Calendar

Week of Mar 23, 2026

Mar 25, 2026device 510k146d agoNvision Biomedical Technologies, Inc. — Vortex5 Tailor's Bunion Correction System (510k cleared)

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

full page →fda device 510k ↗

Mar 25, 2026device 510k146d agoArthroCare Corporation — LYNX COBLATION Laryngeal Wand (72290254) (510k cleared)

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

full page →fda device 510k ↗

Mar 25, 2026device 510k146d agoLetus Corporation — MiraChlor Antimicrobial Wound Solution (510k cleared)

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

full page →fda device 510k ↗

Mar 25, 2026device 510k146d agoAlphatec Spine, Inc. — Invictus Bands System (510k cleared)

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

full page →fda device 510k ↗

Mar 25, 2026device 510k146d agoMedline Industries, LP — Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78 Infant Circuit, HUD99060KIT / Dri-Tech with 78 Infant Circuit Kit, HUD99001KIT / Single Limb Infant Circuit Dri-Tech Kit, HUD99009KIT / Dri-Tech with 60 Infant Circuit Kit, HUD99018KIT / Dri-Tech with 44 Infant Circuit Kit, HUD870NKIT / Dri-Tech Infant Accessory Bag, HUD1631 / Infant Wye Connector with Swivel) (510k cleared)

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

full page →fda device 510k ↗

Mar 25, 2026device 510k146d agoNovastep SAS — Airlock® Ankle Plating System (510k cleared)

Product code: HRS. Advisory committee: Orthopedic. Type: Abbreviated

full page →fda device 510k ↗

Mar 25, 2026device 510k146d agoZhuhai Wesee Meditech Co., Ltd. — Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B) (510k cleared)

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

full page →fda device 510k ↗

Mar 25, 2026device 510k146d agoSandstone Medical (Suzhou), Inc. — Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle (510k cleared)

Product code: FMI. Advisory committee: General Hospital. Type: Special

full page →fda device 510k ↗

Mar 25, 2026device 510k146d agoCurexo, Inc. — CUVIS-joint (CJ150) (510k cleared)Curevo Inc

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

full page →fda device 510k ↗

Mar 25, 2026device 510k146d agoSpinepoint, LLC — Flex-Z Cervical Cage (510k cleared)

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

full page →fda device 510k ↗

Mar 25, 2026device 510k146d 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 510k146d 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 pma146d 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 pma146d 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 pma146d 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 pma146d 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 pma146d 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 pma146d 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 pma146d 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, 2026grant146d 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, 2026grant146d 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, 2026grant146d 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, 2026grant146d 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, 2026grant146d 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, 2026grant146d 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, 2026grant146d 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, 2026grant146d 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, 2026approval145d 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, 2026approval145d agoBKEMV (ECULIZUMAB-AEEB) — FDA approvaleculizumab biosimilar

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

full page →eculizumab biosimilar →fda approvals ↗

Mar 26, 2026approval145d agoCLEOCIN HYDROCHLORIDE (CLINDAMYCIN HYDROCHLORIDE) — FDA approvalclindamycin hydrochloride

Sponsor: PFIZER. Form: CAPSULE. Route: ORAL

full page →clindamycin hydrochloride →fda approvals ↗

Mar 26, 2026approval145d agoNOREPINEPHRINE BITARTRATE IN 5% DEXTROSE (NOREPINEPHRINE BITARTRATE) — FDA approvalNOREPINEPHRINE BITARTRATE

Sponsor: SAGENT. Form: SOLUTION. Route: INTRAVENOUS

full page →NOREPINEPHRINE BITARTRATE →fda approvals ↗

Mar 26, 2026approval145d agoMEKINIST (TRAMETINIB) — FDA approvalSpexotras

Sponsor: NOVARTIS. Form: SOLUTION. Route: ORAL

full page →Spexotras →fda approvals ↗

Mar 26, 2026approval145d agoTAFINLAR (DABRAFENIB MESYLATE) — FDA approvaldabrafenib mesylate ODT

Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL

full page →dabrafenib mesylate ODT →fda approvals ↗

Mar 26, 2026approval145d agoMEKINIST (TRAMETINIB DIMETHYL SULFOXIDE) — FDA approvalSpexotras

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →Spexotras →fda approvals ↗

Mar 26, 2026approval145d agoCLEOCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE) — FDA approvalCLEOCIN

Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

full page →CLEOCIN →fda approvals ↗

Mar 26, 2026approval145d agoKADCYLA (ADO-TRASTUZUMAB EMTANSINE) — FDA approvaltrastuzumab emtansine

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

full page →trastuzumab emtansine →fda approvals ↗

Mar 26, 2026approval145d agoAWIQLI FLEXTOUCH (INSULIN ICODEC) — FDA approvalinsulin icodec

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

full page →insulin icodec →fda approvals ↗

Mar 26, 2026approval145d agoLABETALOL HYDROCHLORIDE — FDA approvalLABETALOL HYDROCHLORIDE

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

full page →LABETALOL HYDROCHLORIDE →fda approvals ↗

Mar 26, 2026approval145d agoDOXYCYCLINE HYCLATE — FDA approvalDOXYCYCLINE HYCLATE

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

full page →DOXYCYCLINE HYCLATE →fda approvals ↗

Mar 26, 2026approval145d agoDOXYCYCLINE HYCLATE — FDA approvalDOXYCYCLINE HYCLATE

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

full page →DOXYCYCLINE HYCLATE →fda approvals ↗

Mar 26, 2026approval145d agoPAROXETINE HYDROCHLORIDE — FDA approvalPAROXETINE HYDROCHLORIDE

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

full page →PAROXETINE HYDROCHLORIDE →fda approvals ↗

Mar 26, 2026approval145d agoNEFFY (EPINEPHRINE) — FDA approvalInternational Medication Systems Ltd

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

full page →fda approvals ↗

Mar 26, 2026approval145d agoNEFFY (EPINEPHRINE) — FDA approvalInternational Medication Systems Ltd

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

full page →fda approvals ↗

Mar 26, 2026approval145d agoTAFINLAR (DABRAFENIB MESYLATE) — FDA approvaldabrafenib mesylate ODT

Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL

full page →dabrafenib mesylate ODT →fda approvals ↗

Mar 26, 2026device 510k145d 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 510k145d 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 510k145d 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 510k145d 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 510k145d 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 510k145d 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 ↗

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Week of Mar 23, 2026