Calendar

Week of Mar 2, 2026

Mar 4, 2026device pma168d agoABBOTT MEDICAL — HeartMate 3 Left Ventricular Assist System (PMA supplement)

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

Mar 4, 2026device pma168d agoCooperVision, Inc. — Biofinity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (PMA supplement)

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

full page →fda device pma ↗

Mar 4, 2026device pma168d agoCooperVision, Inc. — Biofinity Toric Multifocal (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (PMA supplement)

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

full page →fda device pma ↗

Mar 4, 2026device recall168d agoKoven Technology, Inc. device recall (Cls II)WM TECHNOLOGY, INC.

Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Model/Catalog Number: ES-100V3 (device); BT2M20S8C (2 MHz fetal probe). Software Version: N/A Product Description: Hand-held, battery-powered ultrasonic Doppler blood-flow detector with LCD numeric display, used with interchangeable probes to detect vascular blood-flow signals and display heart rate; affected units were packaged with a 2 MHz BT2M20S8C fetal probe and labeled for both vascular and fetal applications. — Reason: Product labeling includes a fetal indication for use that is not cleared under its 510(k). — Status: Ongoing

full page →fda device recalls ↗

Mar 4, 2026grant168d agoGORDON RESEARCH CONFERENCES — 2026 Single-Cell Cancer Biology Gordon Research Conference and Gordon Researc...

CA grant. $10,000. PI: Ken Chen

full page →nih reporter ↗

Mar 4, 2026grant168d agoALBERT EINSTEIN COLLEGE OF MEDICINE — Scalable imaging approach to measure muscle bioenergetics in CKD.Albert Einstein College of Medicine

AR grant. $556,651. PI: Matthew K Abramowitz

full page →nih reporter ↗

Mar 4, 2026grant168d agoUNIVERSITY OF ALABAMA AT BIRMINGHAM — 10-Year Follow-Up of the Medical Optimization and Management of Pregnancies w...

DK grant. $1,934,914. PI: Ashley Nicole Battarbee

full page →nih reporter ↗

Mar 4, 2026grant168d agoUNIVERSITY OF MICHIGAN AT ANN ARBOR — Neocortical-hippocampal coordination and plasticity in sleep-dependent memory...

NS grant. $419,920. PI: SARA J ATON

full page →nih reporter ↗

Mar 5, 2026approval167d agoIRBESARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalPrinston Pharmaceutical Inc

Sponsor: TEVA. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Mar 5, 2026approval167d agoCHOLESTYRAMINE — FDA approvalCHOLESTYRAMINE

Sponsor: MICRO LABS. Form: POWDER. Route: ORAL

full page →CHOLESTYRAMINE →fda approvals ↗

Mar 5, 2026approval167d agoIBUPROFEN — FDA approvalMidol

Sponsor: RUBICON RESEARCH. Form: SUSPENSION. Route: ORAL

full page →Midol →fda approvals ↗

Mar 5, 2026approval167d agoTECVAYLI (TECLISTAMAB-CQYV) — FDA approvalteclistamab

Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION

full page →teclistamab →fda approvals ↗

Mar 5, 2026approval167d agoTALVEY (TALQUETAMAB-TGVS) — FDA approvaltalquetamab

Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION

full page →talquetamab →fda approvals ↗

Mar 5, 2026approval167d agoOLANZAPINE — FDA approvalTEVA PHARMACEUTICAL INDUSTRIES LTD

Sponsor: ANTHEA PHARMA. Form: POWDER. Route: INTRAMUSCULAR

full page →fda approvals ↗

Mar 5, 2026approval167d agoAPREPITANT — FDA approvalAPREPITANT

Sponsor: MYLAN. Form: EMULSION. Route: INTRAVENOUS

full page →APREPITANT →fda approvals ↗

Mar 5, 2026approval167d agoCHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE HYDROCHLORIDE) — FDA approvalAlgoTherapeutix SAS

Sponsor: TP ANDA HOLDINGS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Mar 5, 2026approval167d agoCHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE HYDROCHLORIDE) — FDA approvalAlgoTherapeutix SAS

Sponsor: TP ANDA HOLDINGS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Mar 5, 2026approval167d agoXYZAL ALLERGY 24HR (LEVOCETIRIZINE DIHYDROCHLORIDE) — FDA approvalSanofi

Sponsor: CHATTEM SANOFI. Form: SOLUTION. Route: ORAL

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Mar 5, 2026approval167d agoKEFLEX (CEPHALEXIN) — FDA approvalBelcher Pharmaceuticals LLC

Sponsor: PRAGMA. Form: FOR SUSPENSION. Route: ORAL

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Mar 5, 2026approval167d agoIRBESARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

