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calendar

3,940 catalysts · 4,728 grant · 3,940 device 510k · 3,100 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 2025-01-21×clear all
type
  • grant4,728
  • device 510k3,940
  • approval3,100
  • 8k filing3,045
  • device pma2,000
  • device recall2,000
device adverse event
1,000
  • recall947
  • earnings579
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Jan 20, 2025

    38
    ›Jan 21, 2025device 510k567d agoMedical Brands Laboratories B.V. — Advanced Cryo Wart Remover (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 21, 2025device 510k567d agoWontech Co., Ltd. — Oligio X (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 21, 2025device 510k567d agoHathor Professional Skincare , Ltd. — Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil Luxe Vanilla Personal Lubricant (models 1119, 1120); Sutil Luxe Coconut Personal Lubricant (models 1121, 1122); Sutil Luxe Mint Personal Lubricant (models 1117, 1118) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 21, 2025device 510k567d agoShenzhen HugeMed Medical Technical Development Co., Ltd. — Biliary Pancreaticobiliary Scope System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 21, 2025device 510k567d agoPrecision AI Pty, Ltd. — Precision AI Surgical Planning System (PAI-SPS) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 21, 2025device 510k567d agoZiehm Imaging GmbH — Ziehm Vision RFD 3D (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 22, 2025device 510k566d agoHunan Endoso Life Technology Co., Ltd. — Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12-S2) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 22, 2025device 510k566d agoNatus Neurology Incorporated — Nicolet EDX (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 22, 2025device 510k566d agoArthrex, Inc. — Arthrex NanoScope System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 22, 2025device 510k566d agoDepuy Ireland UC — EMPHASYS Acetabular System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 22, 2025device 510k566d agoCompex, Spol, S.R.O. — JETT Medical II (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 22, 2025device 510k566d agoBiodynamik, Inc. — XT3 System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 22, 2025device 510k566d agoIschemaview, Inc. — Rapid Neuro3D (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 22, 2025device 510k566d agoIndiba S. A. U. — Reverso Pro System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 22, 2025device 510k566d agoIcu Medical, Inc. — Rio™ Drug Reconstitution Transfer Device (510k cleared)ICU MEDICAL INC/DE

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

    full page →fda device 510k ↗
    ›Jan 22, 2025device 510k566d agoPersyst Development Corporation — Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 22, 2025device 510k566d agoSuturion AB — Suture-TOOL System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 22, 2025device 510k566d agoEpic Medical Pte. , Ltd. — ZeroClear™ Bag Access (423100) (510k cleared)

    Product code: ONB. Advisory committee: General Hospital. Type: Special

    full page →fda device 510k ↗
    ›Jan 23, 2025device 510k565d agoShenzhen Launch Electrical Co., Ltd. — Rotatable Connector (5944RL) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 23, 2025device 510k565d agoZhejiang Seedream Medical Equipment Co., Ltd. — Mobility Scooter (S-01); Mobility Scooter (S-02) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 23, 2025device 510k565d agoOts Medical , Ltd. — OTS 25-L (100-5) (510k cleared)KAHR medical Ltd

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

    full page →fda device 510k ↗
    ›Jan 23, 2025device 510k565d agoShanghai Samedical & Plastic Instruments Co., Ltd. — RF Cannula (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 23, 2025device 510k565d agoLife Spine, Inc. — ProLift Pivot Expandable Spacer System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 23, 2025device 510k565d agoAcumed, LLC — Acu-Sinch Knotless Mini (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 23, 2025device 510k565d agoCyncronus, LLC — CephNinja (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 23, 2025device 510k565d agoTerarecon,Inc. — TeraRecon Aorta.CT (1.1.0) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 23, 2025device 510k565d agoMurata Vios, Inc. — Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 2050 (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 23, 2025device 510k565d agoAuris Health, Inc. — MONARCH™ Platform (MON-000008) (510k cleared)

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

    full page →fda device 510k ↗
    ›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

    12
    ›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 ↗
    $CLPT
    $ICUI182.42-1.16%
    $MMM
    $ARW226.78+1.76%
    $CNMD32.58+1.46%
    $FRTRY