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Week of Sep 29, 2025

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Sep 30, 2025approval334d agoRHAPSIDO (REMIBRUTINIB) — FDA approvalremibrutinib

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →remibrutinib →fda approvals ↗

Sep 30, 2025approval334d agoMIFEPRISTONE — FDA approvalMIFEPRISTONE

Sponsor: EVITA SOLUTIONS. Form: TABLET. Route: ORAL

full page →MIFEPRISTONE →fda approvals ↗

Sep 30, 2025approval334d agoTIZANIDINE HYDROCHLORIDE — FDA approvalRiconpharma LLC

Sponsor: ALKEM LABS LTD. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Sep 30, 2025approval334d agoVORICONAZOLE — FDA approvalVORICONAZOLE

Sponsor: MEITHEAL. Form: POWDER. Route: INTRAVENOUS

full page →VORICONAZOLE →fda approvals ↗

Sep 30, 2025approval334d agoCIPROFLOXACIN HYDROCHLORIDE — FDA approvalCIPROFLOXACIN HYDROCHLORIDE

Sponsor: CHARTWELL. Form: TABLET. Route: ORAL

full page →CIPROFLOXACIN HYDROCHLORIDE →fda approvals ↗

Sep 30, 2025approval334d agoCIPROFLOXACIN HYDROCHLORIDE — FDA approvalCIPROFLOXACIN HYDROCHLORIDE

Sponsor: CHARTWELL. Form: TABLET. Route: ORAL

full page →CIPROFLOXACIN HYDROCHLORIDE →fda approvals ↗

Sep 30, 2025approval334d agoCIPROFLOXACIN HYDROCHLORIDE — FDA approvalCIPROFLOXACIN HYDROCHLORIDE

Sponsor: CHARTWELL. Form: TABLET. Route: ORAL

full page →CIPROFLOXACIN HYDROCHLORIDE →fda approvals ↗

Sep 30, 2025approval334d agoCIPROFLOXACIN HYDROCHLORIDE — FDA approvalCIPROFLOXACIN HYDROCHLORIDE

Sponsor: CHARTWELL. Form: TABLET. Route: ORAL

full page →CIPROFLOXACIN HYDROCHLORIDE →fda approvals ↗

Sep 30, 2025approval334d agoCIPROFLOXACIN HYDROCHLORIDE — FDA approvalCIPROFLOXACIN HYDROCHLORIDE

Sponsor: CHARTWELL. Form: TABLET. Route: ORAL

full page →CIPROFLOXACIN HYDROCHLORIDE →fda approvals ↗

Sep 30, 2025approval334d agoCIPROFLOXACIN HYDROCHLORIDE — FDA approvalCIPROFLOXACIN HYDROCHLORIDE

Sponsor: CHARTWELL. Form: TABLET. Route: ORAL

full page →CIPROFLOXACIN HYDROCHLORIDE →fda approvals ↗

Sep 30, 2025approval334d agoCIPROFLOXACIN HYDROCHLORIDE — FDA approvalCIPROFLOXACIN HYDROCHLORIDE

Sponsor: CHARTWELL. Form: TABLET. Route: ORAL

full page →CIPROFLOXACIN HYDROCHLORIDE →fda approvals ↗

Sep 30, 2025approval334d agoCIPROFLOXACIN HYDROCHLORIDE — FDA approvalCIPROFLOXACIN HYDROCHLORIDE

Sponsor: CHARTWELL. Form: TABLET. Route: ORAL

full page →CIPROFLOXACIN HYDROCHLORIDE →fda approvals ↗

Sep 30, 2025approval334d agoLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

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

full page →ALDACTAZIDE →fda approvals ↗

Sep 30, 2025approval334d agoPEPCID COMPLETE (CALCIUM CARBONATE) — FDA approvalKenvue Inc.

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

full page →fda approvals ↗

Sep 30, 2025approval334d agoDASATINIB — FDA approvalXspray Pharma AB

Sponsor: DR REDDYS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Sep 30, 2025approval334d agoLEVONORGESTREL — FDA approvalPostinor

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

full page →Postinor →fda approvals ↗

Sep 30, 2025approval334d agoMONTELUKAST SODIUM — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

Sep 30, 2025approval334d agoMONTELUKAST SODIUM — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

Sep 30, 2025approval334d agoMONTELUKAST SODIUM — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

Sep 30, 2025approval334d agoOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

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

full page →ALDACTAZIDE →fda approvals ↗

Sep 30, 2025approval334d agoZIPRASIDONE HYDROCHLORIDE — FDA approvalLupin Ltd

Sponsor: LUPIN PHARMS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Sep 30, 2025approval334d agoLUPRON (LEUPROLIDE ACETATE) — FDA approvalInvaGen Pharmaceuticals Inc

