Calendar

Week of Jan 26, 2026

Jan 29, 2026device 510k195d agoHiossen, Inc. — EK MULTI ANGLED 30 ABUTMENT (510k cleared)

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

Jan 29, 2026device 510k195d agoMedtox Diagnostics, Inc. — Labcorp Fentanyl Urine Visual Test (510k cleared)Co-Diagnostics, Inc.

Product code: DJG. Advisory committee: Clinical Toxicology. Type: Traditional

full page →fda device 510k ↗

Jan 29, 2026device 510k195d agoFresenius Medical Care Renal Therapies Group, LLC — NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) (510k cleared)Fresenius Medical Care AG

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

full page →fda device 510k ↗

Jan 29, 2026device 510k195d agoConmed Corporation — Y-Knotless Flex Anchors (510k cleared)CONMED Corp

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

full page →fda device 510k ↗

Jan 29, 2026device 510k195d agoJiangsu Jumao X-Care Medical Equipment Co., , Ltd. — Manual Wheelchair (W50) (510k cleared)

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

full page →fda device 510k ↗

Jan 29, 2026device pma195d agoQ-Med AB — Restylane®-L 1 mL; Restylane® Lyft with Lidocaine 1 mL; Restylane® Eyelight 0.5 mL (PMA supplement)Sustained Therapeutics Inc

Supplement type: Normal 180 Day Track. Product code: LMH. Advisory committee: SU. Decision: APPR

full page →fda device pma ↗

Jan 29, 2026device pma195d agoVascutek, Ltd. — Thoraflex Hybrid (PMA supplement)

Supplement type: Special (Immediate Track). Product code: QSK. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗

Jan 29, 2026device pma195d agoAutoGenomics, Inc. — AvertD and AvertD Buccal Sample Collection Kit (PMA supplement)NEOGENOMICS INC

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

full page →fda device pma ↗

Jan 29, 2026device pma195d agoZoll Manufacturing Corporation — LifeVest® Wearable Defibrillator (PMA supplement)

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

full page →fda device pma ↗

Jan 29, 2026device pma195d agoHighridge Medical, LLC — activL Artificial Disc (PMA supplement)

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

full page →fda device pma ↗

Jan 29, 2026device recall195d agoOlympus Corporation of the Americas device recall (Cls II)

Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent reflux of body fluids. — Reason: Potential for rubber fragment detachment during use. — Status: Ongoing

full page →fda device recalls ↗

Jan 29, 2026device recall195d agoOlympus Corporation of the Americas device recall (Cls II)

Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The MAJ-1218 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent leakage of body fluids. — Reason: Potential for rubber fragment detachment during use. — Status: Ongoing

full page →fda device recalls ↗

Jan 29, 2026device recall195d agoReCor Medical Inc. device recall (Cls II)VYCOR MEDICAL INC

Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Model/Catalog Number: PRDS-068-02 Product Description: Common name: Ablation catheter renal denervation — Reason: Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use. — Status: Ongoing

full page →fda device recalls ↗

Jan 29, 2026device recall195d agoReCor Medical Inc. device recall (Cls II)VYCOR MEDICAL INC

full page →fda device recalls ↗

Jan 29, 2026grant195d agoUNIVERSITY OF PENNSYLVANIA — Organizational Changes to Reduce Nurse BurnoutUniversity of Pennsylvania

NR grant. $2,009,207. PI: Karen Blanchette Lasater

full page →nih reporter ↗

Jan 29, 2026grant195d agoNEW YORK UNIVERSITY SCHOOL OF MEDICINE — The role of CD69 in established resident memory T cellsNew York University

AI grant. $466,125. PI: Susan Ruth Schwab

full page →nih reporter ↗

Jan 29, 2026grant195d agoUNIVERSITY OF NEBRASKA MEDICAL CENTER — Interplay Between Transcription and ATP-dependent Chromatin Remodeling for Ge...

GM grant. $280,905. PI: Sandipan Brahma

full page →nih reporter ↗

Jan 30, 2026approval194d agoZYPREXA ZYDIS (OLANZAPINE) — FDA approvalDR REDDYS LABORATORIES LTD

Sponsor: CHEPLAPHARM. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →fda approvals ↗

Jan 30, 2026approval194d agoBRIVARACETAM — FDA approvalUCB SA

Sponsor: SUNSHINE. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Jan 30, 2026approval194d agoBRIVARACETAM — FDA approvalUCB SA

Sponsor: SUNSHINE. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Jan 30, 2026approval194d agoZYPREXA RELPREVV (OLANZAPINE PAMOATE) — FDA approvalCHEPLAPHARM Arzneimittel GmbH

Sponsor: CHEPLAPHARM. Form: SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR

full page →fda approvals ↗

Jan 30, 2026approval194d agoAMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM) — FDA approvalUNASYN

Sponsor: SANDOZ. Form: INJECTABLE. Route: INJECTION

full page →UNASYN →fda approvals ↗

Jan 30, 2026approval194d agoZYPREXA (OLANZAPINE) — FDA approvalTEVA PHARMACEUTICAL INDUSTRIES LTD

Sponsor: CHEPLAPHARM. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Jan 30, 2026approval194d agoARSENIC TRIOXIDE — FDA approvalQuetzal Therapeutics LLC

Sponsor: EUGIA PHARMA. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Jan 30, 2026approval194d agoEPIRUBICIN HYDROCHLORIDE — FDA approvalEPIRUBICIN HYDROCHLORIDE

Sponsor: CIPLA LTD. Form: INJECTABLE. Route: INJECTION

full page →EPIRUBICIN HYDROCHLORIDE →fda approvals ↗

Jan 30, 2026approval194d agoAMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN) — FDA approvalHikma Pharmaceuticals Plc

Sponsor: HIKMA PHARMS. Form: FOR SUSPENSION. Route: ORAL

full page →fda approvals ↗

Jan 30, 2026approval194d agoOLANZAPINE AND FLUOXETINE HYDROCHLORIDE (FLUOXETINE HYDROCHLORIDE) — FDA approvalEpic Pharma LLC

Sponsor: PH HEALTH. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Jan 30, 2026approval194d agoLIVDELZI (SELADELPAR LYSINE) — FDA approvalseladelpar lysine

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

full page →seladelpar lysine →fda approvals ↗

Jan 30, 2026approval194d agoLATANOPROST — FDA approvalXalatan

Sponsor: EPIC PHARMA LLC. Form: SOLUTION/DROPS. Route: OPHTHALMIC

full page →Xalatan →fda approvals ↗

Jan 30, 2026approval194d agoLATANOPROST — FDA approvalXalatan

Sponsor: EPIC PHARMA LLC. Form: SOLUTION/DROPS. Route: OPHTHALMIC

full page →Xalatan →fda approvals ↗

Jan 30, 2026approval194d agoLATANOPROST — FDA approvalXalatan

Sponsor: EPIC PHARMA LLC. Form: SOLUTION/DROPS. Route: OPHTHALMIC

full page →Xalatan →fda approvals ↗

Jan 30, 2026approval194d agoEMTRICITABINE, RILPIVIRINE, AND TENOFOVIR ALAFENAMIDE (EMTRICITABINE) — FDA approvalemtricitabine

Sponsor: APOTEX. Form: TABLET. Route: ORAL

full page →emtricitabine →fda approvals ↗

Jan 30, 2026approval194d agoZYPREXA (OLANZAPINE) — FDA approvalTEVA PHARMACEUTICAL INDUSTRIES LTD

Sponsor: CHEPLAPHARM. Form: POWDER. Route: INTRAMUSCULAR

full page →fda approvals ↗

Jan 30, 2026approval194d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE