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1,479 catalysts · 3,350 8k filing · 2,401 grant · 2,136 approval · 1,479 device 510k · 1,105 device recall · 1,000 device adverse event

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2026-08-10: 0 catalysts2026-08-11: 0 catalysts2026-08-12: 0 catalysts2026-08-13: 0 catalysts2026-08-14: 0 catalysts2026-08-15: 0 catalysts2026-08-16: 0 catalysts2026-08-17: 1 catalyst2026-08-18: 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 catalysts
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type: device 510k×from 2025-10-24×clear all
type
  • 8k filing3,350
  • grant2,401
  • approval2,136
  • device 510k1,479
  • device recall1,105
  • device adverse event1,000
device pma
977
  • earnings584
  • recall376
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Oct 20, 2025

    24
    ›Oct 24, 2025device 510k296d agoCoroventis Research AB — CoroFlow Cardiovascular System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 24, 2025device 510k296d agoBeijing Fule Science & Technology Development Co., Ltd. — Fule Spinal Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 24, 2025device 510k296d agoMedtronic Sofamor Danek USA, Inc. — CD Horizon™ Spinal System (510k cleared)Medtronic USA Inc

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

    full page →fda device 510k ↗
    ›Oct 24, 2025device 510k296d agoPhilips Medical Systems Nederland B.V. — LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 24, 2025device 510k296d agoVesalio, Inc. — Vesalio Peripheral System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 24, 2025device 510k296d agoOlympus Medical Systems Corp. — Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 24, 2025device 510k296d agoDexcowin Global, Inc. — Cocoon Solo (DX-7020s) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 24, 2025device 510k296d agoMedivance, Inc. — Arctic Sun Temperature Management System (Model 5000) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 24, 2025device 510k296d agoHowmedica Osteonics Corp., Dba Stryker Orthopaedics — Triathlon® Total Knee System - Triathlon® Gold Femoral Components (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 24, 2025device 510k296d agoAbbott Ireland — Glucose2 (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 24, 2025device 510k296d agoPhilips Medical Systems B.V. — Azurion R3.1 (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 24, 2025device 510k296d agoSpectrum Spine, Inc. — Expandable Titanium PLIF/TLIF System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 24, 2025device 510k296d agoMedline Industries, LP — Medline Bag Decanter (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 24, 2025device 510k296d agoWandercraft SAS — Atalante X (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 24, 2025device 510k296d agoMedtronic - Sofradim Production — Parietene™ Flat Sheet Mesh (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 24, 2025device 510k296d agoSiemens Healthineers AG — Syngo Carbon Clinicals (VA41) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 24, 2025device 510k296d agoJkh Health Co., Ltd. — Cryon-X Cold Compression (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 24, 2025device 510k296d agoSolutions For Tomorrow AB — Mobile X-ray unit (!M1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 24, 2025device 510k296d agoGood Sleep CO Pte , Ltd. — Hushd Pro Z-Link (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 24, 2025device 510k296d agoAngioDynamics, Inc. — AngioVac Cannula (510k cleared)ANGIODYNAMICS INC

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

    full page →fda device 510k ↗
    ›Oct 24, 2025device 510k296d agoRoche Diagnostics — CoaguChek XS Plus System (510k cleared)

    Product code: GJS. Advisory committee: Hematology. Type: Special

    full page →fda device 510k ↗
    ›Oct 24, 2025device 510k296d agoMedtronic Sofamor Danek USA, Inc. — Infinity™ OCT System (510k cleared)Medtronic USA Inc

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

    full page →fda device 510k ↗
    ›Oct 24, 2025device 510k296d agoUnity Medical, Inc. — VersaD Delivery Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 24, 2025device 510k296d agoManteia Technologies Co., Ltd. — AccuCheck (510k cleared)

