Calendar

Week of Mar 16, 2026

Mar 18, 2026device 510k153d agoLimFlow, Inc. — LimFlow Vector (510k cleared)

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

Mar 18, 2026device 510k153d agoVarian Medical Systems, Inc. — syngo.via RT Image Suite VC10 (510k cleared)MERIT MEDICAL SYSTEMS INC

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

full page →fda device 510k ↗

Mar 18, 2026device 510k153d agoO&M Halyard, Inc. — HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround Visor (510k cleared)

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

full page →fda device 510k ↗

Mar 18, 2026device 510k153d agoMedShape, Inc. — DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro (510k cleared)

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

full page →fda device 510k ↗

Mar 18, 2026device 510k153d agoVision Rt, Ltd. — AlignRT Plus (8.0) (510k cleared)Rail Vision Ltd.

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

full page →fda device 510k ↗

Mar 18, 2026device 510k153d agoFusion Orthopedics USA, LLC — Fusion FibFix Nail (510k cleared)

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

full page →fda device 510k ↗

Mar 18, 2026device 510k153d agoMiRus, LLC — EUROPA Posterior Cervical Fusion Navigated Instruments (510k cleared)

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

full page →fda device 510k ↗

Mar 18, 2026device 510k153d agoNingbo Medsun Medical Co., Ltd. — Safety Pen Needle (510k cleared)

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

full page →fda device 510k ↗

Mar 18, 2026device 510k153d agoSangi Co., Ltd. — APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste) (510k cleared)SanBio Co Ltd

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

full page →fda device 510k ↗

Mar 18, 2026device 510k153d agoCarl Zeiss Vision GmbH — VISUREF 600 (510k cleared)

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

full page →fda device 510k ↗

Mar 18, 2026device pma153d agoMedtronic Neuromodulation — InterStim® Therapy System, Verify® Evaluation System (SNS Urinary Neurostimulator) (PMA supplement)

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

full page →fda device pma ↗

Mar 18, 2026device pma153d agoMerz North America, Inc. — RADIESSE® Injectable Implant (PMA supplement)

Supplement type: 30-Day Notice. Product code: LMH. Advisory committee: SU. Decision: OK30

full page →fda device pma ↗

Mar 18, 2026device pma153d agoBoston Scientific — INGEVITY+ Pace / Sense Lead Tined Fixation Models 7831 (52 cm, Straight) 7832 (59 cm, Straight) 7835 (45 cm, Atrial J (PMA supplement)BOSTON SCIENTIFIC CORP

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

full page →fda device pma ↗

Mar 18, 2026device pma153d agoMedtronic Neuromodulation — InterStim® Therapy System, Verify® Evaluation System (SNS Bowel Neurostimulator) (PMA supplement)

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

full page →fda device pma ↗

Mar 18, 2026device pma153d agoMerz North America, Inc. — COAPTITE® Injectable Implant (PMA supplement)

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

full page →fda device pma ↗

Mar 18, 2026device pma153d agoMerz North America, Inc. — RADIESSE® Injectable Implant (PMA supplement)

Supplement type: 30-Day Notice. Product code: LMH. Advisory committee: SU. Decision: OK30

full page →fda device pma ↗

Mar 18, 2026device pma153d 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

full page →fda device pma ↗

Mar 18, 2026device pma153d agoLivaNova USA, Inc. — aura6000 system (PMA)

Product code: MNQ. Advisory committee: AN. Decision: APPR

full page →fda device pma ↗

Mar 18, 2026device pma153d agoCarl Zeiss Meditec Production, LLC — CT LUCIA 602; CT LUCIA 202; CT LUCIA 611P; CT LUCIA 621P (PMA supplement)

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

full page →fda device pma ↗

Mar 18, 2026grant153d agoCALIFORNIA STATE UNIVERSITY NORTHRIDGE — Expanding Access to Digital Health Technologies Through Equity-Centered Engin...

EB grant. $21,072. PI: Thomas Chan

full page →nih reporter ↗

Mar 18, 2026grant153d agoSMITH COLLEGE — Effects of children's early experience with varying parental styles on the ne...

HD grant. $527,648. PI: Maya Rosen

full page →nih reporter ↗

Mar 18, 2026grant153d agoDUKE UNIVERSITY — Mechanisms of microbial regulation of postnatal growth and lipid metabolismDuke University

DK grant. $612,587. PI: Noelle Elizabeth Younge

full page →nih reporter ↗

Mar 18, 2026grant153d agoMASSACHUSETTS INSTITUTE OF TECHNOLOGY — Life-spanning study of Polycomb regulation by cohesin

AG grant. $51,038. PI: Emily Navarrete

full page →nih reporter ↗

Mar 18, 2026grant153d agoUNIVERSITY OF CONNECTICUT SCH OF MED/DNT — Investigating Dead Cell-Phagocyte Interaction at the Phagosomal Interface to ...

