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Week of Nov 10, 2025

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Nov 12, 2025device recall277d agoCardinal Health 200, LLC device recall (Cls II)CARDINAL HEALTH INC

ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full Coverage Sleeve, Universal, Medium Blue, Non-sterile; CT5502T ChemoPlus Full Coverage Gown, Closed Back, Regular/Medium, Medium Blue, Non-sterile; CT5503T ChemoPlus Full Coverage Gown, Closed Back, Large, Medium Blue, Non-sterile; CT5504T ChemoPlus Full Coverage Gown, Closed Back, Extra Large, Medium Blue, Non-sterile; CT5505T ChemoPlus Full Coverage Gown, Closed Back, Extra Extra Large, Medium Blue, Non-sterile; DP5001GT ChemoPlus Full Coverage Gown, Open Back, Large, medium Blue, Non- sterile; DP5002GT ChemoPlus Full Coverage Gown, Open Back, Extra Large, medium Blue, Non-sterile; DP5003GT ChemoPlus Full Coverage Gown, Open Back, Medium, medium Blue, Non-sterile; DP5004GT ChemoPlus Full Coverage Gown, Open Back, Extra Extra Large, medium Blue, Non-sterile; CT5500TS ChemoPlus Full Coverage Sleeve, Universal, Medium Blue, Sterile; CT5502TS ChemoPlus Full Coverage Gown, Closed Back, Regular/Medium, Medium Blue, Non-sterile; CT5503TS ChemoPlus Full Coverage Gown, Closed Back, Large, Medium Blue, Sterile; CT5504TS ChemoPlus Full Coverage Gown, Closed Back, Extra Large, Medium Blue, Sterile; CT5505TS ChemoPlus Full Coverage Gown, Closed Back, Extra Extra Large, Medium Blue, Sterile; — Reason: Affected gowns have the incorrect expiration date on the product packaging. Product has a shelf-life of three years which is mislabeled on the product packaging as five (5) years. — Status: Ongoing

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Nov 12, 2025device recall277d agoRemel, Inc device recall (Cls II)

1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT3450 — Reason: Products may contain contamination, which may result in a darker or brown media color. — Status: Ongoing

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Nov 13, 2025approval276d agoNALBUPHINE HYDROCHLORIDE — FDA approvalNALBUPHINE HYDROCHLORIDE

Sponsor: RISING. Form: SOLUTION. Route: INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

full page →NALBUPHINE HYDROCHLORIDE →fda approvals ↗

Nov 13, 2025approval276d agoATORVASTATIN CALCIUM — FDA approvalViatris Inc

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

full page →fda approvals ↗

Nov 13, 2025approval276d agoVERAPAMIL HYDROCHLORIDE — FDA approvalCalan

Sponsor: ASPIRO. Form: INJECTABLE. Route: INJECTION

full page →Calan →fda approvals ↗

Nov 13, 2025approval276d agoKOMZIFTI (ZIFTOMENIB) — FDA approvalKura Oncology, Inc.

Sponsor: KURA. Form: CAPSULE. Route: ORAL

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Nov 13, 2025approval276d agoONDANSETRON — FDA approvalSandoz Inc

Sponsor: IPCA LABS LTD. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

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Nov 13, 2025approval276d agoONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (ONDANSETRON HYDROCHLORIDE) — FDA approvalondansetron hydrochloride CR

Sponsor: ACCORD HLTHCARE. Form: INJECTABLE. Route: INJECTION

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Nov 13, 2025approval276d agoBRIVARACETAM — FDA approvalBRIVARACETAM

Sponsor: MSN. Form: TABLET. Route: ORAL

full page →BRIVARACETAM →fda approvals ↗

Nov 13, 2025approval276d agoPOHERDY (PERTUZUMAB-DPZB) — FDA approvalpertuzumab biosimilar

Sponsor: SHANGHAI HENLIUS BIOTECH. Form: INJECTABLE. Route: INTRAVENOUS

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Nov 13, 2025approval276d agoLEUPROLIDE ACETATE — FDA approvalZydus Therapeutics Inc

Sponsor: ZYDUS PHARMS. Form: SOLUTION. Route: SUBCUTANEOUS

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Nov 13, 2025approval276d agoONDANSETRON — FDA approvalSandoz Inc

Sponsor: BARR. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

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Nov 13, 2025approval276d agoRALDESY (TRAZODONE HYDROCHLORIDE) — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: KAMAT. Form: SOLUTION. Route: ORAL

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Nov 13, 2025approval276d agoIOHEXOL — FDA approvalIOHEXOL

Sponsor: AMNEAL. Form: SOLUTION. Route: INJECTION, ORAL, RECTAL

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Nov 13, 2025device 510k276d agoOrthosoft Inc. (d/b/a) Zimmer CAS — Rosa® Knee System (510k cleared)

