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12,161 catalysts · 3,603 8k filing · 2,283 grant · 1,765 approval · 1,146 device 510k · 1,000 device adverse event · 827 device pma

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  • 8k filing3,603
  • grant2,283
  • approval1,765
  • device 510k1,146
  • device adverse event1,000
  • device pma827
device recall
606
  • earnings585
  • recall266
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Dec 1, 2025

    50
    ›Dec 5, 2025approval267d agoONTRUZANT (TRASTUZUMAB-DTTB) — FDA approvalONTRUZANT

    Sponsor: SAMSUNG BIOEPIS CO LTD. Form: POWDER. Route: IV (INFUSION)

    full page →ONTRUZANT →fda approvals ↗
    ›Dec 5, 2025approval267d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

    Sponsor: HIBROW HLTHCARE. Form: SOLUTION. Route: ORAL

    full page →fda approvals ↗
    ›Dec 5, 2025approval267d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

    Sponsor: HIBROW HLTHCARE. Form: SOLUTION. Route: ORAL

    full page →fda approvals ↗
    ›Dec 5, 2025approval267d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

    Sponsor: HIBROW HLTHCARE. Form: SOLUTION. Route: ORAL

    full page →fda approvals ↗
    ›Dec 5, 2025approval267d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

    Sponsor: HIBROW HLTHCARE. Form: SOLUTION. Route: ORAL

    full page →fda approvals ↗
    ›Dec 5, 2025approval267d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

    Sponsor: HIBROW HLTHCARE. Form: SOLUTION. Route: ORAL

    full page →fda approvals ↗
    ›Dec 5, 2025approval267d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

    Sponsor: HIBROW HLTHCARE. Form: SOLUTION. Route: ORAL

    full page →fda approvals ↗
    ›Dec 5, 2025approval267d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

    Sponsor: GRANULES. Form: TABLET. Route: ORAL

    full page →acetaminophen ER →fda approvals ↗
    ›Dec 5, 2025approval267d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalEon Labs Inc

    Sponsor: CHARTWELL MOLECULAR. Form: SOLUTION. Route: ORAL

    full page →fda approvals ↗
    ›Dec 5, 2025approval267d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

    Sponsor: CHARTWELL. Form: SOLUTION. Route: ORAL

    full page →acetaminophen ER →fda approvals ↗
    ›Dec 5, 2025approval267d agoOXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalAmneal Pharmaceuticals, Inc.

    Sponsor: PH HEALTH. Form: SOLUTION. Route: ORAL

    full page →fda approvals ↗
    ›Dec 5, 2025approval267d agoRIFADIN (RIFAMPIN) — FDA approvalRIFADIN

    Sponsor: SANOFI AVENTIS US. Form: INJECTABLE. Route: INJECTION

    full page →RIFADIN →fda approvals ↗
    ›Dec 5, 2025approval267d agoRIFATER (ISONIAZID) — FDA approvalRIFATER

    Sponsor: SANOFI AVENTIS US. Form: TABLET. Route: ORAL

    full page →RIFATER →fda approvals ↗
    ›Dec 5, 2025approval267d agoILLUCCIX (GALLIUM GA-68 GOZETOTIDE) — FDA approvalILLUCCIX

    Sponsor: TELIX. Form: POWDER. Route: INTRAVENOUS

    full page →ILLUCCIX →fda approvals ↗
    ›Dec 5, 2025approval267d agoRIFADIN (RIFAMPIN) — FDA approvalRIFADIN

    Sponsor: SANOFI AVENTIS US. Form: CAPSULE. Route: ORAL

    full page →RIFADIN →fda approvals ↗
    ›Dec 5, 2025approval267d agoETICOVO (ETANERCEPT-YKRO) — FDA approvalETICOVO

    Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: INJECTION

    full page →ETICOVO →fda approvals ↗
    ›Dec 5, 2025approval267d agoAMANTADINE HYDROCHLORIDE — FDA approvalShinkei Therapeutics LLC

    Sponsor: SHREE HARI INTL. Form: SYRUP. Route: ORAL

    full page →fda approvals ↗
    ›Dec 5, 2025approval267d agoACETAMINOPHEN — FDA approvalIGC Pharma, Inc.

    Sponsor: CAPLIN. Form: SOLUTION. Route: INTRAVENOUS

    full page →fda approvals ↗
    ›Dec 5, 2025approval267d agoARIKAYCE KIT (AMIKACIN SULFATE) — FDA approvalamikacin sulfate PR

    Sponsor: INSMED INC. Form: SUSPENSION, LIPOSOMAL. Route: INHALATION

    full page →amikacin sulfate PR →fda approvals ↗
    ›Dec 5, 2025device 510k267d agoBlue Belt Technologies, Inc. — REAL INTELLIGENCE™ CORI™ XT (CORI XT) (510k cleared)BETA Technologies, Inc.

