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calendar

2,880 catalysts · 4,728 grant · 3,603 8k filing · 2,880 device 510k · 2,744 approval · 2,000 device pma · 2,000 device recall

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2026-08-24: 0 catalysts2026-08-25: 0 catalysts2026-08-26: 0 catalysts2026-08-27: 0 catalysts2026-08-28: 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: 1 catalyst2026-10-01: 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 catalysts2026-11-09: 1 catalyst2026-11-10: 0 catalysts2026-11-11: 0 catalysts2026-11-12: 0 catalysts2026-11-13: 0 catalysts2026-11-14: 0 catalysts2026-11-15: 0 catalysts2026-11-16: 0 catalysts2026-11-17: 0 catalysts2026-11-18: 0 catalysts2026-11-19: 0 catalysts2026-11-20: 0 catalysts2026-11-21: 0 catalysts2026-11-22: 0 catalysts
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type: device 510k×from 2025-05-23×clear all
type
  • grant4,728
  • 8k filing3,603
  • device 510k2,880
  • approval2,744
  • device pma2,000
  • device recall2,000
device adverse event
1,000
  • recall719
  • earnings585
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of May 19, 2025

    21
    ›May 23, 2025device 510k465d agoPearl, Inc. — Second Opinion® 3D (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k465d agoPiraeus Medical — 93 NeuFlex Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k465d agoKuros Biosciences B.V — MagnetOs MIS (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k465d agoGeske Beauty Tech GmbH — SmartAppGuidedTM MicroCurrent Face-Lift Pen 6 in 1 (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k465d agoShenzhen Ulike Smart Electronics Co., Ltd. — Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 GR, MI01 PP, MI01 RM, MI01 WG, MI01 WH, MI01 BK;UI04S PP, UI04S BU, UI04S WH, UI04S PN) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k465d agoLVIS Corporation — NeuroMatch (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k465d agoThe Binding Site Group , Ltd. — Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit (510k cleared)Dawn Sea Therapeutics

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k465d agoEizo Corporation — RadiForce MX317W-PA (510k cleared)

    Product code: PZZ. Advisory committee: Pathology. Type: Abbreviated

    full page →fda device 510k ↗
    ›May 23, 2025device 510k465d agoEwoosoft Co., Ltd. — Clever One (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k465d agoDepuy Ireland UC — RECLAIM Monobloc Revision Femoral Stem (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k465d agoEl Global Trade, Ltd. — IPL400 (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k465d agoSpineup, Inc. — Frida™ Anterior Cervical Plate System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k465d agoWellell, Inc. — WiZARD 520 Full Face Mask (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k465d agoABBOTT MEDICAL — ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid Mapping Catheter, Sensor Enabled™; Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™; Agilis™ NxT Steerable Introducer; Agilis™ NxT Steerable Introducer Dual-Reach™ (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k465d agoVenocare, Inc. — Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k465d agoDsi Dental Solutions, Ltd. — Sil-Flow (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k465d agoRivanna Medical, Inc. — Accuro 3S (510k cleared)Vivani Medical, Inc.

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k465d agoBrain Navi Biotechnology Co., Ltd. — Stereotaxic Guiding Surgical Devices, NaoTrac S (510k cleared)Avistone Biotechnology Co Ltd

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k465d agoFujifilm Corporation — FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L (510k cleared)Fujifilm Holdings Corp

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k465d agoDeepecho — DEEPECHO (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k465d agoStryker Endoscopy — Knotilus+ Biocomposite Knotless Anchor (510k cleared)

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

    full page →fda device 510k ↗

    Week of May 26, 2025

    29
    ›May 27, 2025device 510k461d agoPuritan Medical Products, LLC — Puritan PurSafe Plus Collection and Transport System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 27, 2025device 510k
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    page 1 of 58
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    461d ago
    Distalmotion SA — Dexter L6 System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 27, 2025device 510k461d agoPreventamed Technologies, Inc. Dba Surfacide Manufacturing — Helios+ UV-C System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 27, 2025device 510k461d agoNingbo Baichen Medical Devices Co., Ltd. — Electric Wheelchair (BC-EA5516, BC-EC8002, BC-EC8003, BC-EALD3) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 27, 2025device 510k461d agoOSSIO , Ltd. — OSSIOfiber® Suture Anchor (510k cleared)

