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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 Mar 30, 2026

    19
    ›Apr 3, 2026device 510k128d 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 510k128d 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 510k128d 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 510k128d 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 510k128d agoTW Medical — Life Saving Tourniquet (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 3, 2026device 510k128d 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 510k128d 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 510k128d 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 510k128d 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 510k128d 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 510k128d agoEtiometry, Inc. — Etiometry Platform (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 3, 2026device 510k128d 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 510k128d 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 510k128d 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 510k128d 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 510k128d 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 510k128d 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 510k128d 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 510k128d 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

    31
    ›Apr 6, 2026device 510k125d 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 99 of 100
    next →
    125d 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 510k125d 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 510k125d 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 510k125d 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 510k125d 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 510k125d 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 510k125d 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 510k125d 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 510k125d 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 510k125d 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 510k125d 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 510k125d 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 510k124d 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 510k124d 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 510k124d agoRoche Diagnostics — Elecsys Anti-HAV IgM (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 7, 2026device 510k124d agoBelkin Vision, Ltd. — Voyager DSLT (430840610) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 7, 2026device 510k124d agoRoche Diagnostics — Elecsys Anti-HBc II (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 7, 2026device 510k124d agoRoche Diagnostics — Elecsys Anti-HBc IgM (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 7, 2026device 510k124d agoInnovaCorium, Inc. — IWD-Gel™ (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 7, 2026device 510k124d 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 510k124d 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 510k124d 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 510k124d 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 510k124d 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 510k124d agoCenterPoint Systems, LLC — AuST Steerable Sheath (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 7, 2026device 510k124d 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 510k123d 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 510k123d agoResmed Corp — myAir (510k cleared)RESMED INC

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

    full page →fda device 510k ↗
    ›Apr 8, 2026device 510k123d 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 510k123d agoChangzhou Sifary Medical Technology Co., Ltd. — Apex Locator (FindPex) (510k cleared)

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

    full page →fda device 510k ↗
    $SNN30.11+1.41%
    $CBLL19.55-2.25%
    $MDCE0.00020.00%
    $STE237.47+2.45%
    $RMD220.38+5.13%
    $FOFO3.0000+2.39%