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5,000 catalysts · 18,987 approval · 5,000 device 510k · 4,970 phase readout · 4,728 grant · 2,443 8k filing · 2,000 device pma

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2026-07-27: 0 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: 1 catalyst2026-09-02: 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 catalysts2026-10-19: 0 catalysts2026-10-20: 1 catalyst2026-10-21: 0 catalysts2026-10-22: 1 catalyst2026-10-23: 0 catalysts2026-10-24: 0 catalysts2026-10-25: 0 catalysts
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type: device 510k×clear all
type
  • approval18,987
  • device 510k5,000
  • phase readout4,970
  • grant4,728
  • 8k filing2,443
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • earnings296
  • therapy area

    no tagged catalysts yet

    Week of Apr 7, 2025

    50
    ›Apr 8, 2025device 510k476d agoGuard Medical, Inc. — NPseal (510k cleared)Picard Medical, Inc.

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

    full page →fda device 510k ↗
    ›Apr 8, 2025device 510k476d agoAnhui Longway Medical Technology Co., Ltd. — Electric Wheelchair (LW01301A07) (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Apr 8, 2025device 510k476d agoGlobalcare Medical Technology Co., Ltd. — Globalcare Blood Pressure Monitor (GUS610) (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Apr 8, 2025device 510k476d agoShenzhen Ulike Smart Electronics Co., Ltd. — Jmoon Conductive Gel (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 8, 2025device 510k476d agoLuxCreo, Inc. — LuxCreo Clear Aligner System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 8, 2025device 510k476d agoGlobal Protection Corp. — ONE Nitrile Condom (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 8, 2025device 510k476d agoSelio Medical Limited — Pre-B Seal Lung Biopsy Plug System - 15cm Model (FG0001); Pre-B Seal Lung Biopsy Plug System - 16cm Model (FG0002); Pre-B Seal Lung Biopsy Plug System - 20cm Model (FG0003) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 9, 2025device 510k475d agoLife Spine, Inc. — ProLift Expandable Spacer System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 9, 2025device 510k475d agoBecton Dickinson Inc. (Bd) — CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System (510k cleared)BECTON DICKINSON & CO

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

    full page →fda device 510k ↗
    ›Apr 9, 2025device 510k475d agoFaceheart Corp. — FaceHeart Vitals Software Development Kit (FH vitals SDK-RR) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 9, 2025device 510k475d agoTranstimulation Research, Inc. — Patch-TEA (Model TRI-21) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 9, 2025device 510k475d agoIntegra LifeSciences Corporation — AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80) (510k cleared)INTEGRA LIFESCIENCES HOLDINGS CORP

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

    full page →fda device 510k ↗
    ›Apr 9, 2025device 510k475d agoCeribell, Inc. — Ceribell Seizure Detection Software (510k cleared)Ceribell, Inc.

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

    full page →fda device 510k ↗
    ›Apr 9, 2025device 510k475d agoLuminopia, Inc. — Luminopia (510k cleared)

    Product code: QQU. Advisory committee: Ophthalmic. Type: Traditional

    full page →fda device 510k ↗
    ›Apr 9, 2025device 510k475d agoDavol, Inc. — Bard Soft Mesh; Bard Soft Mesh Pre-Shaped (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 9, 2025device 510k475d agoDexcom, Inc. — Dexcom G7 15 Day Continuous Glucose Monitoring System (510k cleared)DEXCOM INC

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

    full page →fda device 510k ↗
    ›Apr 9, 2025device 510k475d agoHolberg Eeg AS — autoSCORE (V 2.0.0) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 9, 2025device 510k475d agoActive Protective Technologies, Inc. — Tango® Belt (Model SAS-001-01 (XS); Model SAS-001-02 (S); Model SAS-001-03 (M); Model SAS-001-04 (L); Model SAS-001-05 (XL)) (510k cleared)PROCORE TECHNOLOGIES, INC.

    Product code: SEC. Advisory committee: Physical Medicine. Type: Direct

    full page →fda device 510k ↗
    ›Apr 10, 2025device 510k474d agoBrain Electrophysiology Laboratory Company, LLC — NEAT 001 (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 10, 2025device 510k474d agoKyocera Medical Technologies Inc. (KMTI) — Skyway Anterior Cervical Plate System (510k cleared)Medical Care Technologies Inc.

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

    full page →fda device 510k ↗
    ›Apr 10, 2025device 510k474d agoKyocera Medical Technologies, Inc. — Tesera-k SC System (510k cleared)Medical Care Technologies Inc.