Sponsor: PRINSTON INC. Form: TABLET. Route: ORAL

full page →ALDACTAZIDE →fda approvals ↗

Mar 5, 2026approval167d agoERLEADA (APALUTAMIDE) — FDA approvalapalutamide

Sponsor: JANSSEN BIOTECH. Form: TABLET. Route: ORAL

full page →apalutamide →fda approvals ↗

Mar 5, 2026approval167d agoPAROXETINE HYDROCHLORIDE — FDA approvalPAROXETINE HYDROCHLORIDE

Sponsor: ANNORA PHARMA. Form: SUSPENSION. Route: ORAL

full page →PAROXETINE HYDROCHLORIDE →fda approvals ↗

Mar 5, 2026device 510k167d agoZhuhai DR Medical Instruments Co., Ltd. — Extension tube (510k cleared)

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

full page →fda device 510k ↗

Mar 5, 2026device 510k167d agoParagon 28, Inc. — Phantom® Hindfoot TTC/TC Nail System (510k cleared)

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

full page →fda device 510k ↗

Mar 5, 2026device 510k167d agoNanosonics Limited — CORIS System (510k cleared)

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

full page →fda device 510k ↗

Mar 5, 2026device 510k167d agoEarlitec Diagnostics — EarliPoint Assessment (510k cleared)

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

full page →fda device 510k ↗

Mar 5, 2026device 510k167d agoIvoclar Vivadent, Inc. — Adhese 2 (510k cleared)

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

full page →fda device 510k ↗

Mar 5, 2026device 510k167d agoArthrex, Inc. — Arthrex FibuLock Nail System (510k cleared)

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

full page →fda device 510k ↗

Mar 5, 2026device 510k167d agoPhilips Medical Systems Nederland B.V. — AV Cardiac CT (510k cleared)

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

full page →fda device 510k ↗

Mar 5, 2026device 510k167d agoOrca Dental AI , Ltd. — CEPHX3D (510k cleared)

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

full page →fda device 510k ↗

Mar 5, 2026device 510k167d agoJiangsu Yuyue Medical Equipment & Supply Co., Ltd. — YUWELL® Electronic Blood Pressure Monitor (YE630CR) (510k cleared)

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

full page →fda device 510k ↗

Mar 5, 2026device 510k167d agoEsaote, S.p.A. — Magnifico Open (100009900) (510k cleared)

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

full page →fda device 510k ↗

Mar 5, 2026device pma167d agoBiotronik, Inc. — Acticor Sky VR-T (481989); Rivacor Sky VR-T (481984); Rivacor Rise VR-T (482020); Rivacor Aura VR-T (482015); Acticor Sk (PMA supplement)

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

full page →fda device pma ↗

Mar 5, 2026device pma167d agoShockwave Medical, Inc. — Shockwave lntravascular Lithotripsy (IVL) System with Shockwave C2 Aero Coronary IVL Catheter (PMA supplement)

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

full page →fda device pma ↗

Mar 5, 2026device pma167d agoBoston Scientific Corp — ROTAPRO Rotational Atherectomy System (PMA supplement)BOSTON SCIENTIFIC CORP

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

full page →fda device pma ↗

Mar 5, 2026device pma167d agoBiotronik, Inc. — Edora 8 DR-T (407145); Evity 8 DR-T (407146); Enitra 8 DR-T (407147); Enticos 8 DR-T (407148); Evity 6 DR-T (407149); En (PMA supplement)

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

full page →fda device pma ↗

Mar 5, 2026device pma167d agoInsightec — Exablate Model 4000 Type 1.0 and 1.1 (Exablate Neuro; Exablate Prime) (PMA supplement)

Supplement type: Real-Time Process. Product code: POH. Advisory committee: NE. Decision: APPR

full page →fda device pma ↗

Mar 5, 2026device pma167d agoBiotronik, Inc. — Acticor 7 VR-T (429526); Rivacor 7 VR-T (429536); Rivacor 5 VR-T (429565); Rivacor 3 VR-T (429574); Acticor 7 VR-T DX (4 (PMA supplement)

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

full page →fda device pma ↗

Mar 5, 2026device pma167d agoBiotronik, Inc. — Edora 8 HF-T QP (407137); Edora 8 HF-T (407138); Evity 8 HF-T QP (407139); Evity 8 HF-T (407140); Enitra 8 HF-T QP (4071 (PMA supplement)

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

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Mar 5, 2026device pma167d agoHologic, Inc. — Rapid fFN for the TLiIQ System (PMA supplement)

Supplement type: 30-Day Notice. Product code: LKV. Advisory committee: TX. Decision: OK30

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Mar 5, 2026device pma167d agoHologic, Inc. — Rapid fFN for the TLiIQ System (PMA supplement)

Supplement type: 30-Day Notice. Product code: LKV. Advisory committee: TX. Decision: OK30

full page →fda device pma ↗

Mar 5, 2026device pma167d agoPhysio-Control, Inc. — LIFEPAK 35 monitor/defibrillator (PMA supplement)

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

full page →fda device pma ↗