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20,381 catalysts · 4,728 grant · 3,282 device 510k · 3,045 8k filing · 2,831 approval · 2,000 device pma · 2,000 device recall

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2026-08-10: 75 catalysts2026-08-11: 16 catalysts2026-08-12: 19 catalysts2026-08-13: 19 catalysts2026-08-14: 4 catalysts2026-08-15: 0 catalysts2026-08-16: 0 catalysts2026-08-17: 1 catalyst2026-08-18: 2 catalysts2026-08-19: 2 catalysts2026-08-20: 0 catalysts2026-08-21: 0 catalysts2026-08-22: 0 catalysts2026-08-23: 0 catalysts2026-08-24: 0 catalysts2026-08-25: 0 catalysts2026-08-26: 1 catalyst2026-08-27: 1 catalyst2026-08-28: 0 catalysts2026-08-29: 0 catalysts2026-08-30: 0 catalysts2026-08-31: 0 catalysts2026-09-01: 1 catalyst2026-09-02: 0 catalysts2026-09-03: 1 catalyst2026-09-04: 0 catalysts2026-09-05: 0 catalysts2026-09-06: 0 catalysts2026-09-07: 0 catalysts2026-09-08: 0 catalysts2026-09-09: 0 catalysts2026-09-10: 0 catalysts2026-09-11: 0 catalysts2026-09-12: 0 catalysts2026-09-13: 0 catalysts2026-09-14: 0 catalysts2026-09-15: 0 catalysts2026-09-16: 0 catalysts2026-09-17: 0 catalysts2026-09-18: 0 catalysts2026-09-19: 0 catalysts2026-09-20: 0 catalysts2026-09-21: 0 catalysts2026-09-22: 0 catalysts2026-09-23: 2 catalysts2026-09-24: 0 catalysts2026-09-25: 0 catalysts2026-09-26: 0 catalysts2026-09-27: 0 catalysts2026-09-28: 0 catalysts2026-09-29: 0 catalysts2026-09-30: 0 catalysts2026-10-01: 0 catalysts2026-10-02: 0 catalysts2026-10-03: 0 catalysts2026-10-04: 0 catalysts2026-10-05: 0 catalysts2026-10-06: 0 catalysts2026-10-07: 0 catalysts2026-10-08: 2 catalysts2026-10-09: 0 catalysts2026-10-10: 0 catalysts2026-10-11: 0 catalysts2026-10-12: 0 catalysts2026-10-13: 1 catalyst2026-10-14: 1 catalyst2026-10-15: 0 catalysts2026-10-16: 0 catalysts2026-10-17: 0 catalysts2026-10-18: 0 catalysts2026-10-19: 1 catalyst2026-10-20: 2 catalysts2026-10-21: 2 catalysts2026-10-22: 2 catalysts2026-10-23: 1 catalyst2026-10-24: 0 catalysts2026-10-25: 0 catalysts2026-10-26: 1 catalyst2026-10-27: 8 catalysts2026-10-28: 12 catalysts2026-10-29: 20 catalysts2026-10-30: 4 catalysts2026-10-31: 0 catalysts2026-11-01: 0 catalysts2026-11-02: 8 catalysts2026-11-03: 17 catalysts2026-11-04: 22 catalysts2026-11-05: 36 catalysts2026-11-06: 2 catalysts2026-11-07: 0 catalysts2026-11-08: 0 catalysts
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  • grant4,728
  • device 510k3,282
  • 8k filing3,045
  • approval2,831
  • device pma2,000
  • device recall2,000
  • device adverse event1,000
  • recall830
  • earnings578
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Apr 7, 2025

    46
    ›Apr 10, 2025approval488d agoVYVGART HYTRULO (EFGARTIGIMOD ALFA AND HYALURONIDASE-QVFC) — FDA approvalARGENX SE

    Sponsor: ARGENX BV. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Apr 10, 2025approval488d agoTEPADINA AND SODIUM CHLORIDE (THIOTEPA) — FDA approvalRevalesio Corp

    Sponsor: ADIENNE SA. Form: POWDER. Route: INTRAVENOUS

    full page →fda approvals ↗
    ›Apr 10, 2025approval488d agoLOPRESSOR (METOPROLOL TARTRATE) — FDA approvalmetoprolol tartrate

    Sponsor: RUBICON RESEARCH. Form: SOLUTION. Route: ORAL

    full page →metoprolol tartrate →fda approvals ↗
    ›Apr 10, 2025device 510k488d agoBrain Electrophysiology Laboratory Company, LLC — NEAT 001 (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 10, 2025device 510k488d agoKyocera Medical Technologies Inc. (KMTI) — Skyway Anterior Cervical Plate System (510k cleared)Medical Care Technologies Inc.

