d agoRivanna Medical, Inc. — Accuro XV (510k cleared)Vivani Medical, Inc.

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

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Apr 9, 2026device pma125d agoSynergy Spine Solutions, Inc. — Synergy Disc (PMA supplement)

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

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Apr 9, 2026device pma125d agoAsahi Kasei Medical Co., Ltd. — Plasmaflo OP-05 W(A) (PMA supplement)

Supplement type: 30-Day Notice. Product code: MDP. Advisory committee: GU. Decision: OK30

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Apr 9, 2026device pma125d agoW. L. Gore & Associates, Inc. — GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE) (PMA supplement)

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

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Apr 9, 2026device pma125d agoMedtronic, Inc. — Avalus Bioprosthesis (PMA supplement)Medtronic plc

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

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Apr 9, 2026device pma125d agoEv3 Neurovascular — Apollo Onyx Delivery Micro Catheter (PMA supplement)

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

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Apr 9, 2026device pma125d agoAdvanced Bionics — HiResolution Bionic Ear System Ultra and Ultra 3D Thin PCB (PMA supplement)

Supplement type: 30-Day Notice. Product code: MCM. Advisory committee: EN. Decision: OK30

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Apr 9, 2026device pma125d agoNovocure, GmbH — Optune HFE Transducer Array Soft Part Components (PMA supplement)NovoCure Ltd

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

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Apr 9, 2026device pma125d agoCooperVision, Inc. — Biofinity Sphere, Biofinity XR Sphere, Biofinity Energys, Biofinity Toric, Biofinity XR Toric, Biofinity Multifocal; Bio (PMA supplement)

Supplement type: 30-Day Notice. Product code: LPM. Advisory committee: OP. Decision: OK30

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Apr 9, 2026device pma125d agoSeikagaku Corp. — GEL-ONE (PMA supplement)Seikagaku Corp

Supplement type: 30-Day Notice. Product code: MOZ. Advisory committee: OR. Decision: OK30

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Apr 9, 2026device pma125d agoMedtronic, Inc. — Melody Transcatheter Pulmonary Valve (PMA supplement)Medtronic plc

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

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Apr 9, 2026device pma125d agoEdwards Lifesciences, LLC — SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES (PMA supplement)Edwards Lifesciences Corp

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

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Apr 9, 2026device pma125d agoEdwards Lifesciences, LLC — Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System (PMA supplement)Edwards Lifesciences Corp

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

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Apr 9, 2026device pma125d agoBoston Scientific Corp — Rotablator; ROTAPRO Rotational Atherectomy Systems (PMA supplement)BOSTON SCIENTIFIC CORP

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

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Apr 9, 2026device pma125d agoABBOTT MEDICAL — FlexAbility Ablation Catheter (Flex) and FlexAbility Ablation Catheter, Sensor Enabled (Flex SE) (PMA supplement)

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

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Apr 9, 2026grant125d agoEASTERN WASHINGTON UNIVERSITY — Unraveling the Biosynthesis of Aromatic Virulence Factors in Pseudomonas aeru...

AI grant. $470,978. PI: Benjamin Robert Lundgren

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Apr 9, 2026grant125d agoUNIVERSITY OF HAWAII AT MANOA — New approach methodologies using stem cell morphogenesis models for preclinic...

ES grant. $156,500. PI: YUSUKE MARIKAWA

full page →nih reporter ↗

Apr 9, 2026grant125d agoUNIVERSITY OF WASHINGTON — Mentoring Patient-Oriented Research to Improve Syphilis Screening and Treatme...University of Washington

NR grant. $175,280. PI: Jillian Pintye

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Apr 9, 2026grant125d agoUNIVERSITY OF CHICAGO — A Sicangu-driven social network strategy for syphilis prevention

AI grant. $417,567. PI: John Schneider

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Apr 9, 2026grant125d agoUNIVERSITY OF MINNESOTA — Development of broadly protective Lassa vaccines using the Pichinde virus vectorUniversity of Minnesota

AI grant. $192,500. PI: YUYING LIANG

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Apr 9, 2026grant125d agoUNIVERSITY OF MINNESOTA — Targeting oncogenic KRAS to sensitize pancreatic cancer to NK cell immunotherapyUniversity of Minnesota

CA grant. $47,827. PI: Paarth Bhupendra Dodhiawala

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Apr 9, 2026grant125d agoTHE TRUSTEES OF THE STEVENS INSTITUTE OF TECHNOLOGY — Music-based biofeedback to improve balance control in adults with Parkinson's...

AT grant. $676,491. PI: Antonia Zaferiou

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Apr 9, 2026grant125d agoUNIVERSITY OF ROCHESTER — Brain-immune crosstalk via circadian regulation of glymphatic and lymphatic f...University of Rochester

AT grant. $550,030. PI: Lauren M Hablitz

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Apr 9, 2026grant125d agoBRIGHAM AND WOMEN'S HOSPITAL — Lipidomic discovery of physiological CD1 antigens and blockers for human T cellsBrigham and Women's Hospital

AI grant. $893,459. PI: DAVID Branch MOODY

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Apr 9, 2026grant125d agoBIOLA UNIVERSITY, INC. — BRIDGE: Building Religious Insights for Developing Genomic Engagement

HG grant. $705,019. PI: Eu Gene Chin

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Apr 9, 2026grant125d agoYALE UNIVERSITY — Understanding carnitine reprogramming in sepsis

AI grant. $194,904. PI: Eric Isaac Elliott

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Apr 9, 2026grant125d agoEMORY UNIVERSITY — Novel Long-Acting HBV Capsid Assembly ModulatorsEmory University

AI grant. $954,603. PI: Raymond Felix Schinazi

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Apr 9, 2026grant125d agoUNIVERSITY OF WASHINGTON — The upper intestinal environment and mediators of human cholera severityUniversity of Washington

AI grant. $183,439. PI: Ana A Weil

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Apr 9, 2026grant125d agoUNIVERSITY OF SOUTHERN CALIFORNIA — Prenatal and Parenting Influences on School-Age Executive Function: Separate ...University of Southern California

HD grant. $77,902. PI: Gabrielle Rose Rinne

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04/10/2026recall124d agoVital Nutrient recall: Dietary Supplements

Aller-C Dietary Supplement

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Apr 10, 2026approval124d agoCONCERTA (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalJanssen Therapeutics

Sponsor: JANSSEN PHARMS. Form: TABLET, EXTENDED RELEASE. Route: ORAL

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Apr 10, 2026approval124d agoLOSARTAN POTASSIUM — FDA approvalLOSARTAN POTASSIUM

Sponsor: MICRO LABS. Form: TABLET. Route: ORAL

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Apr 10, 2026approval124d agoMETHYLPREDNISOLONE — FDA approvalPFIZER INC

Sponsor: TIANJIN TIANYAO. Form: TABLET. Route: ORAL

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