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calendar

3,912 catalysts · 4,728 grant · 3,912 device 510k · 3,076 approval · 3,045 8k filing · 2,000 device pma · 2,000 device recall

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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 2025-01-24×clear all
type
  • grant4,728
  • device 510k3,912
  • approval3,076
  • 8k filing3,045
  • device pma2,000
  • device recall2,000
device adverse event
1,000
  • recall935
  • earnings579
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Jan 20, 2025

    10
    ›Jan 24, 2025device 510k564d agoBridge TO Life, Ltd. — OrganProtex HTK Solution (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 24, 2025device 510k564d agoIndiba S. A. U. — Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY ); Indiba Diathermia Radiofrequency Activ Device (Activ ACT0309/CT9) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 24, 2025device 510k564d agoRoche Diagnostics Operations — Tina-quant Lipoprotein(a) Gen.2 Molarity (510k cleared)Dawn Sea Therapeutics

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

    full page →fda device 510k ↗
    ›Jan 24, 2025device 510k564d agoZhejiang Curaway Medical Technology Co., Ltd. — Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle (510k cleared)Zhejiang Xinkanghe Biomedical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Jan 24, 2025device 510k564d agoElliquence, LLC — AxCess® Expandable Interbody System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 24, 2025device 510k564d agoZhejiang Curaway Medical Technology Co., Ltd. — Bone Marrow Biopsy Needle (510k cleared)Zhejiang Xinkanghe Biomedical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Jan 24, 2025device 510k564d agoClearPoint Neuro, Inc. — ClearPoint System (Software Version 3.0) (510k cleared)ClearPoint Neuro, Inc.

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

    full page →fda device 510k ↗
    ›Jan 24, 2025device 510k564d agoIbex Medical Analytics , Ltd. — Galen™ Second Read™ (510k cleared)

    Product code: QPN. Advisory committee: Pathology. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 24, 2025device 510k564d agoMagentiq Eye, Ltd. — MAGENTIQ-COLO (ME-APDS) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 24, 2025device 510k564d agoWuhan Guangdun Technology Co.,Ltd.. — Enhanced Handheld Pain Relief Laser Instrument (GD-P-E) (510k cleared)

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

    full page →fda device 510k ↗

    Week of Jan 27, 2025

    40
    ›Jan 27, 2025device 510k561d agoBeijing Sano Laser S&T Development Co.,Ltd — CO2 Laser Therapy Systems (SHE-LSP003-1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 27, 2025device 510k
    ← prev
    page 1 of 79
    next →
    561d ago
    Firstar Dental Company — Firstar Dental Unit (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 27, 2025device 510k561d agoMedical Microinstruments, Inc. — Symani Surgical System (820-03830) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 27, 2025device 510k561d agoRaysolution Healthcare Co., Ltd. — Imaging system of positron emission and X-ray computed tomography (DigitMI 930) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 27, 2025device 510k561d agoBunkerHill Health — Bunkerhill AVC (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 28, 2025device 510k560d agoShenzhen Rainbow Technology Co., Ltd. — LED Light Therapy Mask (Model(s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J, RB-008JB) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Jan 28, 2025device 510k560d agoBrainlab AG — Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 28, 2025device 510k560d agoHuxley Medical — SANSA HSAT (510k cleared)

    Product code: MNR. Advisory committee: Anesthesiology. Type: Special

    full page →fda device 510k ↗
    ›Jan 28, 2025device 510k560d agoConmed Corporation — Argo Knotless GENESYS Anchor (510k cleared)CONMED Corp

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

    full page →fda device 510k ↗
    ›Jan 28, 2025device 510k560d ago3M Company — 3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490M (510k cleared)3M CO

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

    full page →fda device 510k ↗
    ›Jan 28, 2025device 510k560d agoInstrumentation Laboratory (IL) Co. — HemosIL CL HIT-IgG(PF4-H) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 28, 2025device 510k560d agoLg Electronics.Inc — Medical Monitor (27HS714S) (510k cleared)ARROW ELECTRONICS, INC.

