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20,205 catalysts · 4,728 grant · 3,149 device 510k · 3,086 8k filing · 2,804 approval · 2,000 device pma · 2,000 device recall

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2026-08-10: 0 catalysts2026-08-11: 57 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: 21 catalysts2026-10-30: 4 catalysts2026-10-31: 0 catalysts2026-11-01: 0 catalysts2026-11-02: 9 catalysts2026-11-03: 18 catalysts2026-11-04: 22 catalysts2026-11-05: 37 catalysts2026-11-06: 2 catalysts2026-11-07: 0 catalysts2026-11-08: 0 catalysts
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  • grant4,728
  • device 510k3,149
  • 8k filing3,086
  • approval2,804
  • device pma2,000
  • device recall2,000
device adverse event
1,000
  • recall773
  • earnings583
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Apr 21, 2025

    35
    ›Apr 25, 2025approval474d agoLAMICTAL ODT (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

    Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

    full page →LAMOTRIGINE →fda approvals ↗
    ›Apr 25, 2025approval474d agoLAMICTAL ODT (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

    Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

    full page →LAMOTRIGINE →fda approvals ↗
    ›Apr 25, 2025approval474d agoLAMICTAL (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

    Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET. Route: ORAL

    full page →LAMOTRIGINE →fda approvals ↗
    ›Apr 25, 2025approval474d agoLAMICTAL (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

    Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET. Route: ORAL

    full page →LAMOTRIGINE →fda approvals ↗
    ›Apr 25, 2025approval474d agoLAMICTAL CD (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

    Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, FOR SUSPENSION. Route: ORAL

    full page →LAMOTRIGINE →fda approvals ↗
    ›Apr 25, 2025approval474d agoLAMICTAL CD (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

    Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, FOR SUSPENSION. Route: ORAL

    full page →LAMOTRIGINE →fda approvals ↗
    ›Apr 25, 2025approval474d agoLAMICTAL XR (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

    Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →LAMOTRIGINE →fda approvals ↗
    ›Apr 25, 2025approval474d agoLAMICTAL XR (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

    Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →LAMOTRIGINE →fda approvals ↗
    ›Apr 25, 2025device 510k474d agoMicroaire Surgical Instruments, LLC — PAL 7020 Console (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 25, 2025device 510k474d agoMako Surgical Corp. — Mako Total Knee Application (3.0); Hybrid Tip Pointer (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 25, 2025device 510k474d agoCardio Flow Inc., — FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 25, 2025device 510k474d agoVarian Medical Systems — Intracavitary/Interstitial System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 25, 2025device 510k474d agoPromethean Restorative, LLC — DYNAMIS™ Implant System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 25, 2025device 510k474d agoEchoNous, Inc. — Kosmos (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 25, 2025device 510k474d agoWellmed Dental Medical Supply Co., Ltd. — Self Sealing Sterilization Pouches (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 25, 2025device 510k474d agoSorin Group Italia S.R.L. — DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 25, 2025device 510k474d agoA.M.I. Agency For Medical Innovations GmbH — i-Cut (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 25, 2025device 510k474d agoRoche Molecular Systems, Inc. — cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 25, 2025device 510k474d agoBhm-Tech Produktionsgesellschaft Mbh — contact forte Alpha (510k cleared)

    Product code: LXB. Advisory committee: Ear, Nose, Throat. Type: Traditional

    full page →fda device 510k ↗
    ›Apr 25, 2025device 510k474d ago4Web Medical — Cervical Spine Truss System (CSTS) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 25, 2025device 510k474d agoRoche Molecular Systems, Inc. — cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 25, 2025device 510k474d agoMerit Medical Systems, Inc. — Prelude Wave Hydrophilic Sheath Introducer (510k cleared)MERIT MEDICAL SYSTEMS INC

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

    full page →fda device 510k ↗
    ›Apr 25, 2025device 510k474d agoAgnes Medical Co., Ltd. — RFMagik Lite (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 25, 2025device 510k474d agoShenzhen Urion Technology Co., Ltd. — Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Apr 25, 2025device 510k474d agoInstitut Geroges Lopez — DCX Disposable Cassette (DCX) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 25, 2025device 510k474d agoCompact Medical, Inc. — butterflyBVM (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 25, 2025device 510k474d agoL&K BIOMED Co., Ltd. — CastleLoc Pectus Bar System (510k cleared)NeuCen BioMed Co Ltd