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

    full page →fda device 510k ↗

    Week of Oct 27, 2025

    26
    ›Oct 27, 2025device 510k293d agoCircle Cardiovascular Imaging, Inc. — cvi42 Coronary Plaque Software Application (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 27, 2025device 510k
    ← prev
    page 1 of 30
    next →
    293d ago
    Patriot Laser, LLC — Patriot Duo (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 27, 2025device 510k293d agoShenzhen Jamr Technology Co., Ltd. — Blood Pressure Monitor (B73, BE23T) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Oct 27, 2025device 510k293d agoOsteocentric Technologies, Inc. — OsteoCentric Navigated Instruments System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 27, 2025device 510k293d agoTouchbeauty Beauty & Health ( Shenzhen ) Co., Ltd — VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 27, 2025device 510k293d agoTechfit Digital Surgery, Inc. — TECHFIT Patient-Specific Cranial System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 27, 2025device 510k293d agoFimilla (Shanghai) Maternity & Baby Articles Co., Ltd. — Electric Breast Pump (HL-3058, F5112) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 27, 2025device 510k293d agoViet Phu Trade and Import Export Co., Ltd. — Disposable Vinyl Examination Gloves (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 27, 2025device 510k293d agoAffinity Biosensors, LLC — LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 27, 2025device 510k293d agoFimilla (Shanghai) Maternity & Baby Articles Co., Ltd. — Electric Breast Pump (HL-3060, F5113) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 28, 2025device 510k292d agoVolcano Corporation (Dba Philips Image Guided Therapy Device — Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 28, 2025device 510k292d agoCg Medtech Co., Ltd. — UniSpace® TPLIF Cage (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 28, 2025device 510k292d agoBaylis Medical Technologies, Inc. — PrecisePath™ Radiofrequency Puncture Generator and PrecisePath™ Footswitch (510k cleared)Medical Care Technologies Inc.

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

    full page →fda device 510k ↗
    ›Oct 28, 2025device 510k292d agoBoston Scientific Corporation — TheraSphere 360™ Y-90 Management Platform (510k cleared)BOSTON SCIENTIFIC CORP

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

    full page →fda device 510k ↗
    ›Oct 28, 2025device 510k292d agoWellell, Inc. — VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System (PM01D01 / Calf garment (S)); VenAir, Sequential Compression System (PM01E01 / Calf garment (M)); VenAir, Sequential Compression System (PM01F01 / Calf garment (L)); VenAir, Sequential Compression System (PM01G01 / Thigh garment (S)); VenAir, Sequential Compression System (PM01H01 / Thigh garment (M)); VenAir, Sequential Compression System (PM01I01 / Thigh garment (L)); VenAir, Sequential Compr (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 28, 2025device 510k292d agoBodycad Laboratories, Inc. — Fine Osteotomy™ (510k cleared)Barr Laboratories Inc

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

    full page →fda device 510k ↗
    ›Oct 28, 2025device 510k292d agoTyber Medical, LLC — Navigated Instruments (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 28, 2025device 510k292d agoShofu Dental Corporation — ZIRCONOMER P (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 28, 2025device 510k292d agoNeocis, Inc. — Yomi S Robotic System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 29, 2025device 510k291d agoGE Medical Systems Ultrasound and Primary Care Diagnostics — LOGIQ E10 (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 29, 2025device 510k291d agoHuxley Medical — SANSA HSAT (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 29, 2025device 510k291d agoWright Medical Technology, Inc. (Stryker Corporation) — Synchfix EVT (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 29, 2025device 510k291d agoGE Medical Systems Ultrasound and Primary Care Diagnostics — LOGIQ E10s (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 29, 2025device 510k291d agoInari Medical — Protrieve Sheath (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 29, 2025device 510k291d agoMedtronic, Ireland — Telescope Guide Extension Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 29, 2025device 510k291d agoSmith & Nephew, Inc. — AETOS Shoulder System Meta Humeral Prosthesis Size 0 (510k cleared)SMITH & NEPHEW PLC

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

    full page →fda device 510k ↗
    $ANGO13.82-2.81%
    $SNN29.81-1.00%
    $FRTRY
    $MDCE0.00020.00%
    $BSX51.83+0.27%