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

    full page →fda device 510k ↗
    ›Jan 29, 2025device 510k559d agoGyder Surgical Pty, Ltd. — GYDER® Hip System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 29, 2025device 510k559d agoGM Dos Reis Industria e Comercio Ltda. — Versalock Upper Limb Plating System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 29, 2025device 510k559d agoSurcam Medical Devices and Developments, Ltd. — Surcam Dental Implant System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 29, 2025device 510k559d agoHunan Vathin Medical Instrument Co., Ltd. — Digital Video Processor (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 29, 2025device 510k559d agoGI Windows, Inc. — Self-Forming Magnet (FLEX SFM) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 29, 2025device 510k559d agoXenco Medical, LLC — Xenco Medical CancelleX Cervical Interbody System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 29, 2025device 510k559d agoAccess Bio, Inc. — CareSuperb™ COVID-19 Antigen Home Test (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 29, 2025device 510k559d agoHygea Medical Technology Co., Ltd. — Co-Ablation System with Sterile Co-Ablation Probe (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Jan 30, 2025device 510k558d agoMobius Mobility — iBOT® PMD (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 30, 2025device 510k558d agoShenzhen Zhongkemingwang Telecommunications Software Corp. — Wrist Blood Pressure Monitor (OHMS11, OHMS12) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 30, 2025device 510k558d agoMedacta International S.A. — MyShoulder Planner (5.3SSWPL) (510k cleared)Stemedica International S.A.

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

    full page →fda device 510k ↗
    ›Jan 30, 2025device 510k558d agoResponsive Arthroscopy, Inc. — Osprey Suture Anchor (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 30, 2025device 510k558d agoBTL Industries, Inc. — BTL-754 (510k cleared)NL INDUSTRIES INC

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

    full page →fda device 510k ↗
    ›Jan 30, 2025device 510k558d agoLaboratorios Biogalenic S.A. DE C.V. — Laboratorios Biogalenic Sterile Water for Inhalation, USP (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 30, 2025device 510k558d agoAbanza Tecnomed S.L — WasherCap™ Mini Fixation System (Model 45) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 30, 2025device 510k558d agoTaiwan Aulisa Medical Devices Technologies, Inc. — Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 30, 2025device 510k558d agoSeplou (Zhuhai) Co., Ltd. — Ureteral Access Sheath (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 30, 2025device 510k558d agoLiofilchem s.r.l. — MTS Ceftobiprole 0.002-32 µg/mL (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 30, 2025device 510k558d agoAbbott Molecular — simpli-COLLECT STI Test (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 30, 2025device 510k558d agoBard Peripheral Vascular, Inc. — Rotarex Atherectomy System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 30, 2025device 510k558d agoGuangdong Transtek Medical Electronics Co., Ltd. — TeleRPM Gen2 Blood Glucose Monitoring System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 31, 2025device 510k557d agoAvanos Medical, Inc. — Game Ready system (550500-04); Game Ready Control Unit (550550-04); Game Ready Full Leg Boot Wrap - Medium (590923-04); Game Ready Full Leg Boot Wrap - Large (590922-04); Game Ready C-T Spine Wrap (590502-04); Game Ready Half Leg Boot (590906-04); Game Ready Back Wrap (590500-04); Game Ready Hand/Wrist Wrap (590811-04); Game Ready Flexed Elbow Wrap (590903-04); Game Ready Straight Elbow Wrap (590200-04); Game Ready Shoulder Wrap, Medium, Right (590422-04); Game Ready Shoulder Wrap, La (510k cleared)AVANOS MEDICAL, INC.

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

    full page →fda device 510k ↗
    ›Jan 31, 2025device 510k557d agoZheJiang Decans Medical Devices Co., Ltd. — Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System (Thread-Fix Ultra Anchor); Crius PEEK Suture Anchor System (Helicoil Anchor); Crius PEEK Suture Anchor System (Pile Anchor) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 31, 2025device 510k557d agoMarzzan Lucas Jorge — AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 31, 2025device 510k557d agoLuxottica Group S.P.A. — Nuance Audio Hearing Aid Software (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 31, 2025device 510k557d agoSuzhou Master Machinery Manufacturing Co.,Ltd — Mobility Scooter (MS160A) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 31, 2025device 510k557d agoNanjing Synthgene Medical Technology Co., Ltd. — Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 31, 2025device 510k557d agoMotilitycount Aps — SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL) (510k cleared)

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

    full page →fda device 510k ↗
    $CLPT
    $NL6.0500-1.14%
    $FRTRY
    $MMM
    $CNMD32.58+1.46%
    $AVNS
    $ARW226.78+1.76%