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1,416 catalysts · 3,377 8k filing · 2,401 grant · 2,059 approval · 1,416 device 510k · 1,000 device adverse event · 949 device recall

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2026-08-17: 28 catalysts2026-08-18: 2 catalysts2026-08-19: 3 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: 9 catalysts2026-11-03: 18 catalysts2026-11-04: 22 catalysts2026-11-05: 37 catalysts2026-11-06: 2 catalysts2026-11-07: 0 catalysts2026-11-08: 0 catalysts2026-11-09: 1 catalyst2026-11-10: 0 catalysts2026-11-11: 0 catalysts2026-11-12: 0 catalysts2026-11-13: 0 catalysts2026-11-14: 0 catalysts2026-11-15: 0 catalysts
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type: device 510k×from 2025-10-30×clear all
type
  • 8k filing3,377
  • grant2,401
  • approval2,059
  • device 510k1,416
  • device adverse event1,000
  • device recall949
device pma
941
  • earnings584
  • recall364
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Oct 27, 2025

    33
    ›Oct 30, 2025device 510k292d 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 510k292d 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 510k292d agoDetax GmbH — Freeprint® denture flex (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 30, 2025device 510k292d 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 510k292d 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 510k292d agoArctx Medical — Arctx Cool Catheter Set (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 30, 2025device 510k292d 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 510k292d 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 510k292d 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 510k292d 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 510k292d 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 510k292d 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 510k292d 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 510k292d agoViTAA Medical Solutions, Inc. — AiORTA - Plan (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 30, 2025device 510k292d 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 510k292d 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 510k291d 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 510k291d 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 510k291d 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 510k291d agoPhasor Health, LLC — GREEN (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 31, 2025device 510k291d 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 510k291d 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 510k291d 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 510k291d 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 510k291d 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 510k291d 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 510k291d 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 510k291d 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 510k291d 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 510k291d 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 ↗
    ›Oct 31, 2025device 510k291d agoMaxx Orthopedics, Inc. — Freedom Metaphyseal Cone Implants (Metaphyseal Cones) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 31, 2025device 510k291d agoPulsenmore, Ltd. — Pulsenmore ES (510k cleared)Pulsenmore Ltd.

    Product code: SGJ. Advisory committee: Radiology. Type: Direct

    full page →fda device 510k ↗
    ›Oct 31, 2025device 510k291d agoShenzhen Sanping Image Technology Co., Ltd. — Flexible Ureterorenoscope system (Electronic Endoscope Image Processor, model: SP-TXCLQ12.1, Flexible Ureterorenoscope, model: SP-SNGSYJ 2.0, SP-SNGSYJ 2.2, SP-SNGSYJ 2.5, SP-SNGSYJ 2.8) (510k cleared)

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

    full page →fda device 510k ↗

    Week of Nov 3, 2025

    17
    ›Nov 3, 2025device 510k288d agoRoche Molecular Systems, Inc. — cobas CMV (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 3, 2025device 510k
    ← prev
    page 1 of 29
    next →
    288d ago
    Shanghai Lange Medtech Co., Ltd. — Kyphoplasty Balloon Dilatation Catheters (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 3, 2025device 510k288d agoRoche Molecular Systems, Inc. — cobas HCV (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 3, 2025device 510k288d agoMighty Oak Medical — Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 3, 2025device 510k288d agoZap Surgical Systems, Inc. — ZAP-X Radiosurgery System (ZAP-X) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 3, 2025device 510k288d agoPie Medical Imaging BV — 3mensio Workstation (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 3, 2025device 510k288d agoFUJIFILM Sonosite, Inc. — Sonosite MT Ultrasound System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 3, 2025device 510k288d agoMidmark Corporation — Midmark Dental Delivery System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 3, 2025device 510k288d agoHebei Dansong Medical Technology Co., Ltd. — Electric wheelchair (NSDS-01) (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Nov 3, 2025device 510k288d agoNightguard Express, LLC — NightGuard Aire Max (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 4, 2025device 510k287d agoGM Dos Reis Industria e Comercio Ltda. — GMReis Suture Anchors (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 4, 2025device 510k287d agoPrimed Medical Products, Inc. — PRIMED Surgical and Procedure Masks (510k cleared)UTAH MEDICAL PRODUCTS INC

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

    full page →fda device 510k ↗
    ›Nov 4, 2025device 510k287d agoKarma Mobility Co, Ltd. — Flexx Junior (FLX-J00, FLX-J50) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 4, 2025device 510k287d agoVieworks Co., Ltd. — VXvue (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 4, 2025device 510k287d agoMedcad — MedCAD® AccuStride™ System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 4, 2025device 510k287d agoApplied Medical Resources Corp. — Voyant® Open Fusion Device (EB240/Open Fusion) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 4, 2025device 510k287d agoMerit Medical Systems, Inc. — Merit Syringe (510k cleared)MERIT MEDICAL SYSTEMS INC

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

    full page →fda device 510k ↗
    $YSXT
    $PLSM
    $SSD
    $BSX51.77-0.13%
    $CBLL19.55-2.25%
    $BDX182.71-0.38%
    $UTMD69.19+0.06%
    $BSX51.77-0.13%
    $MMSI90.03-0.80%