    Product code: KWQ. Advisory committee: Orthopedic. Type: Special

    full page →fda device 510k ↗
    ›Apr 10, 2025device 510k488d agoKyocera Medical Technologies, Inc. — Tesera-k SC System (510k cleared)Medical Care Technologies Inc.

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

    full page →fda device 510k ↗
    ›Apr 10, 2025device 510k488d agoDonnevie Medical Technology (Shanghai) Co. , Ltd. — Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit) (510k cleared)

    Product code: MQL. Advisory committee: Obstetrics/Gynecology. Type: Traditional

    full page →fda device 510k ↗
    ›Apr 10, 2025device 510k488d agoCanon Medical Informatics, Inc. — Vitrea CT VScore (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 10, 2025device 510k488d agoOrthofix Srl — FitboneTM Trochanteric (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 10, 2025device 510k488d agoVizionfocus, Inc. — Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 10, 2025device 510k488d agoTriMed, Inc. — TriMed® Compression Screws (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 10, 2025device 510k488d agoSiemens Medical Solutions USA, Inc. — syngo.CT LVO Detection (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 10, 2025device 510k488d agoPhilips Ultrasound, LLC — EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 10, 2025device 510k488d agoKyocera Medical Technologies, Inc. — Initia T3 Acetabular Hemispherical Shell System (510k cleared)Medical Care Technologies Inc.

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

    full page →fda device 510k ↗
    ›Apr 10, 2025device 510k488d agoJiangsu Ruifuda Medical Device Co., Ltd. — Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202) (510k cleared)

    Product code: MQL. Advisory committee: Obstetrics/Gynecology. Type: Traditional

    full page →fda device 510k ↗
    ›Apr 10, 2025device 510k488d agoCuremetrix, Inc. — cmAngio® (V1.6) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 10, 2025device 510k488d agoAtriCure, Inc. — cryoICE cryoXT cryoablation probe (cryoXT) (510k cleared)AtriCure, Inc.

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

    full page →fda device 510k ↗
    ›Apr 10, 2025device 510k488d agoPremium Plus (Dongguan) Limited — LED Curing Light (C01-X, C02-X) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 10, 2025device 510k488d agoChangzhou Xin Neng Yuan Medical Stapler Co.,Ltd — XNY Disposable Gastric Calibration Tube (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 11, 2025approval487d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

    Sponsor: BRISTOL MYERS SQUIBB. Form: INJECTABLE. Route: INJECTION

    full page →nivolumab →fda approvals ↗
    ›Apr 11, 2025approval487d agoSUBLOCADE (BUPRENORPHINE) — FDA approvalbuprenorphine LA

    Sponsor: INDIVIOR. Form: SOLUTION, EXTENDED RELEASE. Route: SUBCUTANEOUS

    full page →buprenorphine LA →fda approvals ↗
    ›Apr 11, 2025approval487d agoMORPHINE SULFATE — FDA approvalKapanol

    Sponsor: ACTAVIS ELIZABETH. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

    full page →Kapanol →fda approvals ↗
    ›Apr 11, 2025approval487d agoCABENUVA KIT (CABOTEGRAVIR) — FDA approvalViiV Healthcare Company

    Sponsor: VIIV HLTHCARE. Form: SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR

    full page →fda approvals ↗
    ›Apr 11, 2025device 510k487d agoFoshan Coxo Medical Instrument Co., Ltd. — LED Curing Lights (DB686 HALO) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 11, 2025device 510k487d agoNelson Environmental Technologies, Inc. — Chlorine Sentinel II (510k cleared)BION ENVIRONMENTAL TECHNOLOGIES INC

