Calendar

Week of Mar 9, 2026

Mar 11, 2026recall159d agoACME UNITED CORPORATION recall (Cls II)ACME UNITED CORP

Green Guard Antiseptic Wipes (Benzalkonium Chloride 0.13%), 25 wipes per box, Distributed by Green Guard, St. Louis, MO 63045, NDC 47682-056-73 — Reason: CGMP Deviations — Status: Ongoing

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Mar 11, 2026recall159d agoTeva Pharmaceuticals USA, Inc recall (Cls II)Terns Pharmaceuticals, Inc.

Metoprolol Succinate Extended-Release Tablets, 200 mg, 100 tablets bottles, Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054, NDC: 45963-678-11 — Reason: Failed Dissolution Specifications — Status: Ongoing

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Mar 11, 2026recall159d agoACME UNITED CORPORATION recall (Cls II)ACME UNITED CORP

Cleansing Towelette (Benzalkonium Chloride 0.13%), 5"x 7", 1,000 case/Bulk, Med-Nap, Brooksville, FL 34601, Made in USA, NDC 0924-0243-00. — Reason: CGMP Deviations — Status: Ongoing

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Mar 11, 2026recall159d agoACME UNITED CORPORATION recall (Cls II)ACME UNITED CORP

WP WipesPlus Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 5x7, 100 CT, Progressive Products, 211 S. Ridge Street, Rye Brook, NY 10573. NDC 67151-727-01. — Reason: CGMP Deviations — Status: Ongoing

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Mar 11, 2026recall159d agoACME UNITED CORPORATION recall (Cls II)ACME UNITED CORP

1) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5"x7" Piedmont Sanitizing Hand Wipes, 1,000 ea Bulk, Made in USA for: Food Service Resources, Flowery Branch, GA 30542, NDC 0924-7130-00. 2) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5" x 7" Touchpoint, 1000 ea Bulk, Made in USA for : Food Service Resources, Flowery Branch, GA 30542. NDC 0924-7130-00. 3) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5" x 7" Wellstar Cobb Hand Wipes, 1000 ea Bulk, Made in the USA for Food Service Resources, Flowery Branch, GA 30542, NDC 0924-7130-00. 4) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5" x 7" FSR Sanitizing Hand Wipes, 1000 ea Bulk, Made in USA for Food Service Resources, Flowery Branch, GA 30542, NDC 0924-7130-00. Inner Packaging - Instant Hand Sanitizing Wipes 5) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5" x7" Children's 1000 ea Bulk, Made in USA for: Food Service Resources, Flowery Branch, GA 30542 NDC 0924-713-00. Inner packaging -Children's Healthcare of Atlanta — Reason: CGMP Deviations — Status: Ongoing

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Mar 11, 2026recall159d agoTeva Pharmaceuticals USA, Inc recall (Cls II)Terns Pharmaceuticals, Inc.

Metoprolol Succinate Extended-Release Tablets, Rx Only, 100 mg, 100 tablets bottles (NDC: 45963-677-11) and 1,000 tablets bottles (NDC: 45963-677-96), Teva Pharmaceuticals, Parsippany, NJ 07054. — Reason: Failed Dissolution Specifications — Status: Ongoing

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Mar 11, 2026recall159d agoACME UNITED CORPORATION recall (Cls II)ACME UNITED CORP

Children's Healthcare of Atlanta, Instant Hand Sanitizing Wipe(Benzalkonium Chloride 0.13%), 1000 per case, Made in USA for Food Service Resources, Flowery Branch, GA 30542, NDC 0924-7130-00 — Reason: CGMP Deviations — Status: Ongoing

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Mar 11, 2026recall159d agoANTHONY TRINH, 123Herbals LLC recall (Cls I)Viatris Inc

SILINTAN 25/pills, packaged in a 25-count bottle, Shanghai Chinese Medical Works, Shanghai, China — Reason: Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam. — Status: Ongoing

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Mar 11, 2026device 510k159d agoHuizhou Foryou Medical Co., Ltd. — LUOFUCON® Antimicrobial Wound Gel (510k cleared)

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

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Mar 11, 2026device 510k159d agoDepuy Ireland UC — INHANCE Reverse Shoulder System (510k cleared)

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

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Mar 11, 2026device 510k159d agoShenzhen Chuangtong Yigou Technology Co., Ltd. — Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07, CTU09, CTU012, CTU015, CTU X, DT015 Pro, DT015, DT017 Pro, DT017, DT025 Pro, DT025) (510k cleared)

