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5,000 catalysts · 18,987 approval · 5,811 phase readout · 5,000 device 510k · 4,728 grant · 2,984 8k filing · 2,000 device pma

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2026-08-03: 0 catalysts2026-08-04: 0 catalysts2026-08-05: 0 catalysts2026-08-06: 0 catalysts2026-08-07: 0 catalysts2026-08-08: 0 catalysts2026-08-09: 0 catalysts2026-08-10: 14 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: 11 catalysts2026-10-29: 20 catalysts2026-10-30: 4 catalysts2026-10-31: 0 catalysts2026-11-01: 0 catalysts
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type: device 510k×clear all
type
  • approval18,987
  • phase readout5,811
  • device 510k5,000
  • grant4,728
  • 8k filing2,984
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • earnings572
  • therapy area

    no tagged catalysts yet

    Week of Apr 6, 2026

    50
    ›Apr 8, 2026device 510k123d agoSTERIS Corporation — Celerity 5 HP Biological Indicator (LCB052) (510k cleared)STERIS plc

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

    full page →fda device 510k ↗
    ›Apr 8, 2026device 510k123d agoSuzhou Shenyun Medical Equipment Co., Ltd. — Shogun Axis™ Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 8, 2026device 510k123d agoScopix , Ltd. — TL-10 Laparoscopic Scope Cleaner (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 8, 2026device 510k123d agoTenon Medical — CATAMARAN™ SI Joint Fusion System (510k cleared)Tenon Medical, Inc.

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

    full page →fda device 510k ↗
    ›Apr 8, 2026device 510k123d agoModular Medical — Pivot Insulin Delivery System (510k cleared)Modular Medical, Inc.

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

    full page →fda device 510k ↗
    ›Apr 8, 2026device 510k123d agoMacroLux Medical Technology Co., Ltd. — LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG) (510k cleared)NewBay Medical Technology Co Ltd

    Product code: EOQ. Advisory committee: Ear, Nose, Throat. Type: Traditional

    full page →fda device 510k ↗
    ›Apr 8, 2026device 510k123d agoShenzhen TPH Technology Co., Ltd. — Wearable Breast Pump (Model S21A) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Apr 8, 2026device 510k123d agoBoston Scientific — OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coronary Imaging Catheter (H74939352040); OptiCross 6 HD Coronary Imaging Catheter (H74939354080); OptiCross Coronary Imaging Catheter (Bagless) (H749518130); OptiCross 6 Coronary Imaging Catheter (Bagless) (H7495181360); OptiCross HD Coronary Imaging Catheter (Bagless) (H74939352050); OptiCross 6 HD Coronary Imaging Catheter (Bagless) (H74939354090) (510k cleared)BOSTON SCIENTIFIC CORP

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

    full page →fda device 510k ↗
    ›Apr 8, 2026device 510k123d agoCMT Health PTE., Ltd. — Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 8, 2026device 510k123d agoShenzhen Root Innovation Technology Co., Ltd. — Momcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y-A, BP137Y-B, BP141, BP141-A, BP141-B, BP141-C, BP141-D) (510k cleared)Hang Feng Technology Innovation Co., Ltd.

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

    full page →fda device 510k ↗
    ›Apr 9, 2026device 510k122d agoRay Co., Ltd. — RCT800 (510k cleared)Ray Therapeutics Inc

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

    full page →fda device 510k ↗
    ›Apr 9, 2026device 510k122d agoCheckcells, Inc. — Seaman Pro/Seaman (510k cleared)

    Product code: POV. Advisory committee: Hematology. Type: Traditional

    full page →fda device 510k ↗
    ›Apr 9, 2026device 510k122d agoInternational Life Sciences — Artelon Convenience Kits (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 9, 2026device 510k122d agoZest Anchors, LLC — LOCATOR® Angled Abutment (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 9, 2026device 510k122d agoCG Bio Co., Ltd. — EASYMADE-TI (510k cleared)3H Bio Co Ltd

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

    full page →fda device 510k ↗
    ›Apr 9, 2026device 510k122d agoMaduro Medical, Inc. — Radical 6F Access Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 9, 2026device 510k122d agoKLISBio S.r.l. — SILKBridge (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 9, 2026device 510k122d agoSpineart SA — SPINEART Navigation Instrument System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 9, 2026device 510k122d agoShanghai Apolo Medical Technology Co., Ltd. — Picosecond Nd:YAG Laser Systems (Model: HS-298) (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Apr 9, 2026device 510k122d agoAnhui Happiness Workshop Instruments Co., Ltd. — Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 9, 2026device 510k122d agoShandong Huge Dental Material Corporation — Eternal Art Porcelain Powders (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 9, 2026device 510k122d agoRivanna Medical, Inc. — Accuro XV (510k cleared)Vivani Medical, Inc.

