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Week of Mar 2, 2026

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Mar 4, 2026recall164d agoWizcure Pharmaa Private Limited recall (Cls II)

Vista Meibo Tears Propylene Glycol 0.6% w/v Eye Drops Advanced Dry Eye Relief Revitalizing Formula, 10 ml (1/3 fl.oz.), Wizcure Pharmaa PVT. LTD., H-881, Phase 3, RIICO Industrial Area, Bhiwadi-301019, India, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ 85260, NDC 77790-003-10. — Reason: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. — Status: Ongoing

full page →fda recalls ↗

Mar 4, 2026recall164d agoAgebox recall (Cls II)Children’s Hospital of Chongqing Medical University

Agebox iKids-Growth (Day Formula) capsules, 60-count bottles, Manufactured Exclusively For: AGEBOX Inc., Wilmington, DE 19801 USA, UPC 8 50065 59701 0 — Reason: Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren — Status: Ongoing

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Mar 4, 2026recall164d agoWizcure Pharmaa Private Limited recall (Cls II)

CHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count box, NDC 83851-100-10; b) 300-count box, NDC 83851-100-30. Manufactured by Wizcure Pharmaa PVT. LTD, H-681, Phase 3, RIICO Industrial Area, Bhiwadi- 301019 INDIA, Vistamerica USA, 20 Perkins Dr. Prescott, AZ 86301, Vistamerica USA, Made in India, — Reason: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. — Status: Ongoing

full page →fda recalls ↗

Mar 4, 2026device 510k164d agoSpineCraft — ANTERIS Thoracolumbar Plate System (510k cleared)

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

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Mar 4, 2026device 510k164d agoShenzhen Kaiyan Medical Equipment Co., Ltd. — LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001) (510k cleared)

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

full page →fda device 510k ↗

Mar 4, 2026device 510k164d agoSatori Orthopaedics, Inc. — Active Intramedullary (AIM) Tibial Nail System (510k cleared)

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

full page →fda device 510k ↗

Mar 4, 2026device 510k164d agoAevumed, Inc. — Aevumed FENIX Suture Anchor (510k cleared)

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

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Mar 4, 2026device 510k164d agoDevicor Medical Products, Inc. — Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Foot Switch; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Reusable Tray; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Battery Char (510k cleared)UTAH MEDICAL PRODUCTS INC

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

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Mar 4, 2026device 510k164d agoEscala Medical, Ltd. — Mendit (510k cleared)

Product code: PBQ. Advisory committee: Obstetrics/Gynecology. Type: Special

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Mar 4, 2026device 510k164d agoLifevac, LLC — LifeVac (510k cleared)

Product code: QXN. Advisory committee: Ear, Nose, Throat. Type: Direct

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Mar 4, 2026device 510k164d agoGlobalcare Medical Technology Co., Ltd. — TENS/EMS device (GUSE01) (510k cleared)NewBay Medical Technology Co Ltd

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

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Mar 4, 2026device 510k164d agoDentis Co., Ltd. — Dentis SQ-SL AXEL Fixture (510k cleared)

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

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Mar 4, 2026device 510k164d agoDentsply Sirona, Inc. — SureSmile Software (510k cleared)DENTSPLY SIRONA Inc.

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

full page →fda device 510k ↗

Mar 4, 2026device 510k164d agoSuzhou Master Machinery Manufacturing Co.,Ltd — Electric Wheelchair (MP148) (510k cleared)

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

full page →fda device 510k ↗

Mar 4, 2026device 510k164d agoQT Imaging Holdings, Inc. — QT Scanner 2000 Model A (510k cleared)QT IMAGING HOLDINGS, INC.

Product code: IYO. Advisory committee: Radiology. Type: Special

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Mar 4, 2026device 510k164d agoRadcliffe Watts, LLC — Klär Lite (RCW-KL1000) (510k cleared)

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

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Mar 4, 2026device 510k164d agoOsstem Implant Co., Ltd. — Healing Abutment System (510k cleared)

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

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Mar 4, 2026device pma164d agoLivaNova USA, Inc. — VNS Therapy® System (PMA supplement)

Supplement type: 30-Day Notice. Product code: LYJ. Advisory committee: NE. Decision: OK30

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Mar 4, 2026device pma164d agoABBOTT MEDICAL — HeartMate 3 Left Ventricular Assist System (PMA supplement)

