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calendar

116 catalysts · 3,045 8k filing · 571 earnings · 249 grant · 179 approval · 172 phase 2 completion · 133 drug shortage

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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: 20 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 2026-04-02×clear all
type
  • 8k filing3,045
  • earnings571
  • grant249
  • approval179
  • phase 2 completion172
  • drug shortage133
device 510k
116
  • phase 1 completion73
  • phase 2 initiation62
  • device pma59
  • therapy area

    no tagged catalysts yet

    Week of Mar 30, 2026

    35
    ›Apr 2, 2026device 510k131d agoMedical Brands Laboratories B.V. — Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 2, 2026device 510k131d agoIcu Medical, Inc. — LifeShield Infusion Safety Software Suite (510k cleared)ICU MEDICAL INC/DE

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

    full page →fda device 510k ↗
    ›Apr 2, 2026device 510k131d agoShalby Advanced Technologies, Inc. Dba Consensus Orthopedics — Tahoe Unicondylar Knee System with TiNbN Overcoat (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 2, 2026device 510k131d agoBeijing L&Z Medical Technology Development Co., Ltd. — Disposable Infusion Bag for Parenteral Nutrition (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 2, 2026device 510k131d agoVerge Medical, Inc. — FLASH Flex™ Aorto-Ostial Angioplasty System (510k cleared)VYCOR MEDICAL INC

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

    full page →fda device 510k ↗
    ›Apr 2, 2026device 510k131d agoChengdu Cryo-Push Medical Technology Co.,Ltd — Cryopush Cold Compression Device (A02-P-001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 2, 2026device 510k131d agoEl.En S.P.A. — SPECCHIO (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 2, 2026device 510k131d agoMiracell Co., Ltd. — SMART M-CELL PRP Concentration System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 2, 2026device 510k131d agoBecton, Dickinson and Company — Onclarity™ Self-Collection Kit (510k cleared)BECTON DICKINSON & CO

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

    full page →fda device 510k ↗
    ›Apr 2, 2026device 510k131d agoMiracell Co., Ltd. — SMART M-CELL Bone Marrow Concentration System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 2, 2026device 510k131d agoXuzhou Yongkang Electronic Science Technology Co., Ltd. — Wireless Probe Type Ultrasound Scanner (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 2, 2026device 510k131d agoJeil Medical Corporation — Leforte MMF System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 2, 2026device 510k131d agoBecton Dickinson Infusion Therapy Systems, Inc. — BD Insyte™ IV Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 2, 2026device 510k131d agoRoche Diagnostics — Tina-quant Cardiac high sensitivity CRP III (510k cleared)Dawn Sea Therapeutics

    Product code: NQD. Advisory committee: Immunology. Type: Traditional

    full page →fda device 510k ↗
    ›Apr 2, 2026device 510k131d agoGenoray Co., Ltd. — BELLIGER ACE (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 3, 2026device 510k130d agoRadformation, Inc. — ClearCheck (RADCC V2.7) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 3, 2026device 510k130d agoNewpong Co., Ltd. — LSSA (NP-200) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 3, 2026device 510k130d agoCixi Ruihong Electric Appliance Co., Ltd. — Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 3, 2026device 510k130d agoMED-EL Elektromedizinische Geräte GmbH — mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x 3.75 mm) (58719); mWING Stapes Prosthesis (0.4 x 4.00 mm) (58721); mWING Stapes Prosthesis (0.4 x 4.25 mm) (58723); mWING Stapes Prosthesis (0.4 x 4.50 mm) (58725); mWING Stapes Prosthesis (0.4 x 4.75 mm) (58727); mWING Stapes Prosthesis (0.4 x 5.00 mm) (58729); mWING Stapes Prosthesis (0.4 x 5.25 mm) (58731); mWING Stapes Prosthesis (0.4 x 5.50 mm) (58733); mWING Stapes Prosthesis (0.5 x 3.50 mm) (58735); (510k cleared)

    Product code: ETB. Advisory committee: Ear, Nose, Throat. Type: Special

    full page →fda device 510k ↗
    ›Apr 3, 2026device 510k130d agoZhejiang Soudon Medical Technology Co., Ltd. — Disposable Stone Extraction Basket (510k cleared)Zhejiang Xinkanghe Biomedical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Apr 3, 2026device 510k130d agoTW Medical — Life Saving Tourniquet (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 3, 2026device 510k130d agoMagentiq Eye, Ltd. — MAGENTIQ-COLO (ME-APDS) (510k cleared)

