Calendar

pharmadog

Week of Mar 2, 2026

Mar 2, 2026approval165d agoMETRONIDAZOLE — FDA approvalMETRONIDAZOLE

Sponsor: INNOGENIX. Form: TABLET. Route: ORAL

full page →METRONIDAZOLE →fda approvals ↗

Mar 2, 2026approval165d agoONDANSETRON HYDROCHLORIDE — FDA approvalondansetron hydrochloride CR

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

full page →ondansetron hydrochloride CR →fda approvals ↗

Mar 2, 2026approval165d agoVENOFER (IRON SUCROSE) — FDA approvalInternational Medication Systems Ltd

Sponsor: AM REGENT. Form: INJECTABLE. Route: INTRAVENOUS

full page →fda approvals ↗

Mar 2, 2026approval165d agoIMODIUM MULTI-SYMPTOM RELIEF (LOPERAMIDE HYDROCHLORIDE) — FDA approvalBionpharma Inc

Sponsor: KENVUE BRANDS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Mar 2, 2026approval165d agoOXCARBAZEPINE — FDA approvalOXCARBAZEPINE

Sponsor: EPIC PHARMA LLC. Form: TABLET. Route: ORAL

full page →OXCARBAZEPINE →fda approvals ↗

Mar 2, 2026approval165d agoRIVAROXABAN — FDA approvalRIVAROXABAN

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

full page →RIVAROXABAN →fda approvals ↗

Mar 2, 2026approval165d agoBOSULIF (BOSUTINIB MONOHYDRATE) — FDA approvalAlembic Pharmaceuticals Inc

Sponsor: PF PRISM CV. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Mar 2, 2026approval165d agoSODIUM ACETATE — FDA approvalSODIUM ACETATE

Sponsor: AMNEAL. Form: SOLUTION. Route: INTRAVENOUS

full page →SODIUM ACETATE →fda approvals ↗

Mar 2, 2026approval165d agoMOXIFLOXACIN HYDROCHLORIDE — FDA approvalMOXIFLOXACIN HYDROCHLORIDE

Sponsor: MACLEODS PHARMS LTD. Form: TABLET. Route: ORAL

full page →MOXIFLOXACIN HYDROCHLORIDE →fda approvals ↗

Mar 2, 2026approval165d agoBOSULIF (BOSUTINIB MONOHYDRATE) — FDA approvalAlembic Pharmaceuticals Inc

Sponsor: PF PRISM CV. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Mar 2, 2026device 510k165d agoNanjing Dewen Medical Technology Co., Ltd. — Microwave Ablation Device (510k cleared)NewBay Medical Technology Co Ltd

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

full page →fda device 510k ↗

Mar 2, 2026device 510k165d agoKarl Storz SE & CO. KG — KARL STORZ Mediastinoscopes and Instruments (510k cleared)

Product code: EWY. Advisory committee: Ear, Nose, Throat. Type: Traditional

full page →fda device 510k ↗

Mar 2, 2026device 510k165d agoNanjing Devin Medical Technology Co., Ltd. — Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14, DW-XR-II5, DW-XR-II6, DW-XR-II7, DW-XR-II8, DW-XR-II9, DW-XR-II10, DW-XR-II18, DW-XR-II19, DW-XR-II20, DW-XR-II21, DW-DG-II6, DW-DG-II7, DW-DG-II9, DW-DG-II10, DW-DG-II13) (510k cleared)NewBay Medical Technology Co Ltd

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

full page →fda device 510k ↗

Mar 2, 2026device 510k165d agoClarius Mobile Health Corp. — Clarius Ejection Fraction AI (510k cleared)

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

full page →fda device 510k ↗

Mar 2, 2026device 510k165d agoMyofunctional Research Co. — Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2) (510k cleared)

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

full page →fda device 510k ↗

Mar 2, 2026device 510k165d agoGyrus Acmi, Inc. — POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) (510k cleared)

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

full page →fda device 510k ↗

Mar 2, 2026device 510k165d agoLiaoning Upcera Co., Ltd. — FLNT Base and FLNT Temp (510k cleared)

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

full page →fda device 510k ↗

Mar 2, 2026device 510k165d agoGuangzhou Heygears IMC., Inc. — UltraPrint-Dental Hard Splint UV (510k cleared)

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

full page →fda device 510k ↗

Mar 2, 2026device 510k165d agoArthrex, Inc. — Arthrex Nano FiberTak Suture Anchor (510k cleared)

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

full page →fda device 510k ↗

Mar 2, 2026device 510k165d agoSynthes GmbH — VOLT Ankle Trauma 2.7/3.5 Plating System; VOLT Calcaneus 2.7 Plating System (510k cleared)

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

full page →fda device 510k ↗

Mar 2, 2026device 510k165d agoMesi D.O.O. — MESI mTABLET SPIRO (510k cleared)

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

full page →fda device 510k ↗

Mar 2, 2026device pma165d agoABBOTT MEDICAL — HeartMate 3 Left Ventricular Assist System (LVAS) (PMA supplement)

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

full page →fda device pma ↗

Mar 2, 2026device pma165d agoAlcon Laboratories, Inc. — AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems (PMA supplement)Alcon Laboratories Inc

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

full page →fda device pma ↗

Mar 2, 2026device pma165d agoEndotronix, Inc. — Cordella Pulmonary Artery Sensor System (CorPASS) (PMA supplement)

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

full page →fda device pma ↗

Mar 2, 2026device pma165d agoAlcon Research, Ltd. — AcrySof® IQ ReSTOR Posterior Chamber Intraocular Lenses (PMA supplement)Rubicon Research Ltd

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

full page →fda device pma ↗

Mar 2, 2026device pma165d agoMicroTransponder, Inc. — Vivistim® System (PMA supplement)

Supplement type: 30-Day Notice. Product code: QPY. Advisory committee: PM. Decision: OK30

full page →fda device pma ↗

Mar 2, 2026device pma165d agoAbbott Vascular, Inc. — Perclose ProGlide Suture-Mediated Closure System; Perclose ProStyle Suture-Mediated Closure and Repair System (PMA supplement)

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

full page →fda device pma ↗

Mar 2, 2026device pma165d agoAbbott Vascular Devices — StarClose SE Vascular Closure System (PMA supplement)

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

full page →fda device pma ↗

Mar 2, 2026device pma165d agoAlcon Laboratories, LLC — Clareon® Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) and Clareon® PanOptix Hydrophobic Acrylic IOL (PMA supplement)Alcon Laboratories Inc

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

full page →fda device pma ↗

Mar 2, 2026device recall165d agoCivco Medical Instruments Co. Inc. device recall (Cls II)

eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152 — Reason: There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface. — Status: Ongoing

Week of Mar 2, 2026