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5,000 catalysts · 18,987 approval · 5,000 device 510k · 4,728 grant · 4,686 phase readout · 2,347 8k filing · 2,000 device pma

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2026-07-20: 0 catalysts2026-07-21: 0 catalysts2026-07-22: 14 catalysts2026-07-23: 2 catalysts2026-07-24: 1 catalyst2026-07-25: 0 catalysts2026-07-26: 0 catalysts2026-07-27: 2 catalysts2026-07-28: 4 catalysts2026-07-29: 12 catalysts2026-07-30: 12 catalysts2026-07-31: 3 catalysts2026-08-01: 0 catalysts2026-08-02: 0 catalysts2026-08-03: 4 catalysts2026-08-04: 12 catalysts2026-08-05: 14 catalysts2026-08-06: 10 catalysts2026-08-07: 1 catalyst2026-08-08: 0 catalysts2026-08-09: 0 catalysts2026-08-10: 1 catalyst2026-08-11: 1 catalyst2026-08-12: 1 catalyst2026-08-13: 0 catalysts2026-08-14: 0 catalysts2026-08-15: 0 catalysts2026-08-16: 0 catalysts2026-08-17: 0 catalysts2026-08-18: 1 catalyst2026-08-19: 0 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: 0 catalysts2026-08-27: 0 catalysts2026-08-28: 0 catalysts2026-08-29: 0 catalysts2026-08-30: 0 catalysts2026-08-31: 0 catalysts2026-09-01: 0 catalysts2026-09-02: 0 catalysts2026-09-03: 0 catalysts2026-09-04: 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: 0 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: 0 catalysts2026-10-09: 0 catalysts2026-10-10: 0 catalysts2026-10-11: 0 catalysts2026-10-12: 0 catalysts2026-10-13: 0 catalysts2026-10-14: 0 catalysts2026-10-15: 0 catalysts2026-10-16: 0 catalysts2026-10-17: 0 catalysts2026-10-18: 0 catalysts
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type: device 510k×clear all
type
  • approval18,987
  • device 510k5,000
  • grant4,728
  • phase readout4,686
  • 8k filing2,347
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • earnings292
  • therapy area

    no tagged catalysts yet

    Week of Oct 7, 2024

    13
    ›Oct 11, 2024device 510k650d agoSiemens Medical Solutions USA, Inc. — syngo Application Software (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 11, 2024device 510k650d agoDongguan Boyuan Intelligent Technology Co.,Ltd — LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 11, 2024device 510k650d agoPermantis Public Health — PPH Saliva Collection Kit (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 11, 2024device 510k650d agoSTERIS Corporation — DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) (510k cleared)STERIS plc

    Product code: ODC. Advisory committee: Gastroenterology, Urology. Type: Special

    full page →fda device 510k ↗
    ›Oct 11, 2024device 510k650d agoOrtho Development Corp. — Legend® Acetabular Shell (510k cleared)DeFi Development Corp.

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

    full page →fda device 510k ↗
    ›Oct 11, 2024device 510k650d agoBelun Technology Company Limited — Belun Ring BLR-200 (BLR-200) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 11, 2024device 510k650d agoCmr Surgical Limited — Versius Surgical System (510k cleared)

    Product code: SCV. Advisory committee: General, Plastic Surgery. Type: Direct

    full page →fda device 510k ↗
    ›Oct 11, 2024device 510k650d agoSamsung Medison Co., Ltd. — HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 11, 2024device 510k650d agoPeters Surgical — Monotime and Optime R (510k cleared)

    Product code: GAM. Advisory committee: General, Plastic Surgery. Type: Abbreviated

    full page →fda device 510k ↗
    ›Oct 11, 2024device 510k650d agoZhejiang Innuovo Rehabilitation Devices Co.,Ltd — Mobility Scooter (N3473) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 11, 2024device 510k650d agoQpix Solutions, Inc. — X Sensor (Model: IOS-A15IF, HDI-15DGF) (510k cleared)UL Solutions Inc.

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

    full page →fda device 510k ↗
    ›Oct 11, 2024device 510k650d agoCenterline Biomedical, Inc. — Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System (IOPS®) (Guidewire Handle) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 12, 2024device 510k649d agoNb Medical Company Limited — NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs) (510k cleared)

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

    full page →fda device 510k ↗

    Week of Oct 14, 2024

    37
    ›Oct 15, 2024device 510k646d agoCircle Cardiovascular Imaging, Inc. — cvi42 Software Application (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 15, 2024device 510k
    ← prev
    page 4 of 100
    next →
    646d ago
    Scivita Medical Technology Co., Ltd. — Single-use Extraction Baskets (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Oct 15, 2024device 510k646d agoDen-Mat Holdings, LLC — DenMat Bulk Fill Composite (510k cleared)DCFC Holdings, LLC

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

    full page →fda device 510k ↗
    ›Oct 15, 2024device 510k646d agoShenzhen Piocreat 3D Technology Co., Ltd. — Denture Base Resin (PN-Denture (Red, White)) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 15, 2024device 510k646d agoInari Medical, Inc. — Artix™ MT; Artix™ Thin-Walled Thrombectomy Sheath (510k cleared)Mobia Medical, Inc.

