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1,383 catalysts · 3,603 8k filing · 2,377 grant · 2,049 approval · 1,383 device 510k · 1,000 device adverse event · 930 device pma

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2026-08-24: 0 catalysts2026-08-25: 0 catalysts2026-08-26: 0 catalysts2026-08-27: 0 catalysts2026-08-28: 30 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: 1 catalyst2026-10-01: 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 catalysts2026-11-16: 0 catalysts2026-11-17: 0 catalysts2026-11-18: 0 catalysts2026-11-19: 0 catalysts2026-11-20: 0 catalysts2026-11-21: 0 catalysts2026-11-22: 0 catalysts
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type: device 510k×from 2025-11-03×clear all
type
  • 8k filing3,603
  • grant2,377
  • approval2,049
  • device 510k1,383
  • device adverse event1,000
  • device pma930
device recall
912
  • earnings585
  • recall364
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Nov 3, 2025

    50
    ›Nov 3, 2025device 510k299d agoRoche Molecular Systems, Inc. — cobas CMV (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 3, 2025device 510k299d agoShanghai 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 510k299d agoRoche Molecular Systems, Inc. — cobas HCV (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 3, 2025device 510k299d 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 510k299d 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 510k299d agoPie Medical Imaging BV — 3mensio Workstation (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 3, 2025device 510k299d 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 510k299d agoMidmark Corporation — Midmark Dental Delivery System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 3, 2025device 510k299d 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 510k299d agoNightguard Express, LLC — NightGuard Aire Max (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 4, 2025device 510k298d 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 510k298d 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 510k298d 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 510k298d agoVieworks Co., Ltd. — VXvue (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 4, 2025device 510k298d agoMedcad — MedCAD® AccuStride™ System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 4, 2025device 510k298d 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 510k298d 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 510k298d 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 510k298d 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 510k297d 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 510k297d 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 510k297d agoPhasor Health, LLC — EVAC-MRI (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 5, 2025device 510k297d 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 510k297d 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 510k297d 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 510k296d 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 510k296d 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 510k296d agoAdaptix Limited — Adaptix Ortho350 (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 6, 2025device 510k296d 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 510k296d agoPace Surgical — Ultra™ Compression Screw System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 6, 2025device 510k296d agoAiomega, LLC — AIO Breathe (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 6, 2025device 510k296d agoAidoc Medical , Ltd. — BriefCase-Triage (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 6, 2025device 510k296d 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 ↗
    ›Nov 6, 2025device 510k296d agoMedical Bees GmbH — mb-FIX Cranial Stabilization Systems (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 6, 2025device 510k296d agoStereotaxis, Inc. — Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS) (510k cleared)Stereotaxis, Inc.

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

    full page →fda device 510k ↗
    ›Nov 6, 2025device 510k296d agoCatalyst Orthoscience, Inc. — Catalyst F1x Shoulder System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 6, 2025device 510k296d agoHebei Keylaser Sci-Tech Co.,Ltd — Q-Switched Nd:Yag laser (K690) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 6, 2025device 510k296d agoHubly, Inc. — Hubly Drill (H100) (510k cleared)Petros Pharmaceuticals, Inc.

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

    full page →fda device 510k ↗
    ›Nov 6, 2025device 510k296d agoDmp Dental Industry S.A. — MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 7, 2025device 510k295d agoS.I.N. Implant System Ltda — S.I.N. Tapered Pro Conical Zygoma Implant System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 7, 2025device 510k295d agoBrainsway , Ltd. — BrainsWay Deep TMS System (510k cleared)Brainsway Ltd.

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

    full page →fda device 510k ↗
    ›Nov 7, 2025device 510k295d agoInion OY — Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 7, 2025device 510k295d agoImvaria, Inc. — Fibresolve (with PCCP) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 7, 2025device 510k295d agoDreve Dentamid GmbH — Primeprint Direct Aligner (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 7, 2025device 510k295d agoHebei Keylaser Sci-Tech Co.,Ltd — CO2 Laser Therapy System (K106) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 7, 2025device 510k295d agoShenzhen Mindray Bio-Medical Electronics Co., Ltd. — Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S, Consona EI, Consona EF, Consona N5 Elite, Consona N5 Ultra, Consona N3, Consona N3 Exp Diagnostic Ultrasound System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 7, 2025device 510k295d agoBaoding Te'Anzhou Electronic Technology Co., Ltd. — Medical Diode Laser Systems (VeinCure) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 7, 2025device 510k295d agoRollz International BV — Electric Wheelchair (Rollz Motion Electric 2M) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 7, 2025device 510k295d agoUlrich GmbH & Co. KG — ulrichINJECT CT Motion (XD 8000) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 7, 2025device 510k295d agoPremier Dental Products Company — MultiMatch Flow Chameleon AntiMicrobial Composite (510k cleared)

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

    full page →fda device 510k ↗
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    $BWAY
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