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5,000 catalysts · 18,987 approval · 5,000 device 510k · 4,876 phase readout · 4,728 grant · 2,415 8k filing · 2,000 device pma

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type: device 510k×clear all
type
  • approval18,987
  • device 510k5,000
  • phase readout4,876
  • grant4,728
  • 8k filing2,415
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • earnings295
  • therapy area

    no tagged catalysts yet

    Week of Jan 13, 2025

    10
    ›Jan 17, 2025device 510k555d agoMED-EL Elektromedizinische Geräte GmbH — mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k555d agoWilson-Cook Medical, Inc. — Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k555d agoMedtronic Sofamor Danek, Inc. — Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft Granules (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k555d agoSmart Denture Conversions, LLC — Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k555d agoGe Medical Systems Israel, Functional Imaging — Aurora (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k555d agoNeoventa Medical AB — Goldtrace Fetal Spiral Electrode (FSE) (CNS000004) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k555d agoMyocene — Myocene (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k555d agoUnity Medical, Inc. — VersaD Delivery Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k555d agoTrue Indicating, LLC — Type 5 Integrating Indicator for Steam (CSPN-15) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 19, 2025device 510k553d agoNavi Medical Technologies — Neonav ECG Tip Location System (510k cleared)Medical Care Technologies Inc.

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

    full page →fda device 510k ↗

    Week of Jan 20, 2025

    38
    ›Jan 21, 2025device 510k551d 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 510k

    Week of Jan 27, 2025

    2
    ›Jan 27, 2025device 510k545d 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 22 of 100
    next →
    551d ago
    Wontech Co., Ltd. — Oligio X (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 21, 2025device 510k551d 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 510k551d 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 510k551d 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 510k551d 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 510k550d 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 510k550d agoNatus Neurology Incorporated — Nicolet EDX (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 22, 2025device 510k550d agoArthrex, Inc. — Arthrex NanoScope System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 22, 2025device 510k550d agoDepuy Ireland UC — EMPHASYS Acetabular System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 22, 2025device 510k550d 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 510k550d agoBiodynamik, Inc. — XT3 System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 22, 2025device 510k550d agoIschemaview, Inc. — Rapid Neuro3D (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 22, 2025device 510k550d 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 510k550d 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 510k550d 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 510k550d 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 510k550d 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 510k549d 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 510k549d 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 510k549d 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 510k549d 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 510k549d 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 510k549d agoAcumed, LLC — Acu-Sinch Knotless Mini (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 23, 2025device 510k549d agoCyncronus, LLC — CephNinja (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 23, 2025device 510k549d 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 510k549d 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 510k549d 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 510k548d 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 510k548d 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 510k548d 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 510k548d 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 510k548d agoElliquence, LLC — AxCess® Expandable Interbody System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 24, 2025device 510k548d 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 510k548d 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 510k548d 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 510k548d 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 510k548d 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 ↗
    545d ago
    Firstar Dental Company — Firstar Dental Unit (510k cleared)

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

    full page →fda device 510k ↗
    $MDCE0.00020.00%
    $CLPT
    $ICUI157.44+2.59%