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

    full page →fda device 510k ↗
    ›Apr 10, 2025device 510k474d agoDonnevie Medical Technology (Shanghai) Co. , Ltd. — Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 10, 2025device 510k474d agoCanon Medical Informatics, Inc. — Vitrea CT VScore (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 10, 2025device 510k474d agoOrthofix Srl — FitboneTM Trochanteric (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 10, 2025device 510k474d agoVizionfocus, Inc. — Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color) (510k cleared)

    Product code: LPL. Advisory committee: Ophthalmic. Type: Traditional

    full page →fda device 510k ↗
    ›Apr 10, 2025device 510k474d agoTriMed, Inc. — TriMed® Compression Screws (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 10, 2025device 510k474d agoSiemens Medical Solutions USA, Inc. — syngo.CT LVO Detection (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 10, 2025device 510k474d 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 ↗
    ›Apr 10, 2025device 510k474d agoKyocera Medical Technologies, Inc. — Initia T3 Acetabular Hemispherical Shell System (510k cleared)Medical Care Technologies Inc.

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

    full page →fda device 510k ↗
    ›Apr 10, 2025device 510k474d agoJiangsu Ruifuda Medical Device Co., Ltd. — Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 10, 2025device 510k474d agoCuremetrix, Inc. — cmAngio® (V1.6) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 10, 2025device 510k474d agoAtriCure, Inc. — cryoICE cryoXT cryoablation probe (cryoXT) (510k cleared)AtriCure, Inc.

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

    full page →fda device 510k ↗
    ›Apr 10, 2025device 510k474d agoPremium Plus (Dongguan) Limited — LED Curing Light (C01-X, C02-X) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 10, 2025device 510k474d agoChangzhou Xin Neng Yuan Medical Stapler Co.,Ltd — XNY Disposable Gastric Calibration Tube (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 11, 2025device 510k473d agoFoshan Coxo Medical Instrument Co., Ltd. — LED Curing Lights (DB686 HALO) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 11, 2025device 510k473d agoNelson Environmental Technologies, Inc. — Chlorine Sentinel II (510k cleared)BION ENVIRONMENTAL TECHNOLOGIES INC

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

    full page →fda device 510k ↗
    ›Apr 11, 2025device 510k473d agoOncospace, Inc. — Oncospace (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 11, 2025device 510k473d agoSmartsurgN, Inc. — AirSurgN Insufflator (10030/AirSurgN) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 11, 2025device 510k473d agoShenzhen Trious Medical Technology Co., Ltd. — Disposable ureteral access sheath (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Apr 11, 2025device 510k473d agoAlma Lasers, Inc. — Alma Harmony (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 11, 2025device 510k473d agoFujifilm Corporation — FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R (510k cleared)Fujifilm Holdings Corp

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

    full page →fda device 510k ↗
    ›Apr 11, 2025device 510k473d agoXelite Biomed , Ltd. — XeliteMed VertehighFix High Viscosity Spinal Bone Cement System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 11, 2025device 510k473d agoCognoa, Inc. — Canvas Dx (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 11, 2025device 510k473d agoGuilin Aesthedent Medical Instruments Co., Ltd. — Dental Implant Unit (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 11, 2025device 510k473d agoDentsply Sirona — Atlantis® Abutments in Titanium (510k cleared)DENTSPLY SIRONA Inc.

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

    full page →fda device 510k ↗
    ›Apr 11, 2025device 510k473d agoShenzhen Vivolight Medical Device & Technology Co., Ltd. — Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 11, 2025device 510k473d agoKlaxon-Mobility GmbH — KLAXON (TWIST); KLAXON (TWIST R) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 11, 2025device 510k473d agoCooperSurgical, Inc. — CooperSurgical Milex® Pessaries (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 11, 2025device 510k473d agoAidite (Qinhuangdao) Technology Co., Ltd. — Dental Zirconia Ceramic (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 11, 2025device 510k473d agoAsiga Pty, Ltd. — Asiga DentaBASE (510k cleared)

    Product code: EBI. Advisory committee: Dental. Type: Abbreviated

    full page →fda device 510k ↗
    ← prev
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    $PMI0.1821-4.66%
    $BDX158.92+1.64%
    $PCOR
    $DXCM73.37+2.56%
    $CBLL19.55-2.25%
    $IART19.53-1.31%
    $MDCE0.00020.00%
    $MDCE0.00020.00%
    $MDCE0.00020.00%
    $ATRC
    $BNET
    $XRAY13.02+0.70%