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

full page →fda device 510k ↗

Nov 13, 2025device 510k276d agoFussen Technology Co., Ltd. — Dental Computed Tomography X-ray System (510k cleared)Viomi Technology Co., Ltd

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

full page →fda device 510k ↗

Nov 13, 2025device 510k276d agoAtop Lighting Co., Ltd. — LED Beauty Mask (RLBXX) (510k cleared)

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

full page →fda device 510k ↗

Nov 13, 2025device 510k276d agoTelltale, LLC — TELLTALE Electrosurgical Guidewire System (510k cleared)

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

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Nov 13, 2025device 510k276d agoShenzhen Future Electronic Co., Ltd. — Air Compression Therapy Device (ST-504); Air Compression Therapy Device (ST-505); Air Compression Therapy Device (ST-506); Air Compression Therapy Device (ST-507) (510k cleared)

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

full page →fda device 510k ↗

Nov 13, 2025device 510k276d agoSiemens Medical Solutions USA, Inc. — ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound System (510k cleared)

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

full page →fda device 510k ↗

Nov 13, 2025device 510k276d agoSkeletal Dynamics, Inc. — Geminus Volar Distal Radius Plating System (510k cleared)

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

full page →fda device 510k ↗

Nov 13, 2025device pma276d agoMedtronic, Inc. — Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (PMA supplement)Medtronic plc

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

full page →fda device pma ↗

Nov 13, 2025device pma276d agoMedtronic, Inc. — SynchroMed Infusion System, Ascenda Intrathecal Catheters (PMA supplement)Medtronic plc

Supplement type: Normal 180 Day Track. Product code: LKK. Advisory committee: HO. Decision: APPR

full page →fda device pma ↗

Nov 13, 2025device pma276d agoBaxter Healthcare Corp — Floseal Hemostatic Matrix, Floseal with Recothrom; Floseal Hemostatic Matrix, Floseal Fast Prep; 3 Floseal Hemostatic Ma (PMA supplement)Baxter Healthcare Corp

Supplement type: 30-Day Notice. Product code: PMX. Advisory committee: SU. Decision: OK30

full page →fda device pma ↗

Nov 13, 2025device pma276d agoMedtronic Neuromodulation — Master Restore, Itrel, Synergy, Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify (PMA supplement)

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

full page →fda device pma ↗

Nov 13, 2025device recall276d agoAbbott Laboratories device recall (Cls II)ABBOTT LABORATORIES

Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20 — Reason: Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the recall is potential performance issues found in the Alinity ci-series System software versions 3.6.1. and lower that could lead to erroneous results for multiple analytes. The issue was identified by Abbott during the internal testing of complaint investigations. — Status: Ongoing

full page →fda device recalls ↗

Nov 13, 2025device recall276d agoMicrobiologics Inc device recall (Cls II)FibroBiologics, Inc.

KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, Catalog Number 0818K — Reason: Some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10. — Status: Ongoing

full page →fda device recalls ↗

Nov 13, 2025device recall276d 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 recall276d 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 recall276d 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, 2025approval275d agoDANZITEN (NILOTINIB TARTRATE) — FDA approvalDANZITEN

Sponsor: AZURITY. Form: TABLET. Route: ORAL

full page →DANZITEN →fda approvals ↗

Nov 14, 2025approval275d agoDARZALEX FASPRO (DARATUMUMAB AND HYALURONIDASE-FIHJ) — FDA approval(daratumumab + hyaluronidase (human recombinant))

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

full page →(daratumumab + hyaluronidase (human recombinant)) →fda approvals ↗

Nov 14, 2025approval275d agoALDACTAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

Sponsor: PFIZER. Form: TABLET. Route: ORAL

full page →ALDACTAZIDE →fda approvals ↗

Nov 14, 2025approval275d agoLUPRON DEPOT-PED KIT (LEUPROLIDE ACETATE) — FDA approvalAmneal Pharmaceuticals, Inc.

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

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Nov 14, 2025approval275d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

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

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Nov 14, 2025approval275d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

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

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Nov 14, 2025approval275d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

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

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Nov 14, 2025approval275d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

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

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Nov 14, 2025approval275d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

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

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Nov 14, 2025approval275d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

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

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Nov 14, 2025approval275d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

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

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Nov 14, 2025approval275d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

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

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Nov 14, 2025approval275d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

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

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Nov 14, 2025approval275d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

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

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Nov 14, 2025approval275d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

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

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Nov 14, 2025approval275d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

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

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Nov 14, 2025approval275d agoDIAZEPAM — FDA approvalDIAZEPAM

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

full page →DIAZEPAM →fda approvals ↗

Nov 14, 2025approval275d agoLENALIDOMIDE — FDA approvalLENALIDOMIDE

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

full page →LENALIDOMIDE →fda approvals ↗

Nov 14, 2025approval275d agoDIPHENHYDRAMINE HYDROCHLORIDE — FDA approvalPAI Holding Co LLC

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

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Nov 14, 2025approval275d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

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

full page →fda approvals ↗

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