Calendar

Week of Mar 23, 2026

Mar 25, 2026device 510k147d agoSpinepoint, LLC — Flex-Z Cervical Cage (510k cleared)

Product code: ODP. Advisory committee: Orthopedic. Type: Traditional

Mar 25, 2026device 510k147d agoMevion Medical Systems, Inc. — S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) (510k cleared)MERIT MEDICAL SYSTEMS INC

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

full page →fda device 510k ↗

Mar 25, 2026device 510k147d agoBausch and Lomb, Incorporated — Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E) (510k cleared)

Product code: HQC. Advisory committee: Ophthalmic. Type: Traditional

full page →fda device 510k ↗

Mar 25, 2026device pma147d agoLenstec, Inc. — ClearView 3 IOL (PMA supplement)

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

full page →fda device pma ↗

Mar 25, 2026device pma147d agoABBOTT MEDICAL — CardioMEMS HF System (PMA supplement)

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

full page →fda device pma ↗

Mar 25, 2026device pma147d agoBoston Scientific Corp — WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY (PMA supplement)BOSTON SCIENTIFIC CORP

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

full page →fda device pma ↗

Mar 25, 2026device pma147d agoABBOTT MEDICAL — HeartMate 3 Left Ventricular Assist System (PMA supplement)

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

full page →fda device pma ↗

Mar 25, 2026device pma147d agoMedtronic Vascular — Onyx Frontier Zotarolimus Eluting Coronary Stent System (PMA supplement)

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

full page →fda device pma ↗

Mar 25, 2026device pma147d agoMedtronic, Inc. — Symplicity Spyral Renal Denervation Catheter (PMA supplement)Medtronic plc

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

full page →fda device pma ↗

Mar 25, 2026device pma147d agoCook Ireland, Ltd. — Zilver® PTX® Drug-Eluting Peripheral Stent (PMA supplement)

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

full page →fda device pma ↗

Mar 25, 2026grant147d agoMASSACHUSETTS GENERAL HOSPITAL — Characterizing intracortical feedforward and feedback sensory processes in ASDMassachusetts General Hospital

MH grant. $824,728. PI: Jyrki Ahveninen

full page →nih reporter ↗

Mar 25, 2026grant147d agoUNIVERSITY OF TEXAS HLTH SCIENCE CENTER — Development of first-in-class AAK1 PROTACs for ovarian cancer

CA grant. $593,338. PI: Lingtao Jin

full page →nih reporter ↗

Mar 25, 2026grant147d agoSTANFORD UNIVERSITY — Advancing Personalized Cardiac Organoids - Converging In Vitro, In Chemico, a...Stanford University

TR grant. $3,091,157. PI: Afshin Beheshti

full page →nih reporter ↗

Mar 25, 2026grant147d agoMASSACHUSETTS INSTITUTE OF TECHNOLOGY — A Platform for Arene Activation via Machine Learning and Small Molecule Catal...

GM grant. $74,632. PI: Andria Pace

full page →nih reporter ↗

Mar 25, 2026grant147d agoMEDICAL UNIVERSITY OF SOUTH CAROLINA — RESP-FIT: A Respiratory Muscle Strength Training Intervention for COPD

NR grant. $1,778,418. PI: Sarah N. Miller

full page →nih reporter ↗

Mar 25, 2026grant147d agoWASHINGTON UNIVERSITY — Neural Circuits in Preoptic Hypothalamus Regulating Energy Expenditure and Me...