Sponsor: ABBVIE ENDOCRINE INC. Form: SOLUTION. Route: SUBCUTANEOUS

full page →fda approvals ↗

Sep 30, 2025approval334d agoTAMSULOSIN HYDROCHLORIDE — FDA approvalSynthon Pharmaceuticals Inc (Inactive)

Sponsor: PHARMOBEDIENT. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Sep 30, 2025approval334d agoROPINIROLE HYDROCHLORIDE — FDA approvalropinirole hydrochloride ER

Sponsor: ZYDUS LIFESCIENCES. Form: TABLET. Route: ORAL

full page →ropinirole hydrochloride ER →fda approvals ↗

Sep 30, 2025approval334d agoTEGRETOL (CARBAMAZEPINE) — FDA approvalcarbamazepine ER

Sponsor: NOVARTIS. Form: SUSPENSION. Route: ORAL

full page →carbamazepine ER →fda approvals ↗

Sep 30, 2025approval334d agoNEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (HYDROCORTISONE) — FDA approvalET-800

Sponsor: AMNEAL. Form: SUSPENSION/DROPS. Route: OTIC

full page →ET-800 →fda approvals ↗

Sep 30, 2025approval334d agoTOFACITINIB CITRATE — FDA approvaltofacitinib citrate ER

Sponsor: SINOTHERAPEUTICS INC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →tofacitinib citrate ER →fda approvals ↗

Sep 30, 2025device 510k334d agoJiangsu Bangbang Intelligent Technology Co., Ltd. — Mobility Scooter (BBR-Q40-01); Mobility Scooter (BBR-Q40-02); Mobility Scooter (BBR-Q40-03); Mobility Scooter (BBR-Q40-04); Mobility Scooter (BBR-Q40-05); Mobility Scooter (BBR-Q40-06) (510k cleared)

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

full page →fda device 510k ↗

Sep 30, 2025device 510k334d agoMidiagnostics NV — miDiagnostics HSV-1&2 CSF Test (510k cleared)

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

full page →fda device 510k ↗

Sep 30, 2025device 510k334d agoAstrasono Technology Co., Ltd. — Astrasono A3Pro Bladder Scanner (A3Pro) (510k cleared)

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

full page →fda device 510k ↗

Sep 30, 2025device 510k334d agoWright Medical Technology, Inc. (Stryker Corporation) — Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom) (510k cleared)

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

full page →fda device 510k ↗

Sep 30, 2025device 510k334d agoFehling Instruments GmbH — Biopsy Forceps (510k cleared)

Product code: DWZ. Advisory committee: Cardiovascular. Type: Special

full page →fda device 510k ↗

Sep 30, 2025device 510k334d agoParagon 28, Inc. — External Fixation Mini Rail System (510k cleared)

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

full page →fda device 510k ↗

Sep 30, 2025device 510k334d agoCenters for Disease Control and Prevention — Francisella tularensis Real-time PCR assay (510k cleared)Hubei Provincial Center for Disease Control and Prevention

Product code: SGA. Advisory committee: Immunology. Type: Traditional

full page →fda device 510k ↗

Sep 30, 2025device 510k334d agoDistalmotion SA — Dexter L6 System (510k cleared)

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

full page →fda device 510k ↗

Sep 30, 2025device 510k334d agoArthrex, Inc. — Arthrex SpeedFLEX Implant (510k cleared)

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

full page →fda device 510k ↗

Sep 30, 2025device 510k334d agoShanghai Draeger Medical Instrument Co., Ltd. — IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP transducer adapter cable, Draeger 10-pin, 2m; IBP transducer adapter cable, Draeger 7-pin, 2m; IBP transd. adapter cbl, Abbott/Medex, Smiths/TranStar 2m; IBP transducer adapter cable, Baxter/Edwards, 0.3m; IBP transducer adapter cable, Baxter/Edwards, 2m; IBP transducer adapter cable, Argon/BD/Ohmeda, 0.3m; IBP transducer adapter cable, Draeger 10-pin, 0.3m; IBP transducer adapter cable, Draeger 7-pin, 0.3m; IBP transducer adapter (510k cleared)

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

full page →fda device 510k ↗

Sep 30, 2025device 510k334d agoTigerconnect — TigerConnect Alarm Management (510k cleared)

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

full page →fda device 510k ↗

Sep 30, 2025device pma334d agoAsahi Kasei Medical Co., Ltd. — Plasmaflo OP-05W(A) (PMA supplement)

Supplement type: Real-Time Process. Product code: MDP. Advisory committee: GU. Decision: APPR

full page →fda device pma ↗

Sep 30, 2025device pma334d agoBausch & Lomb, Inc. — Akreos Posterior Chamber Intraocular Lens (PMA supplement)Bausch & Lomb Corp

