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20,807 catalysts · 4,728 grant · 3,382 8k filing · 3,346 device 510k · 2,850 approval · 2,000 device pma · 2,000 device recall

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2026-08-17: 33 catalysts2026-08-18: 2 catalysts2026-08-19: 3 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 catalysts2026-11-09: 1 catalyst2026-11-10: 0 catalysts2026-11-11: 0 catalysts2026-11-12: 0 catalysts2026-11-13: 0 catalysts2026-11-14: 0 catalysts2026-11-15: 0 catalysts
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  • grant4,728
  • 8k filing3,382
  • device 510k3,346
  • approval2,850
  • device pma2,000
  • device recall2,000
device adverse event
1,000
  • recall836
  • earnings584
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of May 19, 2025

    50
    ›May 21, 2025device 510k454d agoMem Dental Technology Co., Ltd. — MEM Clear Aligner System (510k cleared)Meiwu Technology Co Ltd

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

    full page →fda device 510k ↗
    ›May 21, 2025device 510k454d agoFujifilm Corporation — Synapse 3D Base Tools (V7.0) (510k cleared)Fujifilm Holdings Corp

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

    full page →fda device 510k ↗
    ›May 21, 2025device 510k454d agoRay Co., Ltd. — SMARTDent (510k cleared)Ray Therapeutics Inc

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

    full page →fda device 510k ↗
    ›May 21, 2025device 510k454d agoIntegrity Implants Inc. Dba Accelus — FlareHawk Interbody Fusion System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 21, 2025device 510k454d agoSpinal Elements, Inc. — The Karma® Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 21, 2025device 510k454d agoVoco GmbH — GrandioSO Unlimited (510k cleared)

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

    full page →fda device 510k ↗
    ›May 21, 2025device 510k454d agoStryker Endoscopy — Stryker AlphaVent™ Knotless SP Biocomposite Anchor (510k cleared)

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

    full page →fda device 510k ↗
    ›May 21, 2025device 510k454d agoHyperfine, Inc. — Swoop® Portable MR Imaging® System (510k cleared)Hyperfine, Inc.

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

    full page →fda device 510k ↗
    ›May 21, 2025device 510k454d agoPrintbio, Inc. — 3DMatrix DynaFlex (DynaFlex) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 21, 2025device 510k454d agoHjy Smart Medical Device Co., Ltd. — HJY VisualNext 3D Endoscopic Vision System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 21, 2025device 510k454d agoTandem Diabetes Care, Inc. — Control-IQ+ technology (510k cleared)TANDEM DIABETES CARE INC

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

    full page →fda device 510k ↗
    ›May 21, 2025device 510k454d agoFinemedix Co., Ltd. — ClearHemograsper (510k cleared)

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

    full page →fda device 510k ↗
    ›May 21, 2025device 510k454d 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 ↗
    ›May 21, 2025device 510k454d agoInVision Medical Technology Corporation — InVision Precision Cardiac Amyloid (510k cleared)

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

    full page →fda device 510k ↗
    ›May 21, 2025device 510k454d agoAnx Robotica Corporation — MotiliCap GI Monitoring System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 21, 2025device 510k454d agoAlma Lasers, Inc. — The Alma Hybrid Laser System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 22, 2025approval453d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

    Sponsor: MERCK SHARP DOHME. Form: SOLUTION. Route: INTRAVENOUS

    full page →pembrolizumab →fda approvals ↗
    ›May 22, 2025approval453d agoKALYDECO (IVACAFTOR) — FDA approvalVertex, Inc.

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

    full page →fda approvals ↗
    ›May 22, 2025approval453d agoKALYDECO (IVACAFTOR) — FDA approvalivacaftor

    Sponsor: VERTEX PHARMS INC. Form: GRANULE. Route: ORAL

    full page →ivacaftor →fda approvals ↗
    ›May 22, 2025approval453d agoISOTRETINOIN — FDA approvalZydus Therapeutics Inc

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

    full page →fda approvals ↗
    ›May 22, 2025approval453d agoTECHNESCAN PYP KIT (TECHNETIUM TC-99M PYROPHOSPHATE KIT) — FDA approval

    Sponsor: CURIUM. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›May 22, 2025approval453d agoTECHNESCAN HDP (TECHNETIUM TC-99M OXIDRONATE KIT) — FDA approval

    Sponsor: CURIUM. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›May 22, 2025approval453d agoLUPRON DEPOT-PED KIT (LEUPROLIDE ACETATE) — FDA approvalAmneal Pharmaceuticals, Inc.

