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1,436 catalysts · 3,350 8k filing · 2,401 grant · 2,076 approval · 1,436 device 510k · 1,072 device recall · 1,000 device adverse event

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type: device 510k×from 2025-10-29×clear all
type
  • 8k filing3,350
  • grant2,401
  • approval2,076
  • device 510k1,436
  • device recall1,072
  • device adverse event1,000
device pma
950
  • earnings584
  • recall376
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Oct 27, 2025

    50
    ›Oct 29, 2025device 510k291d agoGE Medical Systems Ultrasound and Primary Care Diagnostics — LOGIQ E10 (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 29, 2025device 510k291d agoHuxley Medical — SANSA HSAT (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 29, 2025device 510k291d agoWright Medical Technology, Inc. (Stryker Corporation) — Synchfix EVT (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 29, 2025device 510k291d agoGE Medical Systems Ultrasound and Primary Care Diagnostics — LOGIQ E10s (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 29, 2025device 510k291d agoInari Medical — Protrieve Sheath (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 29, 2025device 510k291d agoMedtronic, Ireland — Telescope Guide Extension Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 29, 2025device 510k291d agoSmith & Nephew, Inc. — AETOS Shoulder System Meta Humeral Prosthesis Size 0 (510k cleared)SMITH & NEPHEW PLC

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

    full page →fda device 510k ↗
    ›Oct 29, 2025device 510k291d agoOd-Os GmbH — Navilas Laser System 577sl (156691) (510k cleared)

    Product code: HQF. Advisory committee: Ophthalmic. Type: Traditional

    full page →fda device 510k ↗
    ›Oct 29, 2025device 510k291d agoFissiontech, LLC — Difiney Advanced Anti Snoring Device 4.0 (510k cleared)

    Product code: LRK. Advisory committee: Dental. Type: Special

    full page →fda device 510k ↗
    ›Oct 29, 2025device 510k291d agoABBOTT MEDICAL — Seguin Annuloplasty Ring (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 29, 2025device 510k291d agoShenzhen Beacon Display Technology Co., Ltd. — LCD Monitor (C1216W, C822W, C821W) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 29, 2025device 510k291d agoShenzhen Root Innovation Technology Co., Ltd. — Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-) (510k cleared)Hang Feng Technology Innovation Co., Ltd.

    Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Special

    full page →fda device 510k ↗
    ›Oct 29, 2025device 510k291d agoArthrex, Inc. — Arthrex SutureTak Suture Anchor (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 29, 2025device 510k291d agoMaxx Orthopedics, Inc. — Freedom Infinia™ Total Knee System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 29, 2025device 510k291d agoOrtho-Clinical Diagnostics, Inc. — VITROS Immunodiagnostic Products hs Troponin I Reagent Pack (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 29, 2025device 510k291d agoSu-Ko Technologies, LLC — SER Pen Carain MicroSystem (MP1209SP) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 29, 2025device 510k291d agoGuangdong Optomedic Technologies, Inc. — 3D Laparoscope (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 29, 2025device 510k291d agoFH Industrie — JARVIS Diaphyseal Stem Standard (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 29, 2025device 510k291d agoMeduloc, LLC — Meduloc Intramedullary Fracture Fixation (IFF) System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 29, 2025device 510k291d agoYa-Man, Ltd. — Medi Lift Essential Eye Mask (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 30, 2025device 510k290d agoTornier, Inc. — Tornier Humeral Reconstruction System Max (Tornier HRS Max) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 30, 2025device 510k290d agoShenzhen Kaiyan Medical Equipment Co., Ltd. — Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 30, 2025device 510k290d agoDetax GmbH — Freeprint® denture flex (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 30, 2025device 510k290d agoImperative Care, Inc. — Zoom System (Zoom 4S Catheter) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 30, 2025device 510k290d agoCarefusion (Bd) — BD Alaris Pump Infusion Set (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 30, 2025device 510k290d agoArctx Medical — Arctx Cool Catheter Set (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 30, 2025device 510k290d agoHangzhou AllTest Biotech Co., Ltd. — AllTest Urinary Tract Infection Test (510k cleared)Hangzhou DAC Biotech Co Ltd

