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20,454 catalysts · 4,728 grant · 3,282 device 510k · 3,118 8k filing · 2,831 approval · 2,000 device pma · 2,000 device recall

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2026-08-10: 0 catalysts2026-08-11: 89 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 510k3,282
  • 8k filing3,118
  • approval2,831
  • device pma2,000
  • device recall2,000
device adverse event
1,000
  • recall830
  • earnings583
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Apr 21, 2025

    50
    ›Apr 23, 2025device 510k476d agoLaon Medi, Inc. — Laon Ortho (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 23, 2025device 510k476d agoMedacta International S.A. — MySpine WebPlanner (510k cleared)Stemedica International S.A.

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

    full page →fda device 510k ↗
    ›Apr 24, 2025approval475d agoALEVE (NAPROXEN SODIUM) — FDA approvalNAPROXEN SODIUM

    Sponsor: BAYER. Form: TABLET. Route: ORAL

    full page →NAPROXEN SODIUM →fda approvals ↗
    ›Apr 24, 2025device 510k475d agoSurGenTec, LLC — ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 24, 2025device 510k475d agoFreespira, Inc. — Freespira Breathing System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 24, 2025device 510k475d agoShenzhen AOJ Medical Technology Co., Ltd. — Arm Blood Pressure Monitor (ARM-30H); Arm Blood Pressure Monitor (ARM-30J); Arm Blood Pressure Monitor (ARM-30K); Arm Blood Pressure Monitor (ARM-90B) (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Apr 24, 2025device 510k475d agoShenzhen Rogin Medical Co., Ltd. — Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 24, 2025device 510k475d agoIvylaser (Beijing) Technology Co.,Ltd — Diode laser system (Night Universe; Predator) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 24, 2025device 510k475d agoZhuozhou Summer Star Technologies Co., Ltd. — CO2 Laser System (CO2 Laser SST-L23) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 24, 2025device 510k475d agoGo-Pen Aps — GO-PEN® (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 24, 2025device 510k475d agoMentor Worldwide, LLC — MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 24, 2025device 510k475d agoIntuitive Surgical, Inc. — da Vinci SP Surgical System (SP1098) (510k cleared)INTUITIVE SURGICAL INC

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

    full page →fda device 510k ↗
    ›Apr 24, 2025device 510k475d agoSound Health Systems, Inc. — Sonu (510k cleared)Tivic Health Systems, Inc.

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

    full page →fda device 510k ↗
    ›Apr 24, 2025device 510k475d agoCirca Scientific, Inc. — PeriCross™ Epicardial Access Kit (510k cleared)Clear Scientific Inc

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

    full page →fda device 510k ↗
    ›Apr 24, 2025device 510k475d agoLife Spark Medical, LLC — Smart Check O2 (MA0236) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 24, 2025device 510k475d agoCanwell Medical Co., Ltd. — CanMINI Hand and Foot System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 24, 2025device 510k475d agoExo, Inc. — Lung AI (LAI001) (510k cleared)

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

    full page →fda device 510k ↗
    ›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 ↗
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    $TIVC
    $STE239.63+0.30%
    $ISRG400.03+1.69%
    $MMSI91.54+1.99%