DK grant. $720,353. PI: Aaron J Norris

full page →nih reporter ↗

Mar 25, 2026grant147d agoJOHNS HOPKINS UNIVERSITY — Adapting and testing an evidence based digitally delivered healthy relationsh...Johns Hopkins University

NR grant. $1,804,481. PI: Teresa Brockie

full page →nih reporter ↗

Mar 25, 2026grant147d agoICAHN SCHOOL OF MEDICINE AT MOUNT SINAI — Ghrelin receptor and striosomal interactions in stress-induced decision-makingDutch Heart Foundation

MH grant. $827,879. PI: Alexander Friedman

full page →nih reporter ↗

Mar 26, 2026approval146d agoCLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER (CLINDAMYCIN PHOSPHATE) — FDA approvalCLEOCIN

Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

full page →CLEOCIN →fda approvals ↗

Mar 26, 2026approval146d agoBKEMV (ECULIZUMAB-AEEB) — FDA approvaleculizumab biosimilar

Sponsor: AMGEN INC. Form: INJECTABLE. Route: INJECTION

full page →eculizumab biosimilar →fda approvals ↗

Mar 26, 2026approval146d agoCLEOCIN HYDROCHLORIDE (CLINDAMYCIN HYDROCHLORIDE) — FDA approvalclindamycin hydrochloride

Sponsor: PFIZER. Form: CAPSULE. Route: ORAL

full page →clindamycin hydrochloride →fda approvals ↗

Mar 26, 2026approval146d agoNOREPINEPHRINE BITARTRATE IN 5% DEXTROSE (NOREPINEPHRINE BITARTRATE) — FDA approvalNOREPINEPHRINE BITARTRATE

Sponsor: SAGENT. Form: SOLUTION. Route: INTRAVENOUS

full page →NOREPINEPHRINE BITARTRATE →fda approvals ↗

Mar 26, 2026approval146d agoMEKINIST (TRAMETINIB) — FDA approvalSpexotras

Sponsor: NOVARTIS. Form: SOLUTION. Route: ORAL

full page →Spexotras →fda approvals ↗

Mar 26, 2026approval146d agoTAFINLAR (DABRAFENIB MESYLATE) — FDA approvaldabrafenib mesylate ODT

Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL

full page →dabrafenib mesylate ODT →fda approvals ↗

Mar 26, 2026approval146d agoMEKINIST (TRAMETINIB DIMETHYL SULFOXIDE) — FDA approvalSpexotras

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →Spexotras →fda approvals ↗

Mar 26, 2026approval146d agoCLEOCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE) — FDA approvalCLEOCIN

Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

full page →CLEOCIN →fda approvals ↗

Mar 26, 2026approval146d agoKADCYLA (ADO-TRASTUZUMAB EMTANSINE) — FDA approvaltrastuzumab emtansine

Sponsor: GENENTECH. Form: VIAL. Route: SINGLE-USE

full page →trastuzumab emtansine →fda approvals ↗

Mar 26, 2026approval146d agoAWIQLI FLEXTOUCH (INSULIN ICODEC) — FDA approvalinsulin icodec

Sponsor: NOVO NORDISK INC. Form: INJECTION. Route: SOLUTION

full page →insulin icodec →fda approvals ↗

Mar 26, 2026approval146d agoLABETALOL HYDROCHLORIDE — FDA approvalLABETALOL HYDROCHLORIDE

Sponsor: HERITAGE PHARMA. Form: TABLET. Route: ORAL

full page →LABETALOL HYDROCHLORIDE →fda approvals ↗

Mar 26, 2026approval146d agoDOXYCYCLINE HYCLATE — FDA approvalDOXYCYCLINE HYCLATE

Sponsor: ALEMBIC. Form: TABLET, DELAYED RELEASE. Route: ORAL

full page →DOXYCYCLINE HYCLATE →fda approvals ↗

Mar 26, 2026approval146d agoDOXYCYCLINE HYCLATE — FDA approvalDOXYCYCLINE HYCLATE

Sponsor: ALEMBIC. Form: TABLET, DELAYED RELEASE. Route: ORAL

full page →DOXYCYCLINE HYCLATE →fda approvals ↗

Mar 26, 2026approval146d agoPAROXETINE HYDROCHLORIDE — FDA approvalPAROXETINE HYDROCHLORIDE

Sponsor: ALEMBIC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →PAROXETINE HYDROCHLORIDE →fda approvals ↗