    Product code: QNP. Advisory committee: Gastroenterology, Urology. Type: Special

    full page →fda device 510k ↗
    ›Apr 3, 2026device 510k130d agoShanghai United Imaging Healthcare Co., Ltd. — uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 3, 2026device 510k130d agoStryker Corporation (Tornier, S.A.S.) — Blueprint Patient-Specific Instrumentation (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 3, 2026device 510k130d agoZhongshan A&J Medical Equipment Co., Ltd. — Electric Wheelchair (AL-208S-063) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 3, 2026device 510k130d agoMED-EL Elektromedizinische Geräte GmbH — mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm) (58671);mGRIP Partial Prosthesis (1.25 mm) (58673);mGRIP Partial Prosthesis (1.50 mm) (58675);mGRIP Partial Prosthesis (1.75 mm) (58677);mGRIP Partial Prosthesis (2.00 mm) (58679);mGRIP Partial Prosthesis (2.25 mm) (58681);mGRIP Partial Prosthesis (2.50 mm) (58683);mGRIP Partial Prosthesis (3.00 mm) (58685);mGRIP Partial Prosthesis (3.50 mm) (58687);mDISC Partial Prosthesis (58850) (510k cleared)

    Product code: ETB. Advisory committee: Ear, Nose, Throat. Type: Special

    full page →fda device 510k ↗
    ›Apr 3, 2026device 510k130d agoEtiometry, Inc. — Etiometry Platform (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 3, 2026device 510k130d agoChengdu Cryo-Push Medical Technology Co.,Ltd — Hot and Cold Compression System (A02-C-032) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 3, 2026device 510k130d agoTyber Medical, LLC — Tyber Medical Trauma Screw (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 3, 2026device 510k130d agoCeribell, Inc. — Ceribell Brain Monitor Headband (510k cleared)Ceribell, Inc.

    Product code: GXY. Advisory committee: Neurology. Type: Abbreviated

    full page →fda device 510k ↗
    ›Apr 3, 2026device 510k130d agoS.M.A.I.O — KHEIRON® Spinal Fixation System, including patient specific K-ROD (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 3, 2026device 510k130d agoMirco-Tech (Nanjing) Co., Ltd. — Single-use Video Scope; PB Digital Controller (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 3, 2026device 510k130d agoHyalex Orthopaedics, Inc. — HYALEX® MTP Hemiarthroplasty Implant (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 3, 2026device 510k130d agoMED-EL Elektromedizinische Geräte GmbH — mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm) (58691); mGRIP Total Prosthesis (3.50 mm) (58693); mGRIP Total Prosthesis (3.75 mm) (58695); mGRIP Total Prosthesis (4.00 mm) (58697); mGRIP Total Prosthesis (4.25 mm) (58699); mGRIP Total Prosthesis (4.50 mm) (58701); mGRIP Total Prosthesis (4.75 mm) (58703); mGRIP Total Prosthesis (5.00 mm) (58705); mGRIP Total Prosthesis (5.50 mm) (58707); mGRIP Total Prosthesis (6.00 mm) (58709); mGRIP Total Prosthesis (6.50 (510k cleared)

    Product code: ETA. Advisory committee: Ear, Nose, Throat. Type: Special

    full page →fda device 510k ↗
    ›Apr 3, 2026device 510k130d agoAutomated Imaging Diagnostics, LLC — neuropacs (510k cleared)

    Product code: SHO. Advisory committee: Neurology. Type: Direct

    full page →fda device 510k ↗

    Week of Apr 6, 2026

    15
    ›Apr 6, 2026device 510k127d 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 510k
    ← prev
    page 1 of 3
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    127d ago
    Virility Medical , Ltd. — in2 Smart (in2S) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 6, 2026device 510k127d 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 510k127d 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 510k127d 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 510k127d 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 510k127d 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 510k127d 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 510k127d 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 510k127d 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 510k127d 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 510k127d 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 510k127d 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 510k126d 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 510k126d 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 ↗
    $VYCO0.06600.00%
    $BDX179.63+1.57%
    $ICUI182.42-1.16%
    $CBLL19.55-2.25%
    $SNN30.08-0.10%