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Week of Nov 10, 2025

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Nov 13, 2025device recall278d agoMedtronic MiniMed, Inc. device recall (Cls II)Medtronic USA Inc

InPen App, Model/CFN Number: MMT-8061 (Android Users) — Reason: When app is uninstalled and reinstalled, insulin pen software issue causes Choose Notification Style Screen to not show during setup so users can't choose to allow notifications to override phone settings when on mute/Do Not Disturb, and previously set up override permission is deleted, so audible and vibratory notifications not received, which may lead to delayed insulin therapy, hyperglycemia. — Status: Ongoing

full page →fda device recalls ↗

Nov 13, 2025device recall278d agoMedline Industries, LP device recall (Cls II)

SCISSORS, OR, SHARP/BLUNT, 5.5", STERILE, Item Number DYND04000 — Reason: The items may have weak packaging seals that may result in a breach of sterility if the seal fails and may lead to an increased risk of infection if product is utilized. — Status: Ongoing

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Nov 13, 2025device recall278d agoMedline Industries, LP device recall (Cls II)

FORCEP, STD STR, STERILE KELLY, 5.5 IN, Item Number DYNJ04048 — Reason: The items may have weak packaging seals that may result in a breach of sterility if the seal fails and may lead to an increased risk of infection if product is utilized. — Status: Ongoing

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Nov 14, 2025approval277d agoDANZITEN (NILOTINIB TARTRATE) — FDA approvalDANZITEN

Sponsor: AZURITY. Form: TABLET. Route: ORAL

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Nov 14, 2025approval277d agoDARZALEX FASPRO (DARATUMUMAB AND HYALURONIDASE-FIHJ) — FDA approval(daratumumab + hyaluronidase (human recombinant))

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

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Nov 14, 2025approval277d agoALDACTAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

Sponsor: PFIZER. Form: TABLET. Route: ORAL

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Nov 14, 2025approval277d agoLUPRON DEPOT-PED KIT (LEUPROLIDE ACETATE) — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: ABBVIE ENDOCRINE INC. Form: POWDER. Route: INTRAMUSCULAR

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Nov 14, 2025approval277d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: TEVA PHARMS USA. Form: TABLET. Route: ORAL

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Nov 14, 2025approval277d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: TEVA PHARMS USA. Form: TABLET. Route: ORAL

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Nov 14, 2025approval277d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: TEVA PHARMS USA. Form: TABLET. Route: ORAL

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Nov 14, 2025approval277d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: TEVA PHARMS USA. Form: TABLET. Route: ORAL

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Nov 14, 2025approval277d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: TEVA PHARMS USA. Form: TABLET. Route: ORAL

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Nov 14, 2025approval277d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: TEVA PHARMS USA. Form: TABLET. Route: ORAL

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Nov 14, 2025approval277d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: TEVA PHARMS USA. Form: TABLET. Route: ORAL

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Nov 14, 2025approval277d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: TEVA PHARMS USA. Form: TABLET. Route: ORAL

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Nov 14, 2025approval277d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: TEVA PHARMS USA. Form: TABLET. Route: ORAL

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Nov 14, 2025approval277d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: TEVA PHARMS USA. Form: TABLET. Route: ORAL

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Nov 14, 2025approval277d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: TEVA PHARMS USA. Form: TABLET. Route: ORAL

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Nov 14, 2025approval277d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: TEVA PHARMS USA. Form: TABLET. Route: ORAL

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Nov 14, 2025approval277d agoDIAZEPAM — FDA approvalDIAZEPAM

Sponsor: NAVINTA LLC. Form: GEL. Route: RECTAL

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Nov 14, 2025approval277d agoLENALIDOMIDE — FDA approvalLENALIDOMIDE

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

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Nov 14, 2025approval277d agoDIPHENHYDRAMINE HYDROCHLORIDE — FDA approvalPAI Holding Co LLC

Sponsor: AVET LIFESCIENCES. Form: INJECTABLE. Route: INJECTION

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Nov 14, 2025approval277d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: TEVA PHARMS USA. Form: TABLET. Route: ORAL

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Nov 14, 2025approval277d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: TEVA PHARMS USA. Form: TABLET. Route: ORAL

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Nov 14, 2025approval277d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: TEVA PHARMS USA. Form: TABLET. Route: ORAL

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Nov 14, 2025approval277d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: TEVA PHARMS USA. Form: TABLET. Route: ORAL