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

    full page →fda device 510k ↗
    ›Oct 15, 2024device 510k646d agoTautona Group — TauTona Pneumoperitoneum Assist Device (TPAD) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 15, 2024device 510k646d agoMediimg Corporation — VINT (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 15, 2024device 510k646d agoCure Point Therapeutics, Inc. — SIRONA 100 Therapy Laser System (OEM's Model EVANLAS) (510k cleared)Checkpoint Therapeutics Inc

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

    full page →fda device 510k ↗
    ›Oct 15, 2024device 510k646d agoSteritec Products Mfg. (A Getinge Group Company) — Getinge Assured MI Steam Migrating Integrator (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 16, 2024device 510k645d agoStryker Instruments — Stryker Steri-Shield 8 Surgical Hoods and Togas (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 16, 2024device 510k645d agoAugmedics, Ltd. — xvision Spine System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 16, 2024device 510k645d agoAbbott Laboratories Diagnostics Division — Alkaline Phosphatase (510k cleared)ABBOTT LABORATORIES

    Product code: CJE. Advisory committee: Clinical Chemistry. Type: Special

    full page →fda device 510k ↗
    ›Oct 16, 2024device 510k645d agoCerenovus, Inc. — CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing Set (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 16, 2024device 510k645d agoLi Medical Corporation , Ltd. — RELIEEV Uterine Manipulator Injector (CUMI 5.0) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 16, 2024device 510k645d agoCerenovus, Inc. — CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 16, 2024device 510k645d agoShenzhen Safesecure Medical Infection Control Tech Co. , Ltd. — Safe Secure Sterilization Pouches and Rolls (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 16, 2024device 510k645d agoPeytant Solutions, Inc. — AMStent® Tracheobronchial Covered Stent System (510k cleared)PDF SOLUTIONS INC

    Product code: SDB. Advisory committee: Anesthesiology. Type: Direct

    full page →fda device 510k ↗
    ›Oct 16, 2024device 510k645d agoDualams, Inc., Dba Airkor — UltraEzAir® (UEA1A) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 16, 2024device 510k645d agoShenzhen Hbcare Technology Co.,Ltd — Elecrtronic Blood Pressure Monitor (BP-201, BP-202, BP-203, BP-204, BP-205, BP-206) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Oct 16, 2024device 510k645d agoJLK, Inc. — JLK-CTP (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 16, 2024device 510k645d agoVy Spine, LLC — Vy Spine™ VyLam™ Laminoplasty System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 16, 2024device 510k645d agoEdwards Lifesciences — Cerebral Autoregulation Index (CAI) Algorithm (510k cleared)Edwards Lifesciences Corp

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

    full page →fda device 510k ↗
    ›Oct 16, 2024device 510k645d agoVarian Medical Systems, Inc. — ONCOZENE Microspheres (510k cleared)MERIT MEDICAL SYSTEMS INC

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

    full page →fda device 510k ↗
    ›Oct 16, 2024device 510k645d agoAmbu A/S — Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection); Ambu® aBox™ 2 (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 16, 2024device 510k645d agoKunshan Hi-Fortune Health Products Co., Ltd. — Electrically powered wheelchair (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 17, 2024device 510k644d agoHager& Meisinger GmbH — MP Pin flat without thread (36BMP000020/MP20) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 17, 2024device 510k644d agoAstura Medical — EGPS Navigated Instruments (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 17, 2024device 510k644d agoEpitel, Inc. — REMI-AI Rapid Detection Module (REMI-AI RDM) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 17, 2024device 510k644d agoBaui Biotech Co., Ltd. — NOVA Minimally Invasive System (510k cleared)Oneness Biotech Co Ltd

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

    full page →fda device 510k ↗
    ›Oct 17, 2024device 510k644d agoMedical Graphics Corporation — Ascent Cardiorespiratory Diagnostic Software (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 17, 2024device 510k644d agoKunshan Hi-Fortune Health Products Co., Ltd. — Electrically powered wheelchair (HP202) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 17, 2024device 510k644d agoHidroxa Medical AB — Hidroxa SE30 (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 17, 2024device 510k644d agoPerfuze, Ltd. — Zipline Access Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 17, 2024device 510k644d agoGe Medical Systems, LLC — SIGNA MAGNUS (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 17, 2024device 510k644d agoShenzhen Huaruibo Electric Appliances Co., Ltd. — IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 17, 2024device 510k644d agoImbed Biosciences — Microlyte Ag/Lidocaine (510k cleared)Sustained Therapeutics Inc

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

    full page →fda device 510k ↗
    ›Oct 17, 2024device 510k644d agoFimilla (Shanghai) Maternity & Baby Articles Co., Ltd. — Electric Breast Pump (F5055) (510k cleared)

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

    full page →fda device 510k ↗
    $ULS
    $STE211.75-1.27%
    $DFUKF
    $ABT100.53+0.87%
    $MOBI
    $FRTRY
    $EW91.33-2.47%
    $PDFS
    $DCFBS
    $MMSI73.48-2.25%