GM grant. $423,352. PI: Kai Li

full page →nih reporter ↗

Mar 18, 2026grant153d agoJOHNS HOPKINS UNIVERSITY — Mechanobiological regulations of collective cell movement: insights from in v...Johns Hopkins University

GM grant. $412,124. PI: Shinuo Weng

full page →nih reporter ↗

Mar 18, 2026grant153d agoUNIVERSITY OF CALIFORNIA, SAN DIEGO — Targeting Lethal mCRPC with siRNA TherapeuticsUniversity of California San Diego

CA grant. $410,933. PI: STEVEN F DOWDY

full page →nih reporter ↗

Mar 18, 2026grant153d agoUNIVERSITY OF PITTSBURGH AT PITTSBURGH — Epigenetic Regulation of Hypothalamic Energy Homeostasis

DK grant. $664,240. PI: Isin Cakir

full page →nih reporter ↗

Mar 18, 2026grant153d agoAUBURN UNIVERSITY AT MONTGOMERY — BRE-SPAD at Auburn University at Montgomery

GM grant. $554,945. PI: Douglas W Leaman

full page →nih reporter ↗

Mar 18, 2026grant153d agoUNIVERSITY OF PITTSBURGH AT PITTSBURGH — Novel targeted combinatorial therapy for castration-resistant prostate cancer

CA grant. $658,492. PI: Song Li

full page →nih reporter ↗

Mar 18, 2026grant153d agoUT SOUTHWESTERN MEDICAL CENTER — Lipid Droplets

DK grant. $25,000. PI: Mike Henne

full page →nih reporter ↗

Mar 18, 2026grant153d agoUNIVERSITY OF CALIFORNIA, SAN DIEGO — Progressive Clinical Team-Based Design and Skill-Building Across All Undergra...University of California San Diego

EB grant. $21,600. PI: Reem Khojah

full page →nih reporter ↗

Mar 18, 2026grant153d agoSTANFORD UNIVERSITY — Threading the needle: Development of Novel MR Methods for Effective Control o...Stanford University

CA grant. $593,557. PI: Lawrence D Recht

full page →nih reporter ↗

Mar 18, 2026grant153d agoUNIVERSITY OF MARYLAND BALTIMORE — Associations between actigraphy-derived circadian rest-activity rhythms and c...

CA grant. $411,334. PI: Amber Simmons Kleckner

full page →nih reporter ↗

Mar 19, 2026approval152d agoDUOPA (CARBIDOPA) — FDA approvalcarbidopa

Sponsor: ABBVIE. Form: SUSPENSION. Route: ENTERAL

full page →carbidopa →fda approvals ↗

Mar 19, 2026approval152d agoRIFAXIMIN — FDA approvalSalix Pharmaceuticals Ltd

Sponsor: ACTAVIS LABS FL INC. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Mar 19, 2026approval152d agoRIFABUTIN — FDA approvali3 Pharmaceuticals LLC

Sponsor: I3 PHARMS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Mar 19, 2026approval152d agoSTALEVO 75 (CARBIDOPA) — FDA approvalcarbidopa

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

full page →carbidopa →fda approvals ↗

Mar 19, 2026approval152d agoVYALEV (FOSCARBIDOPA) — FDA approval(foscarbidopa + foslevodopa)

Sponsor: ABBVIE. Form: SOLUTION. Route: SUBCUTANEOUS

full page →(foscarbidopa + foslevodopa) →fda approvals ↗

Mar 19, 2026approval152d agoWEGOVY (SEMAGLUTIDE) — FDA approvalNovo Nordisk AS

Sponsor: NOVO. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Mar 19, 2026approval152d agoOPUVIZ (AFLIBERCEPT-YSZY) — FDA approvalOPUVIZ

Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: INJECTION

full page →OPUVIZ →fda approvals ↗

Mar 19, 2026approval152d agoVALGANCICLOVIR HYDROCHLORIDE — FDA approvalVALGANCICLOVIR HYDROCHLORIDE

Sponsor: MICRO LABS. Form: FOR SOLUTION. Route: ORAL

full page →VALGANCICLOVIR HYDROCHLORIDE →fda approvals ↗

Mar 19, 2026approval152d agoWEGOVY (SEMAGLUTIDE) — FDA approvalNovo Nordisk AS

Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS

full page →fda approvals ↗

Mar 19, 2026approval152d agoFLAVALTA (EPINEPHRINE BITARTRATE) — FDA approvalDe Motu Cordis Pty Ltd

Sponsor: DEPROCO. Form: SOLUTION. Route: INJECTION

full page →fda approvals ↗

Mar 19, 2026approval152d agoDHIVY (CARBIDOPA) — FDA approvalAvion Pharmaceuticals LLC

Sponsor: AVION PHARMS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Mar 19, 2026approval152d agoRYTARY (CARBIDOPA) — FDA approvalOrganon & Co.

Sponsor: IMPAX. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Mar 19, 2026approval152d agoDEXMETHYLPHENIDATE HYDROCHLORIDE — FDA approvaldexmethylphenidate hydrochloride ER

Sponsor: AUROLIFE PHARMA LLC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →dexmethylphenidate hydrochloride ER →fda approvals ↗

Mar 19, 2026approval152d agoDEXMETHYLPHENIDATE HYDROCHLORIDE — FDA approvaldexmethylphenidate hydrochloride ER

Sponsor: AUROLIFE PHARMA LLC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →dexmethylphenidate hydrochloride ER →fda approvals ↗

Mar 19, 2026approval152d agoDEXMETHYLPHENIDATE HYDROCHLORIDE — FDA approvaldexmethylphenidate hydrochloride ER

Sponsor: AUROLIFE PHARMA LLC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →dexmethylphenidate hydrochloride ER →fda approvals ↗

Mar 19, 2026approval152d agoSINEMET CR (CARBIDOPA) — FDA approvalcarbidopa

Sponsor: ORGANON LLC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →carbidopa →fda approvals ↗

Mar 19, 2026approval152d agoCREXONT (CARBIDOPA) — FDA approvalOrganon & Co.

Sponsor: IMPAX. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

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Week of Mar 16, 2026