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Nov 14, 2025approval277d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: TEVA PHARMS USA. Form: TABLET. Route: ORAL

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Nov 14, 2025approval277d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: TEVA PHARMS USA. Form: TABLET. Route: ORAL

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Nov 14, 2025approval277d agoFOSFOMYCIN TROMETHAMINE — FDA approvalFOSFOMYCIN TROMETHAMINE

Sponsor: AUROBINDO PHARMA LTD. Form: FOR SOLUTION. Route: ORAL

full page →FOSFOMYCIN TROMETHAMINE →fda approvals ↗

Nov 14, 2025approval277d agoALDACTONE (SPIRONOLACTONE) — FDA approvalALDACTONE

Sponsor: PFIZER. Form: TABLET. Route: ORAL

full page →ALDACTONE →fda approvals ↗

Nov 14, 2025approval277d agoDILTIAZEM HYDROCHLORIDE — FDA approvalDILTIAZEM HYDROCHLORIDE

Sponsor: ALEMBIC. Form: TABLET. Route: ORAL

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Nov 14, 2025approval277d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

Sponsor: ASCENT PHARMS INC. Form: TABLET. Route: ORAL

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Nov 14, 2025approval277d agoVORICONAZOLE — FDA approvalVORICONAZOLE

Sponsor: HAINAN POLY PHARM. Form: SOLUTION. Route: INTRAVENOUS

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Nov 14, 2025approval277d agoRIVAROXABAN — FDA approvalRIVAROXABAN

Sponsor: APOTEX. Form: TABLET. Route: ORAL

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Nov 14, 2025approval277d agoTRUQAP (CAPIVASERTIB) — FDA approvalcapivasertib

Sponsor: ASTRAZENECA. Form: TABLET. Route: ORAL

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Nov 14, 2025device 510k277d agoPrinceton BioMeditech Corp. — Status COVID-19/Flu A&B (510k cleared)

Product code: SCA. Advisory committee: Microbiology. Type: Dual Track

full page →fda device 510k ↗

Nov 14, 2025device 510k277d agoParagon Implant Mfg., LLC — Sterilization Trays (510k cleared)

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

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Nov 14, 2025device 510k277d agoThis AG — System Sophi (510k cleared)

Product code: HQC. Advisory committee: Ophthalmic. Type: Traditional

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Nov 14, 2025device 510k277d agoKLS-Martin L.P. — KLS Martin IPS Forearm System (510k cleared)

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

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Nov 14, 2025device 510k277d agoFresenius Medical Care Renal Therapies Group, LLC — AquaC UNO H (510k cleared)Fresenius Medical Care AG

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

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Nov 14, 2025device 510k277d agoOnward Medical, Inc. — ARC-EX System (510k cleared)Picard Medical, Inc.

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

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Nov 14, 2025device 510k277d agoQingdao Future Medical Technology Co., Ltd. — Mesh Nebulizer (H6) (510k cleared)

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

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Nov 14, 2025device 510k277d agoEos Imaging — AutoDensity (510k cleared)

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

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Nov 14, 2025device 510k277d agoBiomoneta Research Private Limited — Biomoneta Avata Rx (510k cleared)

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

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Nov 14, 2025device 510k277d agoFusmobile, Inc. — Neurolyser XR (NXR100) (510k cleared)

Product code: SGN. Advisory committee: Neurology. Type: Direct

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Nov 14, 2025device 510k277d agoPearl, Inc. — Second Opinion® Panoramic (510k cleared)

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

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Nov 14, 2025device 510k277d agoInanovate, Inc. — Lyme-ID IgG Test; Bio-ID800 (510k cleared)

Product code: LSR. Advisory committee: Microbiology. Type: Traditional

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Nov 14, 2025device 510k277d agoAlovea Healthcare Co. , Ltd. — IPL Hair Removal Device (I6 S1, I6 D1, I6 M1) (510k cleared)NVP Healthcare Co Ltd

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

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Nov 14, 2025device pma277d agoAtriCure, Inc. — EPi-Sense ST Coagulation System (PMA supplement)AtriCure, Inc.

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

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Nov 14, 2025device pma277d agoSTAAR Surgical Company — VISIAN ICL (IMPLANTABLE COLLAMER LENS) (PMA supplement)STAAR SURGICAL CO

Supplement type: Normal 180 Day Track. Product code: MTA. Advisory committee: OP. Decision: APPR

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