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Week of Oct 20, 2025

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Oct 23, 2025device 510k296d agoAlign Technology, Inc. — Invisalign® Palatal Expander System (510k cleared)ALIGN TECHNOLOGY INC

Product code: NXC. Advisory committee: Dental. Type: Special

full page →fda device 510k ↗

Oct 23, 2025device 510k296d agoAsclepion Laser Technologies GmbH — MultiPulse TFL (510k cleared)

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

full page →fda device 510k ↗

Oct 23, 2025device 510k296d agoHartalega NGC Sdn. Bhd. — Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black) (510k cleared)Teva Pharmaceuticals USA Inc

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

full page →fda device 510k ↗

Oct 23, 2025device 510k296d agoSa3, LLC — Silatrix Oral Gel (510k cleared)

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

full page →fda device 510k ↗

Oct 23, 2025device 510k296d agoRisu Medical Technology Co., Ltd. — Picosecond Laser Device (PF131-BI) (510k cleared)NewBay Medical Technology Co Ltd

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

full page →fda device 510k ↗

Oct 23, 2025device 510k296d agoTerrats Medical SL — DESS® Dental Smart Solutions (510k cleared)

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

full page →fda device 510k ↗

Oct 23, 2025device 510k296d agoZhengzhou PZ Laser Slim Technology Co., Ltd. — 1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02) (510k cleared)

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

full page →fda device 510k ↗

Oct 23, 2025device 510k296d agoUroviu Corporation — UV5000W Handle (510k cleared)

Product code: FAJ. Advisory committee: Gastroenterology, Urology. Type: Special

full page →fda device 510k ↗

Oct 23, 2025device 510k296d agoTerarecon,Inc. — TeraRecon Cardiovascular.Calcification.CT (510k cleared)

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

full page →fda device 510k ↗

Oct 23, 2025device pma296d agoABBOTT MEDICAL — Amplatzer Muscular VSD Occluder (PMA supplement)

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

full page →fda device pma ↗

Oct 23, 2025device pma296d agoBoston Scientific Corporation — ENROUTE® Transcarotid Stent System (PMA supplement)BOSTON SCIENTIFIC CORP

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

full page →fda device pma ↗

Oct 23, 2025device pma296d agoABBOTT MEDICAL — Amplatzer Duct Occluder; Amplatzer Duct Occluder II; Amplatzer Piccolo Occluder (PMA supplement)

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

full page →fda device pma ↗

Oct 23, 2025device pma296d agoMedtronic, Inc. — Mosaic Bioprosthesis, Models 305, 310 (PMA supplement)Medtronic plc

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

full page →fda device pma ↗

Oct 23, 2025device pma296d agoABBOTT MEDICAL — Amplatzer Amulet Left Atrial Appendage Occluder (PMA supplement)

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

full page →fda device pma ↗

Oct 23, 2025device pma296d agoMedtronic, Inc. — Freestyle Bioprosthesis, Models 995, 995CS, 995MS (PMA supplement)Medtronic plc

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

full page →fda device pma ↗

Oct 23, 2025device pma296d agoMedtronic Vascular — Endurant II/IIs Stent Graft System (PMA supplement)

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

full page →fda device pma ↗

Oct 23, 2025device pma296d agoMedtronic, Inc. — Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (PMA supplement)Medtronic plc

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

full page →fda device pma ↗

Oct 23, 2025device pma296d agoMedtronic, Inc. — Avalus Bioprosthesis, Model 400 (PMA supplement)Medtronic plc

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

full page →fda device pma ↗

Oct 23, 2025device pma296d agoMedtronic Neuromodulation — Master Restore, Itrel, Synergy, Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces-Quad, Spe (PMA supplement)

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

full page →fda device pma ↗

Oct 23, 2025device pma296d agoBiotronik Nro, Inc. — Prospera SCS System; Resilience Percutaneous Lead; Embrace One; TrueLock (PMA supplement)

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

full page →fda device pma ↗

Oct 23, 2025device pma296d agoMedtronic, Inc. — Melody Transcatheter Pulmonary Valve (PMA supplement)Medtronic plc

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

full page →fda device pma ↗

Oct 23, 2025device pma296d agoABBOTT MEDICAL — Amplatzer Septal Occluder; Amplatzer Multi-Fenestrated Septal Occluder - Cribriform (PMA supplement)

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

full page →fda device pma ↗

Oct 23, 2025device pma296d agoABBOTT MEDICAL — Amplatzer PFO Occluder; Amplatzer Talisman PFO Occluder (PMA supplement)

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

full page →fda device pma ↗

Oct 23, 2025device pma296d agoMedtronic, Inc. — Hancock II Bioprosthesis, Models T505, T510 (PMA supplement)Medtronic plc

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

full page →fda device pma ↗

Oct 23, 2025device pma296d agoNovocure, GmbH — Optune Gio - Maxpoint Version 2.0 (PMA supplement)NovoCure Ltd

Supplement type: Normal 180 Day Track. Product code: NZK. Advisory committee: NE. Decision: APPR

full page →fda device pma ↗

Oct 23, 2025device pma296d agoMedtronic, Inc. — Harmony Transcatheter Pulmonary Valve (PMA supplement)Medtronic plc

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

full page →fda device pma ↗

Oct 23, 2025device recall296d agoDatascope Corp. device recall (Cls III)

