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calendar

54 catalysts · 3,045 8k filing · 572 earnings · 172 phase 2 completion · 169 grant · 133 drug shortage · 121 approval

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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 2026-04-08×clear all
type
  • 8k filing3,045
  • earnings572
  • phase 2 completion172
  • grant169
  • drug shortage133
  • approval121
phase 1 completion
73
  • phase 2 initiation62
  • device 510k54
  • recall51
  • therapy area

    no tagged catalysts yet

    Week of Apr 6, 2026

    50
    ›Apr 8, 2026device 510k125d agoSTERIS Corporation — SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 (510k cleared)STERIS plc

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

    full page →fda device 510k ↗
    ›Apr 8, 2026device 510k125d agoResmed Corp — myAir (510k cleared)RESMED INC

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

    full page →fda device 510k ↗
    ›Apr 8, 2026device 510k125d agoHangzhou AGS MedTech Co., Ltd. — Hemoclip (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 8, 2026device 510k125d agoChangzhou Sifary Medical Technology Co., Ltd. — Apex Locator (FindPex) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 8, 2026device 510k125d 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 510k125d 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 510k125d 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 510k125d 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 510k125d 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 510k125d 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 510k125d 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 510k125d 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 510k125d 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 510k125d 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 510k124d 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 510k124d agoCheckcells, Inc. — Seaman Pro/Seaman (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 9, 2026device 510k124d 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 510k124d agoZest Anchors, LLC — LOCATOR® Angled Abutment (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 9, 2026device 510k124d 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 510k124d 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 510k124d agoKLISBio S.r.l. — SILKBridge (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 9, 2026device 510k124d agoSpineart SA — SPINEART Navigation Instrument System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 9, 2026device 510k124d 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 510k124d 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 510k124d 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 510k124d 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 510k123d agoAscblue Corporation — Ascblue (8010) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 10, 2026device 510k123d 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 510k123d 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 510k123d 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 510k123d 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 510k123d 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 510k123d 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 510k123d 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 510k123d agoRelu BV — Relu Cloud (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 10, 2026device 510k123d 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 510k123d 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 510k123d 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 510k123d agoShenB Co., Ltd. — Diacore (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 10, 2026device 510k123d 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 510k123d 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 510k123d agoShaeferh, LLC — ShaeferH (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 10, 2026device 510k123d 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 510k123d 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 510k123d agoSiemens Healthcare GmbH — syngo Dynamics (VA41F) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 10, 2026device 510k123d 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 510k123d 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 510k123d 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 510k123d agoCognifisense, Inc. — VRNT (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 10, 2026device 510k123d agoSiemens Healthcare GmbH — AI-Rad Companion Organs RT (510k cleared)

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

    full page →fda device 510k ↗
    ← prev
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    $STE238.91+0.61%
    $FRTRY
    $TNON0.2832-3.11%
    $FOFO3.0000+2.39%
    $BSX50.46+2.33%
    $VANI1.6000+18.52%
    $STE238.91+0.61%
    $BDX179.63+1.57%
    $RMD220.38+5.13%
    $MODD4.6400+0.87%
    $BDX179.63+1.57%