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

    full page →fda device 510k ↗
    ›May 27, 2025device 510k461d agoMedicalgorithmics S.A. — DeepRhythmAI (510k cleared)

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

    full page →fda device 510k ↗
    ›May 27, 2025device 510k461d agoJjgc Indústria E Comércia DE Materiais Dentários S.A. — Neodent Implant System - Custom Abutments (510k cleared)

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

    full page →fda device 510k ↗
    ›May 27, 2025device 510k461d agoTheodent, LLC — Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Varnish (3% / Cherry); Rennou™ Varnish (3% / Bubble Gum) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 27, 2025device 510k461d agoShofu Dental Corporation — BEAUTIFIL II (510k cleared)

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

    full page →fda device 510k ↗
    ›May 27, 2025device 510k461d agoOlympus Medical Systems Corp. — Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614M (510k cleared)

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

    full page →fda device 510k ↗
    ›May 27, 2025device 510k461d agoMipont Medical Equipment Co., Ltd. — Integral Dental Units (510k cleared)

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

    full page →fda device 510k ↗
    ›May 27, 2025device 510k461d agoABBOTT MEDICAL — Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 28, 2025device 510k460d agoResmed Corp — myAir (510k cleared)RESMED INC

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

    full page →fda device 510k ↗
    ›May 28, 2025device 510k460d agoLivermoretech, Inc. — Europa (Alternative: AiRTouch) portable X-ray system (510k cleared)

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

    full page →fda device 510k ↗
    ›May 28, 2025device 510k460d agoPacific Care Limited — Disposable Prophy Angle (510k cleared)

    Product code: EGS. Advisory committee: Dental. Type: Abbreviated

    full page →fda device 510k ↗
    ›May 28, 2025device 510k460d agoShenzhen Insighters Medical Technology Co., Ltd. — Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0; Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B22A 5.5 /2.6; Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B26A 6.0/3.0; Insighters™ Insight Workstation iS-PF1. (510k cleared)

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

    full page →fda device 510k ↗
    ›May 28, 2025device 510k460d agoImperative Care, Inc. — Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing (510k cleared)

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

    full page →fda device 510k ↗
    ›May 28, 2025device 510k460d agoTermosalud S.L. — Zionic Pro Max (Radiofrequency) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 28, 2025device 510k460d agoBoston Scientific Corporation — OptiMap™ System (510k cleared)BOSTON SCIENTIFIC CORP

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

    full page →fda device 510k ↗
    ›May 28, 2025device 510k460d agoTaiwan Medical Imaging Co., Ltd. — TAIMedImg DeepMets (510k cleared)

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

    full page →fda device 510k ↗
    ›May 28, 2025device 510k460d agoSurGenTec, LLC — OsteoFlo HydroFiber (510k cleared)

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

    full page →fda device 510k ↗
    ›May 28, 2025device 510k460d agoOpcom Medical, Inc. — Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Ureteroscope (U-Scope)(2.5/1.2) (OMI161-2F25-CH12-US); Images Systems (Camera-Controlled Unit) (OMI01M12) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 28, 2025device 510k460d agoIradimed Corporation — MRidium 3870 MRI Infusion Pump System (3870) (510k cleared)IRADIMED CORP

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

    full page →fda device 510k ↗
    ›May 28, 2025device 510k460d agoIschemaview, Inc. — Rapid MLS (510k cleared)

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

    full page →fda device 510k ↗
    ›May 28, 2025device 510k460d agoSmart Soft Healthcare AD — CoLumboX (510k cleared)

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k459d agoShenzhen Astec Technology Co., Ltd. — TENS AND EMS (TENS and Muscle Stimulator) ( Model AS8012C,AS8016,AS8019,AS9020E,AS9026) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k459d agoBaylis Medical Company, Inc. — VersaCross Connect™ Transseptal Dilator (510k cleared)

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k459d agoReflow Medical, Inc. — Spur Peripheral Retrievable Stent System (510k cleared)

    Product code: SEU. Advisory committee: Cardiovascular. Type: Direct

    full page →fda device 510k ↗
    ›May 29, 2025device 510k459d agoMedtronic Navigation — Visualase V2 MRI-guided Laser Ablation System (9736422) (510k cleared)

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

    full page →fda device 510k ↗
    $VANI1.6000+18.52%
    $RMD220.38+5.13%
    $FRTRY
    $BSX46.84+0.36%
    $IRMD