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calendar

81 catalysts · 3,086 8k filing · 576 earnings · 203 grant · 172 phase 2 completion · 163 approval · 133 drug shortage

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2026-08-10: 0 catalysts2026-08-11: 57 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: 9 catalysts2026-11-03: 18 catalysts2026-11-04: 22 catalysts2026-11-05: 37 catalysts2026-11-06: 2 catalysts2026-11-07: 0 catalysts2026-11-08: 0 catalysts
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type: device 510k×from 2026-04-06×clear all
type
  • 8k filing3,086
  • earnings576
  • grant203
  • phase 2 completion172
  • approval163
  • drug shortage133
device 510k
81
  • phase 1 completion73
  • phase 2 initiation62
  • recall52
  • therapy area

    no tagged catalysts yet

    Week of Apr 6, 2026

    50
    ›Apr 6, 2026device 510k128d agoUzinmedicare Co., Ltd. — SPECTRA Wearable 2 (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 6, 2026device 510k128d agoVirility Medical , Ltd. — in2 Smart (in2S) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 6, 2026device 510k128d agoFujifilm Corporation — APERTO Lucent MRI System (510k cleared)Fujifilm Holdings Corp

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

    full page →fda device 510k ↗
    ›Apr 6, 2026device 510k128d agoEsaote, S.p.A. — 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 6, 2026device 510k128d agoRicoh 3D For Healthcare, LLC — Ricoh 3D for Healthcare Bolus (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 6, 2026device 510k128d agoZoll Respicardia, Inc. — VANES Delivery System (VDS) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 6, 2026device 510k128d agoShenzhen Mindray Bio-Medical Electronics Co., Ltd. — SV70 Ventilator (SV70) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 6, 2026device 510k128d agoSmith & Nephew, Inc. — AETOS Shoulder System - CONCELOC Glenoids (510k cleared)SMITH & NEPHEW PLC

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

    full page →fda device 510k ↗
    ›Apr 6, 2026device 510k128d agoZhuhai Pusen Medical Technology Co., Ltd. — ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250) (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Apr 6, 2026device 510k128d agoAidite (Qinhuangdao) Technology Co., Ltd. — Light-curing Coloring Materials (ALCM) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 6, 2026device 510k128d agoHironic Co., Ltd. — SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 6, 2026device 510k128d agoYAMAHACHI DENTAL MFG., Co. — GLOSSY COAT (15ML) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 6, 2026device 510k128d agoProsomnus Sleep Technologies — ProSomnus RPMO2 OSA Device (RPMO2 OSA) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 7, 2026device 510k127d agoHangzhou Tappa Medical Technology Co., Ltd. — Warming System (510k cleared)Guangzhou Dazhou Biomedical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Apr 7, 2026device 510k127d agoZhejiang shuyou Surgical Instrument Co., Ltd. — Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 7, 2026device 510k127d agoRoche Diagnostics — Elecsys Anti-HAV IgM (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 7, 2026device 510k127d agoBelkin Vision, Ltd. — Voyager DSLT (430840610) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 7, 2026device 510k127d agoRoche Diagnostics — Elecsys Anti-HBc II (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 7, 2026device 510k127d agoRoche Diagnostics — Elecsys Anti-HBc IgM (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 7, 2026device 510k127d agoInnovaCorium, Inc. — IWD-Gel™ (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 7, 2026device 510k127d agoBasic Medical Technology, Inc. — Powder Free Synthetic Vinyl Exam Gloves (Blue, Black) (510k cleared)Medical Care Technologies Inc.

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

    full page →fda device 510k ↗
    ›Apr 7, 2026device 510k127d agoShenzhen Root Innovation Technology Co., Ltd. — Momcozy Wearable Breast Pump (S9 Pro, S9 Pro-A, S9 Pro-B, S9 Pro-C, S9 Pro-D, S9 ProY-A, S9 ProY-B, S9 ProY-C, S12 Pro, S12 Pro-A, S12 Pro-B, S12 Pro-C, S12 Pro-D, S12 ProY-A, S12 ProY-B, S12 ProY-C) (510k cleared)Hang Feng Technology Innovation Co., Ltd.

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

    full page →fda device 510k ↗
    ›Apr 7, 2026device 510k127d agoBeijing OrionStar Technology Co., Ltd. — Power Wheelchair (OS-R-M01S) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 7, 2026device 510k127d agoShanghai MicroPort Medical (Group) Co., Ltd. — Firefighter™ Pro PTCA Balloon Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 7, 2026device 510k127d agoAnumana, Inc. — ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 7, 2026device 510k127d agoCenterPoint Systems, LLC — AuST Steerable Sheath (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 7, 2026device 510k127d agoCogentix Medical, Inc. — PrimeSight UltraView System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 8, 2026device 510k126d 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 510k126d agoResmed Corp — myAir (510k cleared)RESMED INC

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

    full page →fda device 510k ↗
    ›Apr 8, 2026device 510k126d 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 510k126d 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 510k126d 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 510k126d 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 510k126d 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 510k126d 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 510k126d 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 510k126d 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 510k126d 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 510k126d 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 510k126d 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 510k126d 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 510k125d 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 510k125d agoCheckcells, Inc. — Seaman Pro/Seaman (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 9, 2026device 510k125d 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 510k125d agoZest Anchors, LLC — LOCATOR® Angled Abutment (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 9, 2026device 510k125d 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 510k125d 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 510k125d agoKLISBio S.r.l. — SILKBridge (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 9, 2026device 510k125d agoSpineart SA — SPINEART Navigation Instrument System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 9, 2026device 510k125d 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 ↗
    ← prev
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    $STE238.91+0.61%
    $TNON0.2832-3.11%
    $RMD220.38+5.13%
    $MODD4.6400+0.87%
    $SNN30.11+0.12%
    $STE238.91+0.61%
    $BSX50.46+2.33%
    $FOFO3.0000+2.39%
    $FRTRY
    $MDCE0.00020.00%
    $FOFO3.0000+2.39%