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2,780 catalysts · 4,728 grant · 3,603 8k filing · 2,780 device 510k · 2,724 approval · 2,000 device recall · 1,959 device pma

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type: device 510k×from 2025-06-03×clear all
type
  • grant4,728
  • 8k filing3,603
  • device 510k2,780
  • approval2,724
  • device recall2,000
  • device pma1,959
device adverse event
1,000
  • recall693
  • earnings585
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Jun 2, 2025

    50
    ›Jun 3, 2025device 510k454d agoRz Medizintechnik GmbH — RZ Resectoscope System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 3, 2025device 510k454d agoGlove One, LLC — GLOVEONE™ Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for use with Chemotherapy Drugs and Fentanyl] (510k cleared)NutriBand Inc.

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

    full page →fda device 510k ↗
    ›Jun 3, 2025device 510k454d agoKardium, Inc. — Globe Introducer (601-01001) (510k cleared)Kardigan Inc

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

    full page →fda device 510k ↗
    ›Jun 3, 2025device 510k454d agoCintron Medical Corporation — gi2000 Electrosurgical Generator (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 3, 2025device 510k454d agoPhasor Health, LLC — EVAC (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 3, 2025device 510k454d agoSpinal Simplicity, LLC — Patriot SI Implant System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 3, 2025device 510k454d agoPentax of America, Inc. — PENTAX Medical Video Processor (EPK-i8020c) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 3, 2025device 510k454d agoBalt USA, LLC — Raptor Aspiration Catheter; Balt Aspiration Tubing Set (510k cleared)Bayer USA LLC

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

    full page →fda device 510k ↗
    ›Jun 3, 2025device 510k454d agoClemde SA DE CV — Partial Flex (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 3, 2025device 510k454d agoBecton Dickinson Infusion Therapy Systems, Inc. — BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 3, 2025device 510k454d agoAroa Biosurgery , Ltd. — Endoform Reconstructive Template - PLGA (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 3, 2025device 510k454d agoSerim Research — DISINTEK™ PA Test Strips (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 4, 2025device 510k453d agoPhilips Medical Systems Nederland B.V. — Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System (510k cleared)

    Product code: LNH. Advisory committee: Radiology. Type: Special

    full page →fda device 510k ↗
    ›Jun 4, 2025device 510k453d agoId Korea Co., Ltd. — ID LIGHT CURE SYSTEM (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 4, 2025device 510k453d agoOlympus Medical Systems Corporation — Disposable Balloon Catheter B5-2C (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 4, 2025device 510k453d agoPhyscade, Inc. — PhysCade System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 4, 2025device 510k453d agoMedifield Medical Co., Ltd. — Montblanc Plate System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 4, 2025device 510k453d agoNg Biotech — NG-Test® CTX-M MULTI (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 4, 2025device 510k453d agoJkh Health Co., Ltd. — Ultrasound Stimulator (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 4, 2025device 510k453d agoWeero Co., Ltd. — EVE Synergy (EVE-20M) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 4, 2025device 510k453d agoSurgify Medical OY — Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1); Surgify Halo (40.070.NVG.H1); Surgify Halo (40.125.NVG.H1); Surgify Halo (40.000.SEE.H1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 4, 2025device 510k453d agoBarbaras Development, Inc. — 0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 4, 2025device 510k453d agoSk Zen, LLC — LubriZenzs (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 4, 2025device 510k453d agoBrainlab , Ltd. — TraumaCad Neo (1.1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 4, 2025device 510k453d agoProprio, Inc. — Paradigm System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 4, 2025device 510k453d agoThe ScottCare Corporation — TeleRehab Aermos Cardiopulmonary Rehabilitation (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 4, 2025device 510k453d agoPromisemed Hangzhou Meditech Co., Ltd. — Blood collection tube holders (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 4, 2025device 510k453d agoKerecis Limited — Tendon Protect (50242) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 5, 2025device 510k452d agoJiangsu Yuyue Medical Equipment & Supply Co., Ltd. — Portable Oxygen Concentrator (Spirit-3) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 5, 2025device 510k452d agoPhilips DS North America, LLC — UroNav 4 (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 5, 2025device 510k452d agoGrumpy Innovation, Inc. — Portare System (FA-001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 5, 2025device 510k452d agoEstetic Ceram AG — zirkon; structure; LFU shades, stains and glazes (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 5, 2025device 510k452d agoCorin U.S.A. Limited — Trinity EVO Acetabular Shell (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 5, 2025device 510k452d agoNihon Kohden Digital Health Solutions, LLC — Central Station (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 5, 2025device 510k452d agoIcu Medical, Inc. — Clave™ Neutral-Displacement Needlefree Connectors (510k cleared)ICU MEDICAL INC/DE

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

    full page →fda device 510k ↗
    ›Jun 5, 2025device 510k452d agoOlympus Medical Systems Corp. — Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 5, 2025device 510k452d agoShenzhen Idea Light Limited — Red Light Hair Growth Cap (LP-RJVGRW-BLK) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 5, 2025device 510k452d agoSurgical Instrument Service and Savings, Inc. — Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 5, 2025device 510k452d agoDeepHealth, Inc. — TechLive (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 5, 2025device 510k452d agoGe Medical Systems, LLC — Sonic DL (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 5, 2025device 510k452d agoSynapse Biomedical, Inc. — Synchrony (20-3000) (510k cleared)RNR BioMedical Inc

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

    full page →fda device 510k ↗
    ›Jun 5, 2025device 510k452d agoMedtronic Navigation, Inc. — Stealth™ Spine Clamps; ModuLeX™ Shank Mounts (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 5, 2025device 510k452d agoBrightheart — BrightHeart View Classifier (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k451d agoGlobus Medical, Inc. — ONVOY™ Acetabular System (510k cleared)GLOBUS MEDICAL INC

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k451d agoHebei JT Medical Co., Ltd. — Nd: YAG Laser Therapy System (QN-1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k451d agoGeister Medizin Technik GmbH — Geister K-Rex rongeurs (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k451d agoSpine Wave, Inc. — Annex® 2 Adjacent Level System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k451d agoCreo Medical, Ltd. — SpydrBlade Flex Instrument (PRD-RG1-001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k451d agoSora Neuroscience, Inc. — Cirrus Resting State fMRI Software (510k cleared)Alto Neuroscience, Inc.

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k451d agoQuanta System Spa — Discovery Pico; Discovery Pico Plus; Discovery Pico Derm (510k cleared)

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

    full page →fda device 510k ↗
    ← prev
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    $NTRB2.9000-11.59%
    $GMED79.93+1.27%
    $ANRO35.13-3.22%
    $ICUI175.100.00%