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

full page →fda device pma ↗

Sep 30, 2025device pma334d agoABBOTT MEDICAL — AVEIR Leadless Pacemaker Real-time Clock (RTC) electrical test (PMA supplement)

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

full page →fda device pma ↗

Sep 30, 2025device pma334d agoABBOTT MEDICAL — TriClip G4 Delivery System; TriClip G5 Delivery System (PMA supplement)

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

full page →fda device pma ↗

Sep 30, 2025device pma334d 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 ↗

Sep 30, 2025device pma334d agoABBOTT MEDICAL — MitraClip G4 Clip Delivery System; MitraClip G5 Delivery System (PMA supplement)

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

full page →fda device pma ↗

Sep 30, 2025device recall334d agoMedline Industries, LP device recall (Cls II)

MEDLINE convenience kits labeled as: 1) ACH PLASTICS BREAST-LF, REF CDS983639K; 2) BREAST ABD, REF CDS984267J; 3) PLASTIC PACK, REF DYNJ00264M; 4) BREAST ABDOMINOPLASTY MZ PK-LF, REF DYNJ0428947L; 5) BREAST ABDOMINOPLASTY MB PK-LF, REF DYNJ0428947M; 6) AUGMENTATION #87-RF, REF DYNJ27319V; 7) BREAST AUGMENTATION PACK, REF DYNJ33977M; 8) BREAST RECONSTRUCTION-HOULE, REF DYNJ44852M; 9) BREAST PACK, REF DYNJ57527C; 10) TRANSGENDER MASTECTOMY 2, REF DYNJ58257G; 11) ISS MAJOR BREAST PACK, REF DYNJ58668D; 12) CHEST/BREAST PACK, REF DYNJ66495A; 13) MAJOR PLASTICS PACK, REF DYNJ67968B; 14) BREAST PACK, REF DYNJ68464A; 15) BREAST PACK, REF DYNJ68464B; 16) PLASTIC PACK, REF DYNJ83856; 17) PLASTIC PACK, REF DYNJ83856A; 18) PLASTIC PACK, REF DYNJ83856B; 19) BREAST PACK, REF DYNJ84332A; 20) ACH PLASTICS BREAST PK-LF, REF DYNJ85111; 21) BREAST-CHEST, REF DYNJ900294L; 22) PLASTICS MASTECTOMY, REF DYNJ904966C; 23) BREAST PLASTIC, REF DYNJ906638B; 24) BREAST-CHEST, REF DYNJ907141B; 25) BREAST RECONSTRUCTION PACK, REF DYNJ907791B; 26) BREAST RECONSTRUCTION PACK, REF DYNJ907791D; 27) BREAST HERNIA, REF DYNJ908058A; 28) CHEST BREAST KIT, REF DYNJ909203A; 29) PLASTIC, REF DYNJ909410; 30) PLASTIC, REF DYNJ910440; 31) BREAST -LF, REF DYNJ9426113N; 32) GP-PLASTIC BREAST ABD PACK-LF, REF PHS397064007D. — Reason: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released. — Status: Ongoing

Sep 30, 2025device recall334d agoAlcon Research LLC device recall (Cls II)

Alcon PRECISION1 One-Day Contact Lenses, -2.25D. — Reason: Potential for a weak seal in some units resulting in compromise in sterility. — Status: Ongoing

full page →fda device recalls ↗

Sep 30, 2025device recall334d agoIMPRIS Imaging Inc device recall (Cls I)

IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siemens 3 Tesla MRI Magnet, Verio — Reason: There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. Siemens notified IMRIS that an ice blockage may exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed vent paths, leading to a pressure build-up within the helium containment system which could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room. — Status: Ongoing

full page →fda device recalls ↗

Sep 30, 2025device recall334d agoMedline Industries, LP device recall (Cls II)

MEDLINE convenience kits labeled as: CIRCUMCISION PACK, REF DYNJ16826O — Reason: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released. — Status: Ongoing

full page →fda device recalls ↗

Sep 30, 2025device recall334d agoPrismatik Dentalcraft, Inc. device recall (Cls II)

Brand Name: Inclusive Product Name: Inclusive Titanium Screw compatible with: Biomet 3i" Certain 3.4/4.1/5.0/6.0 mm Model/Catalog Number: 70-1047-COM0117 — Reason: Incorrect titanium screw, packaged with dental implant. — Status: Ongoing

full page →fda device recalls ↗

Sep 30, 2025device recall334d agoMedline Industries, LP device recall (Cls II)

MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S; 2) MINOR EYE TRAY #81, REF DYNJ27466T. — Reason: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released. — Status: Ongoing

full page →fda device recalls ↗

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