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

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Mar 11, 2026device 510k159d agoRiverpoint Medical, LLC — Strut Suture; No-Tie Button (510k cleared)

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

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Mar 11, 2026device 510k159d agoKulzer, LLC — Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One (510k cleared)

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

full page →fda device 510k ↗

Mar 11, 2026device 510k159d agoNewclip Technics — Xpert Hand (510k cleared)

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

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Mar 11, 2026device 510k159d agoLivaNova USA, Inc. — Venous Return Cannulae (510k cleared)

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

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Mar 11, 2026device 510k159d agoIntuitive Surgical, Inc. — da Vinci Force Feedback Instruments (510k cleared)INTUITIVE SURGICAL INC

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

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Mar 11, 2026device 510k159d agoCarestream Health — Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System (510k cleared)

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

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Mar 11, 2026device 510k159d agoCAO Group, Inc. — Picasso Pro Diode Laser (002-00460) (510k cleared)CAVA GROUP, INC.

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

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Mar 11, 2026device pma159d agoAlcon Laboratories, Inc. — Precision7; Precision7 for Astigmatism; Precision7 Multifocal (PMA supplement)Alcon Laboratories Inc

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

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Mar 11, 2026device pma159d agoEdwards Lifesciences, LLC — Edwards EVOQUE Heart Valve (sizes 44mm, 46mm, 48mm, 52mm) (PMA supplement)Edwards Lifesciences Corp

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

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Mar 11, 2026device pma159d agoJohnson & Johnson Surgical Vision, Inc. — TECNIS PureSee IOL, Model DEN00V TECNIS PureSee Toric II IOLs, Model DET150, DET225, DET300, DET375 (PMA supplement)JOHNSON & JOHNSON

Supplement type: Panel Track. Product code: HQL. Advisory committee: OP. Decision: APPR

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Mar 11, 2026device pma159d agoEdwards Lifesciences, LLC — Edwards SAPIEN 3 Transcatheter Heart Valve; Edwards SAPIEN 3 Ultra Transcatheter Heart Valve; Edwards SAPIEN 3 Ultra (PMA supplement)Edwards Lifesciences Corp

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

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Mar 11, 2026device pma159d agoEdwards Lifesciences, LLC — Edwards SAPIEN M3 Transcatheter Heart Valve (sizes 20mm, 23mm, 26mm, 29mm) (PMA supplement)Edwards Lifesciences Corp

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

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Mar 11, 2026device pma159d agoEdwards Lifesciences, LLC — INSPIRIS RESILIA Aortic Valve; KONECT RESILIA Aortic Valve Conduit (AVC); MITRIS RESILIA Mitral Valve (PMA supplement)Edwards Lifesciences Corp

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

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Mar 11, 2026device pma159d agoEdwards Lifesciences, LLC — Carpentier-Edwards PERIMOUNT Theon RSR Pericardial Aortic Bioprosthesis with ThermaFix® tissue process; Carpentier-Edwar (PMA supplement)Edwards Lifesciences Corp

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

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

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Mar 11, 2026device pma159d agoEdwards Lifesciences, LLC — Edwards SAPIEN 3 Transcatheter Heart Valve (PMA supplement)Edwards Lifesciences Corp

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

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Mar 11, 2026device pma159d agoMedtronic Vascular, Inc. — VenaSeal Closure System (PMA supplement)

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

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Mar 11, 2026grant159d agoLEHIGH UNIVERSITY — 3D-Printed Scaffolds with Independently Tunable Multiscale Properties

EB grant. $72,965. PI: Lesley W Chow

full page →nih reporter ↗

Mar 11, 2026grant159d agoDUKE UNIVERSITY — Geriatric oncology assessment to link with support for older women taking adj...Duke University

CA grant. $668,691. PI: Gretchen Kimmick

full page →nih reporter ↗

Mar 11, 2026grant159d agoNEW JERSEY INSTITUTE OF TECHNOLOGY — Engineering an in vitro 3D tissue construct to study peripheral nerve regener...

NS grant. $553,292. PI: Jonathan M. Grasman

full page →nih reporter ↗

Mar 11, 2026grant159d agoUNIVERSITY OF MICHIGAN AT ANN ARBOR — Novel Multi-targeted Strategies Targeting T-cell Lymphomas and their Microenv...