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

    full page →fda device 510k ↗
    ›Apr 25, 2025device 510k474d agoNeuhealth Digital , Ltd. — Neu Platform (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 25, 2025device 510k474d agoCarefusion 303, Inc. — BD Alaris Infusion System with Guardrails Suite MX (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 25, 2025device 510k474d agoSTERIS Corporation — VERIFY STEAM Integrating Indicator (510k cleared)STERIS plc

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

    full page →fda device 510k ↗
    ›Apr 25, 2025device 510k474d agoGuangzhou Daxin Health Technology Co., Ltd. — Infrared Thermometer (510k cleared)Guangzhou Dazhou Biomedical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Apr 25, 2025device 510k474d agoCentinel Spine, LLC — prodisc® L Instruments (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 25, 2025device 510k474d agoSiemens Healthcare Diagnostics — Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L) (510k cleared)

    Product code: JLW. Advisory committee: Clinical Chemistry. Type: Traditional

    full page →fda device 510k ↗
    ›Apr 25, 2025device 510k474d agoABBOTT MEDICAL — Amulet™ Steerable Delivery Sheath (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 26, 2025device 510k473d agoCro, LLC — AIRO Suction Unit (AIRO-01) (510k cleared)

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

    full page →fda device 510k ↗

    Week of Apr 28, 2025

    15
    ›Apr 28, 2025approval471d agoSPRAVATO (ESKETAMINE HYDROCHLORIDE) — FDA approvalJanssen Therapeutics

    Sponsor: JANSSEN PHARMS. Form: SPRAY. Route: NASAL

    full page →fda approvals ↗
    ›Apr 28, 2025approval
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    471d ago
    STEQEYMA (USTEKINUMAB-STBA) — FDA approvalSTEQEYMA

    Sponsor: CELLTRION, INC.. Form: INJECTABLE. Route: SUBCUTANEOUS

    full page →STEQEYMA →fda approvals ↗
    ›Apr 28, 2025approval471d agoRINVOQ (UPADACITINIB) — FDA approvalupadacitinib tartrate ER

    Sponsor: ABBVIE. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →upadacitinib tartrate ER →fda approvals ↗
    ›Apr 28, 2025device 510k471d agoBeijing Nubway S&T Co., Ltd. — Diode laser hair removal machine (QDTM-02) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 28, 2025device 510k471d agoSuturion AB — Suture-TOOL System (510k cleared)

    Product code: NEW. Advisory committee: General, Plastic Surgery. Type: Special

    full page →fda device 510k ↗
    ›Apr 28, 2025device 510k471d agoAventamed Dac — Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000)) (510k cleared)

    Product code: ETD. Advisory committee: Ear, Nose, Throat. Type: Traditional

    full page →fda device 510k ↗
    ›Apr 28, 2025device 510k471d agoEminent Spine — Eminent Spine 3D Titanium Pedicle Screw System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 28, 2025device 510k471d agoShanghai United Imaging Healthcare Co., Ltd. — uAngio AVIVA CX (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 28, 2025device 510k471d agoContra Healthcare Solutions, LLC — LumiRex Ureteroscope (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 28, 2025device 510k471d agoAlembic, LLC — APRO 55 Swift Catheter and Alembic Aspiration Tubing (510k cleared)Alembic Pharmaceuticals Inc

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

    full page →fda device 510k ↗
    ›Apr 28, 2025device 510k471d agoZhe Jiang Cleisman Industry and Trade Co.,Ltd — Electric Wheelchair (ZH-W001,ZH-W002 ,ZH-W003) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 28, 2025device 510k471d agoAlcon Laboratories, Inc. — LenSx Laser System (8065998162) (510k cleared)Alcon Laboratories Inc

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

    full page →fda device 510k ↗
    ›Apr 28, 2025device 510k471d agoPhilips Ultrasound, LLC — Flash Ultrasound System 5100 Point of Care (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 29, 2025approval470d agoDIVIGEL (ESTRADIOL) — FDA approvalVertical Pharmaceuticals LLC

    Sponsor: VERTICAL PHARMS. Form: GEL. Route: TRANSDERMAL

    full page →fda approvals ↗
    ›Apr 29, 2025approval470d agoBLINCYTO (BLINATUMOMAB) — FDA approvalblinatumomab

    Sponsor: AMGEN. Form: INJECTABLE. Route: INJECTION

    full page →blinatumomab →fda approvals ↗
    $STE239.63+0.30%
    $FRTRY
    $MMSI91.54+1.99%
    $ABBV247.97+0.78%
    $AMGN417.20+1.52%