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calendar

20,120 catalysts · 4,728 grant · 3,126 8k filing · 3,076 device 510k · 2,774 approval · 2,000 device pma · 2,000 device recall

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2026-08-10: 0 catalysts2026-08-11: 97 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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type
  • grant4,728
  • 8k filing3,126
  • device 510k3,076
  • approval2,774
  • device pma2,000
  • device recall2,000
  • device adverse event1,000
  • recall751
  • earnings583
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of May 19, 2025

    37
    ›May 22, 2025device 510k447d 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 510k447d 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 510k447d 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 510k447d 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 510k447d 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 510k447d 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 510k447d 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 510k447d 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, 2025approval446d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

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

    full page →nivolumab →fda approvals ↗
    ›May 23, 2025approval446d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

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

    full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
    ›May 23, 2025approval446d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

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

    full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
    ›May 23, 2025approval446d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

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

    full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
    ›May 23, 2025approval446d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

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

    full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
    ›May 23, 2025approval446d agoWAKIX (PITOLISANT HYDROCHLORIDE) — FDA approvalpitolisant hydrochloride

    Sponsor: HARMONY. Form: TABLET. Route: ORAL

    full page →pitolisant hydrochloride →fda approvals ↗
    ›May 23, 2025approval446d agoBOSUTINIB MONOHYDRATE — FDA approvalBOSUTINIB MONOHYDRATE

    Sponsor: ALEMBIC. Form: TABLET. Route: ORAL

    full page →BOSUTINIB MONOHYDRATE →fda approvals ↗
    ›May 23, 2025approval446d 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 510k446d agoPearl, Inc. — Second Opinion® 3D (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k446d agoPiraeus Medical — 93 NeuFlex Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k446d agoKuros Biosciences B.V — MagnetOs MIS (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k446d agoGeske Beauty Tech GmbH — SmartAppGuidedTM MicroCurrent Face-Lift Pen 6 in 1 (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k446d agoShenzhen Ulike Smart Electronics Co., Ltd. — Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 GR, MI01 PP, MI01 RM, MI01 WG, MI01 WH, MI01 BK;UI04S PP, UI04S BU, UI04S WH, UI04S PN) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k446d agoLVIS Corporation — NeuroMatch (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k446d agoThe Binding Site Group , Ltd. — Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit (510k cleared)Dawn Sea Therapeutics

    Product code: DFH. Advisory committee: Immunology. Type: Traditional

    full page →fda device 510k ↗
    ›May 23, 2025device 510k446d agoEizo Corporation — RadiForce MX317W-PA (510k cleared)

    Product code: PZZ. Advisory committee: Pathology. Type: Abbreviated

    full page →fda device 510k ↗
    ›May 23, 2025device 510k446d agoEwoosoft Co., Ltd. — Clever One (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k446d agoDepuy Ireland UC — RECLAIM Monobloc Revision Femoral Stem (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k446d agoEl Global Trade, Ltd. — IPL400 (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k446d agoSpineup, Inc. — Frida™ Anterior Cervical Plate System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k446d agoWellell, Inc. — WiZARD 520 Full Face Mask (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k446d agoABBOTT MEDICAL — ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid Mapping Catheter, Sensor Enabled™; Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™; Agilis™ NxT Steerable Introducer; Agilis™ NxT Steerable Introducer Dual-Reach™ (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k446d agoVenocare, Inc. — Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k446d agoDsi Dental Solutions, Ltd. — Sil-Flow (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k446d agoRivanna Medical, Inc. — Accuro 3S (510k cleared)Vivani Medical, Inc.

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k446d agoBrain Navi Biotechnology Co., Ltd. — Stereotaxic Guiding Surgical Devices, NaoTrac S (510k cleared)Avistone Biotechnology Co Ltd

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k446d agoFujifilm Corporation — FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L (510k cleared)Fujifilm Holdings Corp

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k446d agoDeepecho — DEEPECHO (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k446d agoStryker Endoscopy — Knotilus+ Biocomposite Knotless Anchor (510k cleared)

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

    full page →fda device 510k ↗

    Week of May 26, 2025

    13
    ›May 27, 2025device 510k442d agoPuritan Medical Products, LLC — Puritan PurSafe Plus Collection and Transport System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 27, 2025device 510k
    ← prev
    page 6 of 403
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    442d ago
    Distalmotion SA — Dexter L6 System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 27, 2025device 510k442d agoPreventamed Technologies, Inc. Dba Surfacide Manufacturing — Helios+ UV-C System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 27, 2025device 510k442d agoNingbo Baichen Medical Devices Co., Ltd. — Electric Wheelchair (BC-EA5516, BC-EC8002, BC-EC8003, BC-EALD3) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 27, 2025device 510k442d agoOSSIO , Ltd. — OSSIOfiber® Suture Anchor (510k cleared)

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

    full page →fda device 510k ↗
    ›May 27, 2025device 510k442d agoMedicalgorithmics S.A. — DeepRhythmAI (510k cleared)

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

    full page →fda device 510k ↗
    ›May 27, 2025device 510k442d agoJjgc Indústria E Comércia DE Materiais Dentários S.A. — Neodent Implant System - Custom Abutments (510k cleared)

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

    full page →fda device 510k ↗
    ›May 27, 2025device 510k442d agoTheodent, LLC — Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Varnish (3% / Cherry); Rennou™ Varnish (3% / Bubble Gum) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 27, 2025device 510k442d agoShofu Dental Corporation — BEAUTIFIL II (510k cleared)

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

    full page →fda device 510k ↗
    ›May 27, 2025device 510k442d agoOlympus Medical Systems Corp. — Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614M (510k cleared)

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

    full page →fda device 510k ↗
    ›May 27, 2025device 510k442d agoMipont Medical Equipment Co., Ltd. — Integral Dental Units (510k cleared)

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

    full page →fda device 510k ↗
    ›May 27, 2025device 510k442d agoABBOTT MEDICAL — Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 28, 2025approval441d agoTRULICITY (DULAGLUTIDE) — FDA approvaldulaglutide

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

    full page →dulaglutide →fda approvals ↗
    $VANI1.6000+18.52%
    $BMY63.75-1.68%
    $BMY63.75-1.68%
    $HRMY39.37+0.95%
    $TMO447.81+1.31%
    $LLY1223.99-0.64%