CA grant. $646,920. PI: Ryan A Wilcox

full page →nih reporter ↗

Mar 11, 2026grant159d agoHARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH — Novel Methods for Joint Prediction in the presence of mortality

HL grant. $43,560. PI: Stephanie Armbruster

full page →nih reporter ↗

Mar 11, 2026grant159d agoUNIVERSITY OF MISSOURI-COLUMBIA — Multimodal, Porous, Starfish-Like Soft Wearable Bioelectronic Systems for Mot...

EB grant. $597,977. PI: Zheng Yan

full page →nih reporter ↗

Mar 11, 2026grant159d agoUTAH STATE HIGHER EDUCATION SYSTEM--UNIVERSITY OF UTAH — PULSE (Program Understanding and Learning through Strategic Evaluation)University of Utah

GM grant. $105,987. PI: Janet Iwasa

full page →nih reporter ↗

Mar 11, 2026grant159d agoLSU PENNINGTON BIOMEDICAL RESEARCH CTR — Breath Biomarkers of Disease and Health Outcomes (BREATHE OUT)

GM grant. $225,000. PI: Jacob T Mey

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Mar 12, 2026approval158d agoCOSENTYX (SECUKINUMAB) — FDA approvalNOVARTIS AG

Sponsor: NOVARTIS PHARMS CORP. Form: INJECTABLE. Route: INJECTION

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Mar 12, 2026approval158d agoCOSENTYX (SECUKINUMAB) — FDA approvalNOVARTIS AG

Sponsor: NOVARTIS PHARMS CORP. Form: INJECTABLE. Route: INJECTION

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Mar 12, 2026approval158d agoPROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN HYDROBROMIDE) — FDA approvalPROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE

Sponsor: HETERO LABS LTD III. Form: SYRUP. Route: ORAL

full page →PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE →fda approvals ↗

Mar 12, 2026approval158d agoTRULICITY (DULAGLUTIDE) — FDA approvaldulaglutide

Sponsor: ELI LILLY AND CO. Form: INJECTABLE. Route: INJECTION

full page →dulaglutide →fda approvals ↗

Mar 12, 2026approval158d agoSOLIQUA 100/33 (INSULIN GLARGINE) — FDA approvalToujeo LA

Sponsor: SANOFI-AVENTIS US. Form: SOLUTION. Route: SUBCUTANEOUS

full page →Toujeo LA →fda approvals ↗

Mar 12, 2026approval158d agoPOTASSIUM PHOSPHATES (POTASSIUM PHOSPHATE, DIBASIC) — FDA approvalHospira Inc

Sponsor: CAPLIN. Form: SOLUTION. Route: INTRAVENOUS

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Mar 12, 2026approval158d agoFINGOLIMOD HYDROCHLORIDE — FDA approvalFINGOLIMOD HYDROCHLORIDE

Sponsor: BIOCON LTD. Form: CAPSULE. Route: ORAL

full page →FINGOLIMOD HYDROCHLORIDE →fda approvals ↗

Mar 12, 2026approval158d agoFINGOLIMOD HYDROCHLORIDE — FDA approvalFINGOLIMOD HYDROCHLORIDE

Sponsor: BIOCON LTD. Form: CAPSULE. Route: ORAL

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Mar 12, 2026approval158d agoADLYXIN (LIXISENATIDE) — FDA approvalADLYXIN

Sponsor: SANOFI-AVENTIS US. Form: SOLUTION. Route: SUBCUTANEOUS

full page →ADLYXIN →fda approvals ↗

Mar 12, 2026approval158d agoSUNLENCA (LENACAPAVIR SODIUM) — FDA approvallenacapavir sodium LA

Sponsor: GILEAD SCIENCES INC. Form: SOLUTION. Route: SUBCUTANEOUS

full page →lenacapavir sodium LA →fda approvals ↗

Mar 12, 2026approval158d agoSUNLENCA (LENACAPAVIR SODIUM) — FDA approvallenacapavir sodium LA

Sponsor: GILEAD SCIENCES INC. Form: TABLET. Route: ORAL

full page →lenacapavir sodium LA →fda approvals ↗

Mar 12, 2026approval158d agoPOMALIDOMIDE — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: TEVA PHARMS USA. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Mar 12, 2026device 510k158d agoHsiner Co., Ltd. — VPAP Pediatric Face Mask (510k cleared)

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

full page →fda device 510k ↗

Mar 12, 2026device 510k158d agoInvera Medical — InVera Infusion Device (510k cleared)

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

full page →fda device 510k ↗

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Week of Mar 9, 2026