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

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Mar 4, 2026device pma164d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI CRT-D (DTPB2Dl, DTPB2D4, DTPB2Ql, DTPB2QQ); Cobalt XT MRI CRT-D (DTPA2Dl, DTPA2D4, DTPA2Ql, DTPA2QQ); Crome M (PMA supplement)

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

full page →fda device pma ↗

Mar 4, 2026device pma164d agoElement Science, Inc. — Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel); Jewel P-WCD Firmware; Jewel Placement Accessory (Class (PMA supplement)

Supplement type: Real-Time Process. Product code: MVK. Advisory committee: CV. Decision: APPR

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Mar 4, 2026device pma164d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI ICD (DDPB3Dl, DDPB3D4, DVPB3Dl, DVPB3D4); Cobalt XT MRI ICD (DDPA2Dl, DDPA2D4, DVPA2Dl, DVPA2D4); Crome MRI I (PMA supplement)

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

full page →fda device pma ↗

Mar 4, 2026device pma164d agoSTAAR Surgical Company — The EVO/EVO+ Visian Implantable Collamer Lens (ICL) (PMA supplement)STAAR SURGICAL CO

Supplement type: 135 Review Track For 30-Day Notice. Product code: MTA. Advisory committee: OP. Decision: APPR

full page →fda device pma ↗

Mar 4, 2026device pma164d agoLife Technologies Corporation — Oncomine Dx Target Test (PMA supplement)

Supplement type: Special (Immediate Track). Product code: PQP. Advisory committee: PA. Decision: APPR

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Mar 4, 2026device pma164d agoABBOTT MEDICAL — HeartMate 3 Left Ventricular Assist System (PMA supplement)

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

full page →fda device pma ↗

Mar 4, 2026device pma164d 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 pma164d 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 recall164d 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, 2026grant164d 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, 2026grant164d 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, 2026grant164d 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, 2026grant164d 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, 2026approval163d agoIRBESARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalPrinston Pharmaceutical Inc

Sponsor: TEVA. Form: TABLET. Route: ORAL

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Mar 5, 2026approval163d agoCHOLESTYRAMINE — FDA approvalCHOLESTYRAMINE

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

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Mar 5, 2026approval163d agoIBUPROFEN — FDA approvalMidol

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

full page →Midol →fda approvals ↗

Mar 5, 2026approval163d agoTECVAYLI (TECLISTAMAB-CQYV) — FDA approvalteclistamab

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

full page →teclistamab →fda approvals ↗

Mar 5, 2026approval163d agoTALVEY (TALQUETAMAB-TGVS) — FDA approvaltalquetamab

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

full page →talquetamab →fda approvals ↗

Mar 5, 2026approval163d agoOLANZAPINE — FDA approvalTEVA PHARMACEUTICAL INDUSTRIES LTD

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

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Mar 5, 2026approval163d agoAPREPITANT — FDA approvalAPREPITANT

Sponsor: MYLAN. Form: EMULSION. Route: INTRAVENOUS

full page →APREPITANT →fda approvals ↗

Mar 5, 2026approval163d agoCHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE HYDROCHLORIDE) — FDA approvalAlgoTherapeutix SAS

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

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Mar 5, 2026approval163d agoCHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE HYDROCHLORIDE) — FDA approvalAlgoTherapeutix SAS

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

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Mar 5, 2026approval163d agoXYZAL ALLERGY 24HR (LEVOCETIRIZINE DIHYDROCHLORIDE) — FDA approvalSanofi

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

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Mar 5, 2026approval163d agoKEFLEX (CEPHALEXIN) — FDA approvalBelcher Pharmaceuticals LLC

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

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Mar 5, 2026approval163d agoIRBESARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

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

full page →ALDACTAZIDE →fda approvals ↗

Mar 5, 2026approval163d agoERLEADA (APALUTAMIDE) — FDA approvalapalutamide

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

full page →apalutamide →fda approvals ↗

Mar 5, 2026approval163d agoPAROXETINE HYDROCHLORIDE — FDA approvalPAROXETINE HYDROCHLORIDE

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

full page →PAROXETINE HYDROCHLORIDE →fda approvals ↗

Mar 5, 2026device 510k163d 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 510k163d 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 510k163d agoNanosonics Limited — CORIS System (510k cleared)

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

full page →fda device 510k ↗

Mar 5, 2026device 510k163d agoEarlitec Diagnostics — EarliPoint Assessment (510k cleared)

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

full page →fda device 510k ↗

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