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

    full page →fda device 510k ↗
    ›Dec 5, 2025device 510k267d agoNeo Modulus (Suzhou) Medical Sci-Tech Co., Ltd. — Augmented Gingival Matrix (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2025device 510k267d agoManteia Technologies Co., Ltd. — ARTAssistant (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2025device 510k267d agoDornier Medtech America Inc (Dmta) — Dornier Bi-Polar Electrode BIP12CLM Bipolar 12° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP12CLL Bipolar 12° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLM Bipolar 30° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLL Bipolar 30° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIPMBLA Bipolar Medium Bladder Loop 24 Fr Electrode-Sterile, Single-Use BIPNEEL Bipolar Needle 24 Fr Electrode-Sterile, Single-Use BIPDDSC Bipolar Disc ) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2025device 510k267d agoKarl Storz SE & CO. KG — KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612) (510k cleared)

    Product code: EOQ. Advisory committee: Ear, Nose, Throat. Type: Special

    full page →fda device 510k ↗
    ›Dec 5, 2025device 510k267d agoEpic Medical Pte. , Ltd. — ProSeal™ Transfer Injector (421120, 421130, 421140) (510k cleared)

    Product code: ONB. Advisory committee: General Hospital. Type: Special

    full page →fda device 510k ↗
    ›Dec 5, 2025device 510k267d agoMediclus Co., Ltd. — Any-Core (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2025device 510k267d agoLincotek Medical — SpineLinc Anterior Cervical Implant System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2025device 510k267d agoJiangsu Jumao X-Care Medical Equipment Co., , Ltd. — Manual Wheelchair (W45) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2025device 510k267d agoRestor3D, Inc. — Velora Acetabular System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2025device 510k267d agoRemvia — Remvia NightGuard (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2025device 510k267d agoJiangsu Jumao X-Care Medical Equipment Co., , Ltd. — Manual Wheelchair (W47) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2025device 510k267d agoMedspira, LLC — mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2025device 510k267d agoNanjing Kangni Smart Technology Co., Ltd. — Electrically powered wheelchair (KZ301B) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2025device 510k267d agoShenzhen Siken 3D Technology Development Co., Ltd. — Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909, SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2025device 510k267d agoOverjet, Inc. — Overjet CBCT Assist (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2025device 510k267d agoHuinno Co., Ltd. — MEMO Patch M (MPT-E08R-UNC01) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2025device 510k267d agoSaremco Dental AG — els unibond (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2025device 510k267d agoQuietLab, LLC — QuietLab Pro (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2025device 510k267d agoAlimetry , Ltd. — Gastric Alimetry (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2025device 510k267d agoSonoscape Medical Corp. — Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11 Super/X11 Senior/X11/E11/E11 Pro/E11 Plus/E11 Elite/X11T/X11U/X11R/X11i/X11s/E11T/E11i/E11s/XR1/XR2/ XR3/ER1/ER2/ER3/X10 Exp/X10 Elite/X10 Pro/X10 Plus/X10 Super/X10 Senior/X10/X10T/X10U/ X10R/X10i/X10s/E10/E10 Pro/E10 Plus/E10T/E10i/E10s/SU11A EXP/SU11A PRO/SU11A AD/ SU11A CU/SU11B EXP/SU11B PRO/SU11B AD/SU11B CU/SU11C EXP/SU11C PRO/SU11C AD/ SU11C CU) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2025device 510k267d ago3D Systems, Inc. — VSP Orthopedics System (510k cleared)3D SYSTEMS CORP

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

    full page →fda device 510k ↗
    ›Dec 5, 2025device 510k267d agoW.O.M. World of Medicine GmbH — PUREVUE™ FMS (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2025device 510k267d agoOncopatch, Inc. — OncoPatch (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2025device 510k267d agoThermo Fisher Scientific (Oxoid Ltd.) — Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10 (510k cleared)THERMO FISHER SCIENTIFIC INC.

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

    full page →fda device 510k ↗
    ›Dec 5, 2025device 510k267d agoResmed Corp — Personalized Therapy Comfort Settings (PTCS) (510k cleared)RESMED INC

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

    full page →fda device 510k ↗
    ›Dec 5, 2025device pma267d agoBoston Scientific Corp — Intellagen™ Irrigation Tubing Set (PMA supplement)BOSTON SCIENTIFIC CORP

    Supplement type: Normal 180 Day Track. Product code: OAD. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Dec 5, 2025device pma267d agoCooperVision, Inc. — Sofmed® breathables™ XW NEXT (PMA supplement)

    Supplement type: Normal 180 Day Track No User Fee. Product code: LPM. Advisory committee: OP. Decision: APPR

    full page →fda device pma ↗
    ›Dec 5, 2025device pma267d agoW. L. Gore and Associates, Inc. — GORE® EXCLUDER® Conformable AAA Endoprosthesis (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 5, 2025device pma267d agoMedtronic Minimed, Inc. — Simplera Sync Sensor (PMA supplement)Medtronic USA Inc

    Supplement type: 30-Day Notice. Product code: SFI. Advisory committee: CH. Decision: OK30

    full page →fda device pma ↗
    ›Dec 5, 2025device pma267d agoMedtronic Minimed — Simplera System (PMA supplement)

    Supplement type: 30-Day Notice. Product code: MDS. Advisory committee: CH. Decision: OK30

    full page →fda device pma ↗
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