Mar 26, 2026approval146d agoNEFFY (EPINEPHRINE) — FDA approvalInternational Medication Systems Ltd

Sponsor: ARS PHARMS OPERATION. Form: SPRAY. Route: NASAL

full page →fda approvals ↗

Mar 26, 2026approval146d agoNEFFY (EPINEPHRINE) — FDA approvalInternational Medication Systems Ltd

Sponsor: ARS PHARMS OPERATION. Form: SPRAY. Route: NASAL

full page →fda approvals ↗

Mar 26, 2026approval146d agoTAFINLAR (DABRAFENIB MESYLATE) — FDA approvaldabrafenib mesylate ODT

Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL

full page →dabrafenib mesylate ODT →fda approvals ↗

Mar 26, 2026device 510k146d agoLunit, Inc. — Lunit INSIGHT DBT (V1.2) (510k cleared)

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

full page →fda device 510k ↗

Mar 26, 2026device 510k146d agoMedtronic Navigation, Inc. — Stealth AXiS Cranial clinical application (510k cleared)

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

full page →fda device 510k ↗

Mar 26, 2026device 510k146d agoVizaramed, Inc. — Multiflex Steerable Sheath 17.5F (510k cleared)

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

full page →fda device 510k ↗

Mar 26, 2026device 510k146d agoSurgify Medical OY — Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo (54.125.NVG.U1); Surgify Halo (54.000.SEE.U1); Surgify Halo (40.070.NVG.U1); Surgify Halo (40.125.NVG.U1); Surgify Halo (40.000.SEE.U1); Surgify Halo (30.070.NVG.U2); Surgify Halo (30.125.NVG.U2); Surgify Halo (30.000.SEE.U2) (510k cleared)

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

full page →fda device 510k ↗

Mar 26, 2026device 510k146d agoBIOMERIEUX — VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) (510k cleared)

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

full page →fda device 510k ↗

Mar 26, 2026device 510k146d agoBlue Belt Technologies, Inc. — REAL INTELLIGENCE CORI (510k cleared)BETA Technologies, Inc.

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

full page →fda device 510k ↗

Mar 26, 2026device 510k146d agoDevilbiss Healthcare, LLC — DeVilbiss 5 Liter Oxygen Concentrator (555) (510k cleared)

Product code: CAW. Advisory committee: Anesthesiology. Type: Traditional

full page →fda device 510k ↗

Mar 26, 2026device 510k146d agoShenzhen Urion Technology Co., Ltd. — Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

full page →fda device 510k ↗

Mar 26, 2026device 510k146d agoAirs Medical, Inc. — SwiftMR (510k cleared)AVITA Medical, Inc.

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

full page →fda device 510k ↗

Mar 26, 2026device 510k146d agoRestore Robotics — Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184) (510k cleared)

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

full page →fda device 510k ↗

Mar 26, 2026device pma146d agoMedinol, Ltd. — EluNIR Ridaforolimus Eluting Coronary Stent System (PMA supplement)IGC Pharma, Inc.

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

full page →fda device pma ↗

Mar 26, 2026device pma146d agoMedtronic Neuromodulation — Altaviva (PMA supplement)

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

full page →fda device pma ↗

Mar 26, 2026device pma146d agoBolton Medical, Inc. — TREO® Abdominal Stent-Graft System (PMA supplement)

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

full page →fda device pma ↗

Mar 26, 2026grant146d agoMEDICAL UNIVERSITY OF SOUTH CAROLINA — Data Analytics Training And Professional Development (DATA-Pro) for Behaviora...

CA grant. $215,976. PI: Kalyani Sonawane

full page →nih reporter ↗

Mar 26, 2026grant146d agoUNIVERSITY OF CALIFORNIA, SAN DIEGO — The Impact of Bile Salt Hydrolase on Intestinal T Cells in ColitisUniversity of California San Diego

DK grant. $43,313. PI: Elizabeth A Brown

full page →nih reporter ↗

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Week of Mar 23, 2026