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

    full page →fda device 510k ↗
    ›Apr 10, 2026device 510k121d agoAscblue Corporation — Ascblue (8010) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 10, 2026device 510k121d agoDk Medical Systems Co., Ltd. — AeroDR TX c02 (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 10, 2026device 510k121d agoPlasma Surgical, Inc. — ARION ARC System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 10, 2026device 510k121d agoSophysa — Pressio 3 Multi-parameter Neuromonitoring System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 10, 2026device 510k121d ago1987 Media Limited — ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size)) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 10, 2026device 510k121d agoOkami Medical, Inc. — LOBO Vascular Occlusion System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 10, 2026device 510k121d ago3Shape TRIOS A/S — TRIOS Dx (R1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 10, 2026device 510k121d agoActis Medical Pty., Ltd. — SMART Osteotomy System (510k cleared)Atticus Medical Pty Ltd

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

    full page →fda device 510k ↗
    ›Apr 10, 2026device 510k121d agoRelu BV — Relu Cloud (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 10, 2026device 510k121d agoUniversity of Utah, Department of Orthopaedics — CoAptix S System (510k cleared)University of Utah

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

    full page →fda device 510k ↗
    ›Apr 10, 2026device 510k121d agoAitewan Biomedical Technology, Inc. — DeepBT Detector-Plus (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 10, 2026device 510k121d agoShanghai Draeger Medical Instrument Co., Ltd. — Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model C, US (2601065); Vista 300 S Non-Inv Model A, US (2602425); Vista 300 S Invasive Model B, US (2602426); Vista 300 S Invasive Model C, US (2602427) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 10, 2026device 510k121d agoShenB Co., Ltd. — Diacore (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 10, 2026device 510k121d agoBecton, Dickinson and Company — BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection Tube (510k cleared)BECTON DICKINSON & CO

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

    full page →fda device 510k ↗
    ›Apr 10, 2026device 510k121d agoOverjet, Inc. — Overjet Iris Intelligent Imaging System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 10, 2026device 510k121d agoShaeferh, LLC — ShaeferH (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 10, 2026device 510k121d agoBecton, Dickinson and Company — BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached Holder (510k cleared)BECTON DICKINSON & CO

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

    full page →fda device 510k ↗
    ›Apr 10, 2026device 510k121d agoCovidien (Part of Medtronic) — Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray Articulating Reloads; Signia™ Small Diameter Reloads (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 10, 2026device 510k121d agoSiemens Healthcare GmbH — syngo Dynamics (VA41F) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 10, 2026device 510k121d agoOrbusNeich Medical (Shenzhen) Co., Ltd. — Teleport Glide Microcatheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 10, 2026device 510k121d agoMedela, LLC — Freestyle Mini Hands-free (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 10, 2026device 510k121d agoCequr SA — CeQur Simplicity™ On-Demand Insulin Delivery System (510k cleared)Shanghai Jiao Tong University

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

    full page →fda device 510k ↗
    ›Apr 10, 2026device 510k121d agoCognifisense, Inc. — VRNT (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 10, 2026device 510k121d agoSiemens Healthcare GmbH — AI-Rad Companion Organs RT (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 10, 2026device 510k121d agoProtaryx Medical, Inc. — Protaryx Transseptal Puncture Device (PTX2-001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 10, 2026device 510k121d agoEximo Medical — Auryon Atherectomy System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 10, 2026device 510k121d agoBelport Company, Inc., Gingi-Pak — Porcelain Etch Gel (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 10, 2026device 510k121d agoRadiometer Medicals Aps — ABL90 FLEX PLUS System, safeCLINITUBES (510k cleared)

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

    full page →fda device 510k ↗
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    $STE237.47+2.45%
    $FRTRY
    $BSX49.31+0.02%
    $MODD4.6400+0.87%
    $TNON0.2832-3.11%
    $FOFO3.0000+2.39%
    $BDX176.86-0.12%
    $BDX176.86-0.12%
    $VANI1.6000+18.52%