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

    full page →fda device 510k ↗
    ›Oct 30, 2025device 510k290d agoDiasorin Molecular, LLC — Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 30, 2025device 510k290d agoTaewoong Medical Co., Ltd. — Niti-S Esophageal Stent; Esophageal TTS Stent (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 30, 2025device 510k290d agoMerchsource, LLC — AIR COMPRESSION BOOTS 1018195,1018196 (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 30, 2025device 510k290d agoBoston Scientific Corporation — OBSIDIO™ Conformable Embolic (M0013972101010) (510k cleared)BOSTON SCIENTIFIC CORP

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

    full page →fda device 510k ↗
    ›Oct 30, 2025device 510k290d agoParagon Implant Mfg., LLC — GEN5 and GEN5+ Dental Implant System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 30, 2025device 510k290d agoCytrellis Biosystems, Inc. — ellacor System with Micro-Coring Technology (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 30, 2025device 510k290d agoViTAA Medical Solutions, Inc. — AiORTA - Plan (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 30, 2025device 510k290d agoM.I.Tech Co., Ltd. — HANAROSTENT Esophagus Upper (CCC) (510k cleared)YSX Tech Co., Ltd

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

    full page →fda device 510k ↗
    ›Oct 30, 2025device 510k290d agoBoston Scientific Corporation — Moses™ 200 D/F/L Laser Fiber (M0068130100); Moses™ 365 D/F/L Laser Fiber (M0068130110); Moses™ 550 D/F/L Laser Fiber (M0068130120) (510k cleared)BOSTON SCIENTIFIC CORP

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

    full page →fda device 510k ↗
    ›Oct 31, 2025device 510k289d agoApplied Medical Resources Corp. — Kii Structural Balloon Access System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 31, 2025device 510k289d agoApplied Medical Resources Corporation — Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 31, 2025device 510k289d agoVigodent Indústria E Comercio Ltda — Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set - 454g (1lb) (052327); Chroma Print Premium Fast Set - 454g (1lb) (052457); Chroma Print Premium Regular Set - 454g (1lb) (051460); Perfil Pro - 454g (1lb) (056213); Perfil Pro+ - 454g (1lb) (056121); Perfil Pro Chroma - 454g (1lb) (056122); Hydro Print Premium Fast Set - Multi Pack (056205); Hydro Print Premium Regular Set - Multi Pack (056208); Hydro Print Premium Fast Set - 9,07Kg (20lb) (056204); (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 31, 2025device 510k289d agoPhasor Health, LLC — GREEN (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 31, 2025device 510k289d agoPropper Manufacturing Co., Inc. — Chex-All Sterilization Pouches and Tubes (510k cleared)Simpson Manufacturing Co., Inc.

    Product code: FRG. Advisory committee: General Hospital. Type: Abbreviated

    full page →fda device 510k ↗
    ›Oct 31, 2025device 510k289d agoActuated Medical, Inc. — GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100 (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 31, 2025device 510k289d agoPersyst Development, LLC — 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 ↗
    ›Oct 31, 2025device 510k289d agoCanon Medical Systems Corporation — Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 31, 2025device 510k289d agoTerrats Medical SL — DESS Dental Smart Solutions (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 31, 2025device 510k289d agoOrthofix US, LLC — Firebird SI Navigation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 31, 2025device 510k289d agoBecton, Dickinson and Company — BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric Bacterial Panel Diluent for BD COR System (510k cleared)BECTON DICKINSON & CO

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

    full page →fda device 510k ↗
    ›Oct 31, 2025device 510k289d agoCeribell, Inc. — Ceribell Instant EEG Headcap (Small: C251, Medium: C252) (510k cleared)Ceribell, Inc.

    Product code: GXY. Advisory committee: Neurology. Type: Abbreviated

    full page →fda device 510k ↗
    ›Oct 31, 2025device 510k289d agoSanhe Meditech Co., Ltd. — Diode Laser Hair Removal Machine (GLD01) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 31, 2025device 510k289d agoMedacta International S.A. — MSS - Humeral reverse liners extension (510k cleared)Stemedica International S.A.

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

    full page →fda device 510k ↗
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    $YSXT
    $FOFO3.0000+2.39%
    $BSX51.83+0.27%
    $CBLL19.55-2.25%
    $SSD
    $SNN29.81-1.00%
    $BDX183.40+0.79%
    $BSX51.83+0.27%