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3,305 catalysts · 4,728 grant · 3,305 device 510k · 3,045 8k filing · 2,833 approval · 2,000 device pma · 2,000 device recall

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2026-08-10: 0 catalysts2026-08-11: 16 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: 8 catalysts2026-11-03: 17 catalysts2026-11-04: 22 catalysts2026-11-05: 36 catalysts2026-11-06: 2 catalysts2026-11-07: 0 catalysts2026-11-08: 0 catalysts
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type: device 510k×from 2025-04-08×clear all
type
  • grant4,728
  • device 510k3,305
  • 8k filing3,045
  • approval2,833
  • device pma2,000
  • device recall2,000
device adverse event
1,000
  • recall836
  • earnings579
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Apr 7, 2025

    50
    ›Apr 8, 2025device 510k490d agoBunkerHill Health — BunkerHill BMD (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 8, 2025device 510k490d agoShenzhen Nuon Medical Equipment Co., Ltd. — Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 8, 2025device 510k490d agoIcat Solutions, Ltd. — Horos Mobile (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 8, 2025device 510k490d agoTriMed, Inc. — TriMed Fusion Cup System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 8, 2025device 510k490d agoHangzhou Sightnovo Medical Technology Co., Ltd. — Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 8, 2025device 510k490d 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 510k490d 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 510k490d 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 510k490d 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 510k490d agoLuxCreo, Inc. — LuxCreo Clear Aligner System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 8, 2025device 510k490d 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 510k490d 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 510k489d 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 510k489d 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 510k489d 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 510k489d 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 510k489d 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 510k489d 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 510k489d agoLuminopia, Inc. — Luminopia (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 9, 2025device 510k489d 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 510k489d 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 510k489d 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 510k489d 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 510k488d 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 510k488d 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 510k488d 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 510k488d 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 510k488d 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 510k488d agoOrthofix Srl — FitboneTM Trochanteric (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 10, 2025device 510k488d 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 510k488d agoTriMed, Inc. — TriMed® Compression Screws (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 10, 2025device 510k488d 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 510k488d 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 510k488d 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 510k488d 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 510k488d agoCuremetrix, Inc. — cmAngio® (V1.6) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 10, 2025device 510k488d 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 510k488d 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 510k488d 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 510k487d 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 510k487d 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 510k487d agoOncospace, Inc. — Oncospace (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 11, 2025device 510k487d 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 510k487d 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 510k487d 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 510k487d 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 510k487d 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 510k487d agoCognoa, Inc. — Canvas Dx (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 11, 2025device 510k487d 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 510k487d agoDentsply Sirona — Atlantis® Abutments in Titanium (510k cleared)DENTSPLY SIRONA Inc.

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

    full page →fda device 510k ↗
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    $IART17.07-1.04%
    $DXCM87.65+3.42%
    $PMI0.1821-4.66%
    $CBLL19.55-2.25%
    $PCOR
    $BDX179.63+1.57%
    $ATRC
    $BNET
    $MDCE0.00020.00%
    $XRAY11.66-3.80%
    $MDCE0.00020.00%
    $MDCE0.00020.00%