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

    full page →fda device 510k ↗
    ›Apr 11, 2025device 510k487d agoOncospace, Inc. — Oncospace (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 11, 2025device 510k487d agoSmartsurgN, Inc. — AirSurgN Insufflator (10030/AirSurgN) (510k cleared)

    Product code: HIF. Advisory committee: Obstetrics/Gynecology. Type: Traditional

    full page →fda device 510k ↗
    ›Apr 11, 2025device 510k487d agoShenzhen Trious Medical Technology Co., Ltd. — Disposable ureteral access sheath (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Apr 11, 2025device 510k487d agoAlma Lasers, Inc. — Alma Harmony (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 11, 2025device 510k487d agoFujifilm Corporation — FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R (510k cleared)Fujifilm Holdings Corp

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

    full page →fda device 510k ↗
    ›Apr 11, 2025device 510k487d agoXelite Biomed , Ltd. — XeliteMed VertehighFix High Viscosity Spinal Bone Cement System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 11, 2025device 510k487d agoCognoa, Inc. — Canvas Dx (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 11, 2025device 510k487d agoGuilin Aesthedent Medical Instruments Co., Ltd. — Dental Implant Unit (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 11, 2025device 510k487d agoDentsply Sirona — Atlantis® Abutments in Titanium (510k cleared)DENTSPLY SIRONA Inc.

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

    full page →fda device 510k ↗
    ›Apr 11, 2025device 510k487d agoShenzhen Vivolight Medical Device & Technology Co., Ltd. — Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 11, 2025device 510k487d agoKlaxon-Mobility GmbH — KLAXON (TWIST); KLAXON (TWIST R) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 11, 2025device 510k487d agoCooperSurgical, Inc. — CooperSurgical Milex® Pessaries (510k cleared)

    Product code: HHW. Advisory committee: Obstetrics/Gynecology. Type: Traditional

    full page →fda device 510k ↗
    ›Apr 11, 2025device 510k487d agoAidite (Qinhuangdao) Technology Co., Ltd. — Dental Zirconia Ceramic (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 11, 2025device 510k487d agoAsiga Pty, Ltd. — Asiga DentaBASE (510k cleared)

    Product code: EBI. Advisory committee: Dental. Type: Abbreviated

    full page →fda device 510k ↗
    ›Apr 11, 2025device 510k487d agoShanghai AnQing Medical Instrument Co., Ltd. — Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 11, 2025device 510k487d agoCascination AG — OTOPLAN (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 11, 2025device 510k487d agoClick Therapeutics, Inc. — CT-132 (510k cleared)Click Holdings Ltd.

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

    full page →fda device 510k ↗
    ›Apr 11, 2025device 510k487d agoPearl, Inc. — Second Opinion Periapical Radiolucency Contours (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 11, 2025device 510k487d agoRoche Molecular Systems, Inc. — cobas liat SARS-CoV-2 v2 nucleic acid test (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 11, 2025device 510k487d agoMedline Industries, LP — Medline UNITE® REFLEX® Hybrid Nitinol Implant System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 11, 2025device 510k487d agoGalileo Cds, Inc. — GBrain MRI (510k cleared)

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

    full page →fda device 510k ↗

    Week of Apr 14, 2025

    4
    ›Apr 14, 2025approval484d agoOTULFI (USTEKINUMAB-AAUZ) — FDA approvalOTULFI

    Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INJECTION

    full page →OTULFI →fda approvals ↗
    ›Apr 14, 2025approval
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    page 1 of 408
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    484d ago
    ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

    Sponsor: PHARMOBEDIENT. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Apr 14, 2025device 510k484d agoElfi-Tech , Ltd. — Elfor-L (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 14, 2025device 510k484d agoMediclus Co., Ltd. — Any-Com Flow (510k cleared)

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

    full page →fda device 510k ↗
    $ARGX866.11+0.12%
    $MDCE0.00020.00%
    $BNET
    $INDV38.47-0.90%
    $ATRC
    $MDCE0.00020.00%
    $MDCE0.00020.00%
    $BMY64.84+0.19%
    $CLIK
    $XRAY11.66-3.80%
    $IGC0.2670+0.41%