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5,000 catalysts · 18,987 approval · 5,347 phase readout · 5,000 device 510k · 4,728 grant · 2,603 8k filing · 2,000 device pma

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2026-08-03: 4 catalysts2026-08-04: 13 catalysts2026-08-05: 17 catalysts2026-08-06: 11 catalysts2026-08-07: 1 catalyst2026-08-08: 0 catalysts2026-08-09: 0 catalysts2026-08-10: 2 catalysts2026-08-11: 1 catalyst2026-08-12: 1 catalyst2026-08-13: 1 catalyst2026-08-14: 1 catalyst2026-08-15: 0 catalysts2026-08-16: 0 catalysts2026-08-17: 0 catalysts2026-08-18: 1 catalyst2026-08-19: 0 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: 0 catalysts2026-08-27: 0 catalysts2026-08-28: 0 catalysts2026-08-29: 0 catalysts2026-08-30: 0 catalysts2026-08-31: 0 catalysts2026-09-01: 1 catalyst2026-09-02: 0 catalysts2026-09-03: 0 catalysts2026-09-04: 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: 0 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: 0 catalysts2026-10-09: 0 catalysts2026-10-10: 0 catalysts2026-10-11: 0 catalysts2026-10-12: 0 catalysts2026-10-13: 0 catalysts2026-10-14: 0 catalysts2026-10-15: 0 catalysts2026-10-16: 0 catalysts2026-10-17: 0 catalysts2026-10-18: 0 catalysts2026-10-19: 0 catalysts2026-10-20: 1 catalyst2026-10-21: 1 catalyst2026-10-22: 2 catalysts2026-10-23: 0 catalysts2026-10-24: 0 catalysts2026-10-25: 0 catalysts2026-10-26: 0 catalysts2026-10-27: 2 catalysts2026-10-28: 1 catalyst2026-10-29: 3 catalysts2026-10-30: 0 catalysts2026-10-31: 0 catalysts2026-11-01: 0 catalysts
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type: device 510k×clear all
type
  • approval18,987
  • phase readout5,347
  • device 510k5,000
  • grant4,728
  • 8k filing2,603
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • pdufa347
  • therapy area

    no tagged catalysts yet

    Week of Oct 27, 2025

    17
    ›Oct 31, 2025device 510k276d 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 510k276d 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 510k276d 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 510k276d agoPhasor Health, LLC — GREEN (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 31, 2025device 510k276d 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 510k276d 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 510k276d 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 510k276d 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 510k276d 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 510k276d 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 510k276d 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 510k276d 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 510k276d 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 510k276d 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 510k276d 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 510k276d agoPulsenmore, Ltd. — Pulsenmore ES (510k cleared)Pulsenmore Ltd.

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

    full page →fda device 510k ↗
    ›Oct 31, 2025device 510k276d 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

    33
    ›Nov 3, 2025device 510k273d 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 73 of 100
    next →
    273d 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 510k273d agoRoche Molecular Systems, Inc. — cobas HCV (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 3, 2025device 510k273d 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 510k273d 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 510k273d agoPie Medical Imaging BV — 3mensio Workstation (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 3, 2025device 510k273d 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 510k273d agoMidmark Corporation — Midmark Dental Delivery System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 3, 2025device 510k273d 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 510k273d agoNightguard Express, LLC — NightGuard Aire Max (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 4, 2025device 510k272d 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 510k272d 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 510k272d 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 510k272d agoVieworks Co., Ltd. — VXvue (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 4, 2025device 510k272d agoMedcad — MedCAD® AccuStride™ System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 4, 2025device 510k272d 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 510k272d 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 ↗
    ›Nov 4, 2025device 510k272d agoMenovex Medical Technology (Shenzhen) Co., Ltd. — Tamburo Thulium Fiber Laser System (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Nov 4, 2025device 510k272d agoSiemens Medical Solutions USA, Inc. — Cios Select (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 5, 2025device 510k271d agoGlobus Medical, Inc. — ExcelsiusGPS™ Instruments (510k cleared)GLOBUS MEDICAL INC

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

    full page →fda device 510k ↗
    ›Nov 5, 2025device 510k271d agoPoly Medicure Limited — Polyshield Safety IV Catheters (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 5, 2025device 510k271d agoPhasor Health, LLC — EVAC-MRI (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 5, 2025device 510k271d agoWaldemar Link GmbH & Co. KG — Allure Hip Stem and Intramedullary Plugs (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 5, 2025device 510k271d agoViatherm Therapeutics, LLC — ViVY (510k cleared)VLP Therapeutics LLC

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

    full page →fda device 510k ↗
    ›Nov 5, 2025device 510k271d agoBeijing Sinovation Medical Technology Co., Ltd. — Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode (RSDE-12); Depth Electrode (RSDE-14); Depth Electrode (RSDE-16); Depth Electrode (RSDE-16F); Depth Electrode (RSDE-08S); Depth Electrode (RSDE-10S); Depth Electrode (RSDE-12S); Depth Electrode (RSDE-14S); Depth Electrode (RSDE-16S); Depth Electrode (RSDE-16G); Depth Electrode (RSDE-18); Depth Electrode (RSDE-18F); Depth Electrode (RSDE-18T); Depth Electrode (RSDE-20); Depth Electrode (RSDE-20F); Dept (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 6, 2025device 510k270d agoVenus Concept, Inc. — Venus Nova (FP-2001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 6, 2025device 510k270d agoMotive Health, Inc. — Motive™ Muscle Stimulator for Lower Back (OT01-1003) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 6, 2025device 510k270d agoAdaptix Limited — Adaptix Ortho350 (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 6, 2025device 510k270d agoHefei Chimed Intelligent Machine Co., Ltd. — Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 6, 2025device 510k270d agoPace Surgical — Ultra™ Compression Screw System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 6, 2025device 510k270d agoAiomega, LLC — AIO Breathe (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 6, 2025device 510k270d agoAidoc Medical , Ltd. — BriefCase-Triage (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 6, 2025device 510k270d agoTandem Diabetes Care, Inc. — Tandem Mobi insulin pump with interoperable technology (510k cleared)TANDEM DIABETES CARE INC

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

    full page →fda device 510k ↗
    $BDX165.62+0.10%
    $SSD
    $CBLL19.55-2.25%
    $PLSM
    $GMED79.93+1.27%
    $UTMD69.19+0.06%
    $MMSI85.01+1.99%
    $TNDM19.50+2.58%