Calendar

Week of Mar 16, 2026

Mar 17, 2026device 510k153d agoA Plus Biotechnology Co., Ltd. — APS Spear Locking Plate (510k cleared)Avistone Biotechnology Co Ltd

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

full page →fda device 510k ↗

Mar 17, 2026device 510k153d agoGM Dos Reis Industria e Comercio Ltda. — Super Upper Limbs Versalock Plating System (510k cleared)

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

full page →fda device 510k ↗

Mar 17, 2026device 510k153d agoParagon 28, Inc. — Grappler Suture Anchor PCFD Tether System (510k cleared)

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

full page →fda device 510k ↗

Mar 17, 2026device 510k153d agoLerado Zhongshan Peaceful Cove Business Trading Co., Ltd. — Electrical Scooter (SM4226) (510k cleared)

Product code: INI. Advisory committee: Physical Medicine. Type: Traditional

full page →fda device 510k ↗

Mar 17, 2026device 510k153d agoSerim Research — GUARDIAN Quick Dip Residual Chlorine (5212) (510k cleared)

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

full page →fda device 510k ↗

Mar 17, 2026device 510k153d agoC.R. Bard, Inc. — Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories) (510k cleared)

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

full page →fda device 510k ↗

Mar 17, 2026device 510k153d agoPhilips Medical Systems Nederland B.V. — EchoNavigator R5.0 (510k cleared)

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

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Mar 17, 2026device 510k153d agoCala Health, Inc. — Cala kIQ Plus (510k cleared)CARDINAL HEALTH INC

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

full page →fda device 510k ↗

Mar 17, 2026device 510k153d agoK2m, Inc. — Q Pedicle Instruments (510k cleared)

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

full page →fda device 510k ↗

Mar 17, 2026device pma153d agoRoche — cobas® EGFR Mutation Test, v2.0 (PMA supplement)

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

full page →fda device pma ↗

Mar 17, 2026device pma153d agoRoche Molecular Systems, Inc. — cobas® HPV (PMA supplement)

Supplement type: 30-Day Notice. Product code: MAQ. Advisory committee: MI. Decision: OK30

full page →fda device pma ↗

Mar 17, 2026device pma153d agoPulmonx Corporation — Zephyr Endobronchial Valve (EBV) System (PMA supplement)Pulmonx Corp

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

full page →fda device pma ↗

Mar 17, 2026device pma153d agoABBOTT MEDICAL — Navitor Transcatheter Aortic Valve Implantation System (PMA supplement)

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

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Mar 17, 2026device pma153d agoJenaValve Technology, Inc. — Trilogy Transcatheter Heart Valve System (PMA)

Product code: NPT. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗

Mar 17, 2026device pma153d agoRoche Molecular Systems, Inc. — cobas® HPV (PMA supplement)

Supplement type: 30-Day Notice. Product code: MAQ. Advisory committee: MI. Decision: OK30

full page →fda device pma ↗

Mar 17, 2026device pma153d agoRoche Molecular Systems, Inc. — cobas® BRAF V600 Mutation Test (PMA supplement)

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

full page →fda device pma ↗

Mar 17, 2026device pma153d agoRoche Molecular System, Inc. — cobas® EZH2 Mutation Test (PMA supplement)

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

full page →fda device pma ↗

Mar 17, 2026device pma153d agoRoche Molecular Systems, Inc. — cobas® KRAS Mutation Test (PMA supplement)

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

full page →fda device pma ↗

Mar 17, 2026device recall153d agoStraumann USA LLC device recall (Cls II)

Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620; — Reason: A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorrectly identified as a Titanium Bar Ti Gr4 D (SAP #701922 / Lot 7130430). As a result, RC Titanium abutments were manufactured using the TAN Bar material on Mill-from-Bar Machine 396-06. — Status: Ongoing

full page →fda device recalls ↗

Mar 17, 2026device recall153d agoStraumann USA LLC device recall (Cls II)

Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438; — Reason: A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorrectly identified as a Titanium Bar Ti Gr4 D (SAP #701922 / Lot 7130430). As a result, RC Titanium abutments were manufactured using the TAN Bar material on Mill-from-Bar Machine 396-06. — Status: Ongoing

full page →fda device recalls ↗

Mar 17, 2026grant153d agoHANNOVER MEDICAL SCHOOL — The growth factor meteorin-like and its receptor KIT in heart failure

HL grant. $29,270. PI: Lillian Hyde

full page →nih reporter ↗

Mar 17, 2026grant153d agoUNIVERSITY OF CALIFORNIA BERKELEY — Robust and Scalable Machine Learning and Statistical Methods for Genomics

GM grant. $510,183. PI: Yun S Song

full page →nih reporter ↗

Mar 17, 2026grant153d agoUNIVERSITY OF ROCHESTER — A small molecule PROTAC for macular degenerationUniversity of Rochester

NS grant. $744,451. PI: Ruchira Singh

full page →nih reporter ↗

Mar 17, 2026grant153d agoDUKE UNIVERSITY — Epithelial actions of a ubiquitin editor restrict immune-regulated sodium tra...Duke University

DK grant. $821,618. PI: Steven D Crowley

full page →nih reporter ↗

Mar 17, 2026grant153d agoUNIV OF NORTH CAROLINA CHAPEL HILL — Leveraging Inpatient records to characterize the HIV Care continuum in North ...

MH grant. $1,177,156. PI: Thibaut Davy-Mendez

full page →nih reporter ↗

Mar 17, 2026grant153d agoUNIVERSITY OF WASHINGTON — Adaptive Neural control of Respiration in DrosophilaUniversity of Washington

NS grant. $122,769. PI: Yichen Luo

full page →nih reporter ↗

Mar 17, 2026grant153d agoHANNOVER MEDICAL SCHOOL — The growth factor meteorin-like and its receptor KIT in heart failure

HL grant. $4,750. PI: Lillian Hyde

full page →nih reporter ↗

Mar 17, 2026grant153d agoUNIVERSITY OF CONNECTICUT STORRS — Implantable, Degradable Drug Delivery Devices for Non-Opioid Post-Surgical Pa...