Cardiosave Rescue — Reason: The IFU addendum updates the Vibration and Shock Table to reference the correct standards. — Status: Ongoing

full page →fda device recalls ↗

Oct 23, 2025device recall296d agoDatascope Corp. device recall (Cls III)

Cardiosave Hybrid — Reason: The IFU addendum updates the Vibration and Shock Table to reference the correct standards. — Status: Ongoing

full page →fda device recalls ↗

Oct 23, 2025device recall296d agoBecton Dickinson & Co. device recall (Cls II)BECTON DICKINSON & CO

BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100; — Reason: The 2D barcodes on these cuvettes contain formatting errors that prevent the analyzing system from correctly reading the expiration date. As a result, the instrument enters an error state and the cuvettes cannot be used. — Status: Ongoing

full page →fda device recalls ↗

Oct 24, 2025approval295d agoNEFFY (EPINEPHRINE) — FDA approvalInternational Medication Systems Ltd

Sponsor: ARS PHARMS OPERATION. Form: SPRAY. Route: NASAL

full page →fda approvals ↗

Oct 24, 2025approval295d agoWINREVAIR (SOTATERCEPT-CSRK) — FDA approvalsotatercept

Sponsor: MERCK SHARP DOHME. Form: INJECTABLE. Route: INJECTION

full page →sotatercept →fda approvals ↗

Oct 24, 2025approval295d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

Sponsor: SUN PHARM INDUSTRIES. Form: TABLET. Route: ORAL

full page →tramadol hydrochloride ER →fda approvals ↗

Oct 24, 2025approval295d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: CHARTWELL. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Oct 24, 2025approval295d agoTRAMADOL HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: AMNEAL PHARMS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Oct 24, 2025approval295d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: CHARTWELL. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Oct 24, 2025approval295d agoATROPINE SULFATE — FDA approvalATROPINE SULFATE

Sponsor: HIKMA. Form: SOLUTION. Route: INTRAVENOUS

full page →ATROPINE SULFATE →fda approvals ↗

Oct 24, 2025approval295d agoLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

Sponsor: LUPIN LTD. Form: TABLET. Route: ORAL

full page →ALDACTAZIDE →fda approvals ↗

Oct 24, 2025approval295d agoANASTROZOLE — FDA approvalStason Pharmaceuticals Inc

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

full page →fda approvals ↗

Oct 24, 2025approval295d agoLEFLUNOMIDE — FDA approvalLEFLUNOMIDE

Sponsor: HERITAGE. Form: TABLET. Route: ORAL

full page →LEFLUNOMIDE →fda approvals ↗

Oct 24, 2025approval295d agoSYNJARDY XR (EMPAGLIFLOZIN) — FDA approval(empagliflozin + metformin hydrochloride ER)

Sponsor: BOEHRINGER INGELHEIM. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →(empagliflozin + metformin hydrochloride ER) →fda approvals ↗

Oct 24, 2025approval295d agoLYNKUET (ELINZANETANT) — FDA approvalBayer USA LLC

Sponsor: BAYER HLTHCARE. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Oct 24, 2025approval295d agoREVUFORJ (REVUMENIB CITRATE) — FDA approvalrevumenib citrate

Sponsor: SYNDAX. Form: TABLET. Route: ORAL

full page →revumenib citrate →fda approvals ↗

Oct 24, 2025approval295d agoCOPIKTRA (DUVELISIB) — FDA approvalSecura Bio Inc

Sponsor: SECURA. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Oct 24, 2025approval295d agoGLYXAMBI (EMPAGLIFLOZIN) — FDA approval(empagliflozin + linagliptin)

Sponsor: BOEHRINGER INGELHEIM. Form: TABLET. Route: ORAL

full page →(empagliflozin + linagliptin) →fda approvals ↗

Oct 24, 2025approval295d agoLETROZOLE — FDA approvalHikma Pharmaceuticals Plc

Sponsor: HIKMA PHARMS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Oct 24, 2025approval295d agoANASTROZOLE — FDA approvalANASTROZOLE

Sponsor: SANDOZ. Form: TABLET. Route: ORAL

full page →ANASTROZOLE →fda approvals ↗

Oct 24, 2025approval295d agoSYNJARDY (EMPAGLIFLOZIN) — FDA approvalSYNJARDY

Sponsor: BOEHRINGER INGELHEIM. Form: TABLET. Route: ORAL

full page →SYNJARDY →fda approvals ↗

Oct 24, 2025approval295d agoTRIJARDY XR (EMPAGLIFLOZIN) — FDA approval(empagliflozin + linagliptin + metformin hydrochloride) ER

Sponsor: BOEHRINGER INGELHEIM. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →(empagliflozin + linagliptin + metformin hydrochloride) ER →fda approvals ↗

Oct 24, 2025approval295d agoROCURONIUM BROMIDE — FDA approvalROCURONIUM BROMIDE

Sponsor: B BRAUN MEDICAL. Form: SOLUTION. Route: INTRAVENOUS

full page →ROCURONIUM BROMIDE →fda approvals ↗

Oct 24, 2025approval295d agoJARDIANCE (EMPAGLIFLOZIN) — FDA approvalSYNJARDY

Sponsor: BOEHRINGER INGELHEIM. Form: TABLET. Route: ORAL

full page →SYNJARDY →fda approvals ↗

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