    Sponsor: ABBVIE ENDOCRINE INC. Form: POWDER. Route: INTRAMUSCULAR

    full page →fda approvals ↗
    ›May 22, 2025approval453d agoEBGLYSS (LEBRIKIZUMAB-LBKZ) — FDA approvallebrikizumab

    Sponsor: ELI LILLY AND CO. Form: INJECTABLE. Route: INJECTION

    full page →lebrikizumab →fda approvals ↗
    ›May 22, 2025device 510k453d agoBasic Medical Technology, Inc. — Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate (510k cleared)Medical Care Technologies Inc.

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

    full page →fda device 510k ↗
    ›May 22, 2025device 510k453d agoHua Yue Medical Technology Co., Ltd. — Harioculture TL-16 Time-lapse Incubator (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›May 22, 2025device 510k453d agoUrotronic, Inc. — Optilume® High Pressure Urological Balloon Dilation Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›May 22, 2025device 510k453d agoClinical Innovations, LLC — Koala Intrauterine Pressure Catheter (IPC-5000E) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 22, 2025device 510k453d agoTriMed, Inc. — TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System (Fifth Metatarsal Screw) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 22, 2025device 510k453d agoOrtho Development Corp. — Trivicta® Hip Stem (510k cleared)DeFi Development Corp.

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

    full page →fda device 510k ↗
    ›May 22, 2025device 510k453d agoCryoconcepts LP — Skin Clinic Freeze Point for Warts and Skin Tags (510k cleared)

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

    full page →fda device 510k ↗
    ›May 22, 2025device 510k453d agoRandox Laboratories, Ltd. — ConcizuTrace™ ELISA (510k cleared)Rafa Laboratories Co Ltd

    Product code: SES. Advisory committee: Hematology. Type: Direct

    full page →fda device 510k ↗
    ›May 22, 2025device 510k453d agoArthrex, Inc. — Arthrex Spine Compression FT Screw (510k cleared)

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

    full page →fda device 510k ↗
    ›May 22, 2025device 510k453d agoOvesco Endoscopy AG — ArgoCap (200.52) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 22, 2025device 510k453d agoJiangsu Yuyue Medical Equipment & Supply Co., Ltd. — YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 22, 2025device 510k453d agoTerrats Medical SL — DESS Dental Smart Solutions (510k cleared)

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

    full page →fda device 510k ↗
    ›May 22, 2025device 510k453d agoLima Corporate S.P.A. — Physica System (Physica CR Porous Femoral components) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 22, 2025device 510k453d agoThermo Fisher Scientific — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mL (510k cleared)THERMO FISHER SCIENTIFIC INC.

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

    full page →fda device 510k ↗
    ›May 22, 2025device 510k453d agoShenzhen Kaiyan Medical Equipment Co., Ltd. — Solawave 2-in-1 Skincare Mini (Model: 61043) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025approval452d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

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

    full page →nivolumab →fda approvals ↗
    ›May 23, 2025approval452d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

    Sponsor: YICHANG HUMANWELL. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
    ›May 23, 2025approval452d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

    Sponsor: YICHANG HUMANWELL. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
    ›May 23, 2025approval452d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

    Sponsor: YICHANG HUMANWELL. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
    ›May 23, 2025approval452d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

    Sponsor: YICHANG HUMANWELL. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
    ›May 23, 2025approval452d agoWAKIX (PITOLISANT HYDROCHLORIDE) — FDA approvalpitolisant hydrochloride

    Sponsor: HARMONY. Form: TABLET. Route: ORAL

    full page →pitolisant hydrochloride →fda approvals ↗
    ›May 23, 2025approval452d agoBOSUTINIB MONOHYDRATE — FDA approvalBOSUTINIB MONOHYDRATE

    Sponsor: ALEMBIC. Form: TABLET. Route: ORAL

    full page →BOSUTINIB MONOHYDRATE →fda approvals ↗
    ›May 23, 2025approval452d agoOPDIVO QVANTIG (NIVOLUMAB) — FDA approval(hyaluronidase (recombinant, human) + nivolumab)

    Sponsor: BRISTOL-MYERS SQUIBB. Form: INJECTABLE. Route: SUBCUTANEOUS

    full page →(hyaluronidase (recombinant, human) + nivolumab) →fda approvals ↗
    ›May 23, 2025device 510k452d agoPearl, Inc. — Second Opinion® 3D (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k452d agoPiraeus Medical — 93 NeuFlex Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k452d agoKuros Biosciences B.V — MagnetOs MIS (510k cleared)

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

    full page →fda device 510k ↗
    ← prev
    page 14 of 417
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