EB grant. $39,349. PI: Kelly Anne Burke

full page →nih reporter ↗

Mar 17, 2026grant153d agoBRIGHAM AND WOMEN'S HOSPITAL — SocialBit2: High-fidelity Mobile Sensing of Social Connection after StrokeBrigham and Women's Hospital

NS grant. $716,816. PI: Amar Dhand

full page →nih reporter ↗

Mar 17, 2026grant153d agoYALE UNIVERSITY — Plasma-derived astrocyte-enriched exosomes as a platform for ALS patient stra...

NS grant. $461,197. PI: David Pitt

full page →nih reporter ↗

Mar 17, 2026grant153d agoUNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON — Systemic Lipid Metabolism After Aneurysmal Subarachnoid Hemorrhage (SLIM-SAH)

NS grant. $632,144. PI: Aaron Mark Gusdon

full page →nih reporter ↗

Mar 17, 2026grant153d agoUNIVERSITY OF CONNECTICUT SCH OF MED/DNT — Transposon-mediated genetic manipulation of OPCs to study their role in synap...

NS grant. $471,861. PI: David Christopher Martinelli

full page →nih reporter ↗

Mar 18, 2026approval152d agoVIGABATRIN — FDA approvalPyros Pharmaceuticals Inc.

Sponsor: PH HEALTH. Form: FOR SOLUTION. Route: ORAL

full page →fda approvals ↗

Mar 18, 2026approval152d agoMYCOPHENOLATE MOFETIL — FDA approvalMYCOPHENOLATE MOFETIL

Sponsor: AUROBINDO PHARMA LTD. Form: FOR SUSPENSION. Route: ORAL

full page →MYCOPHENOLATE MOFETIL →fda approvals ↗

Mar 18, 2026approval152d agoVIGABATRIN — FDA approvalVIGABATRIN

Sponsor: AUROBINDO PHARMA LTD. Form: TABLET. Route: ORAL

full page →VIGABATRIN →fda approvals ↗

Mar 18, 2026approval152d agoVIGABATRIN — FDA approvalPyros Pharmaceuticals Inc.

Sponsor: UPSHER SMITH LABS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Mar 18, 2026approval152d agoSKYRIZI (RISANKIZUMAB-RZAA) — FDA approvalrisankizumab

Sponsor: ABBVIE INC. Form: INJECTABLE. Route: INTRAVENOUS

full page →risankizumab →fda approvals ↗

Mar 18, 2026approval152d agoIOPIDINE (APRACLONIDINE HYDROCHLORIDE) — FDA approvalHARROW, INC.

Sponsor: HARROW EYE. Form: SOLUTION/DROPS. Route: OPHTHALMIC

full page →fda approvals ↗

Mar 18, 2026approval152d agoXTORO (FINAFLOXACIN) — FDA approval

Sponsor: FONSECA BIOSCIENCES. Form: SUSPENSION/DROPS. Route: OTIC

full page →fda approvals ↗

Mar 18, 2026approval152d agoXTORO (FINAFLOXACIN) — FDA approval

Sponsor: FONSECA BIOSCIENCES. Form: SUSPENSION/DROPS. Route: OTIC

full page →fda approvals ↗

Mar 18, 2026approval152d agoVIGABATRIN — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

Mar 18, 2026approval152d agoBUSULFAN — FDA approvalWoodward Pharma Services LLC

Sponsor: ACTAVIS. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Mar 18, 2026approval152d agoPAROXETINE MESYLATE — FDA approvalLegacy Pharma Solutions

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

full page →fda approvals ↗

Mar 18, 2026approval152d agoIOPIDINE (APRACLONIDINE HYDROCHLORIDE) — FDA approvalHARROW, INC.

Sponsor: HARROW EYE. Form: SOLUTION/DROPS. Route: OPHTHALMIC

full page →fda approvals ↗

Mar 18, 2026approval152d agoVIGABATRIN — FDA approvalVIGABATRIN

Sponsor: ACCORD HLTHCARE. Form: FOR SOLUTION. Route: ORAL

full page →VIGABATRIN →fda approvals ↗

Mar 18, 2026approval152d agoLISDEXAMFETAMINE DIMESYLATE — FDA approvalLISDEXAMFETAMINE DIMESYLATE

Sponsor: ASCENT PHARMS INC. Form: CAPSULE. Route: ORAL

full page →LISDEXAMFETAMINE DIMESYLATE →fda approvals ↗

Mar 18, 2026approval152d agoVIGABATRIN — FDA approvalVIGABATRIN

Sponsor: ZYDUS LIFESCIENCES. Form: TABLET. Route: ORAL

full page →VIGABATRIN →fda approvals ↗

Mar 18, 2026approval152d agoATROPINE SULFATE — FDA approvalATROPINE SULFATE

Sponsor: ACCORD HLTHCARE. Form: SOLUTION. Route: INTRAVENOUS

full page →ATROPINE SULFATE →fda approvals ↗

Mar 18, 2026approval152d agoTRANEXAMIC ACID — FDA approvalZydus Therapeutics Inc

Sponsor: ZYDUS PHARMS. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Mar 18, 2026approval152d agoSABRIL (VIGABATRIN) — FDA approvalVIGABATRIN

Sponsor: LUNDBECK PHARMS LLC. Form: TABLET. Route: ORAL

full page →VIGABATRIN →fda approvals ↗

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Week of Mar 16, 2026