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1,945 catalysts · 4,728 grant · 3,603 8k filing · 2,593 approval · 1,945 device 510k · 1,575 device recall · 1,351 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: 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: 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 2025-09-03×clear all
type
  • grant4,728
  • 8k filing3,603
  • approval2,593
  • device 510k1,945
  • device recall1,575
  • device pma1,351
device adverse event
1,000
  • earnings585
  • recall544
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Sep 1, 2025

    42
    ›Sep 3, 2025device 510k361d agoAlphatec Spine — IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 3, 2025device 510k361d agoRestor3D — Kinos Total Ankle System (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 3, 2025device 510k361d agoMedicreations, LLC — MEDILIGHT (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 3, 2025device 510k361d agoForest Devices, Inc. — SignalNED System (Model RE) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 3, 2025device 510k361d agoA-1 Engineering — NeurotriS (SX2500); NeurotriS (SX3800) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 3, 2025device 510k361d agoAvita Corporation — AViTA Arm Type Blood Pressure Monitor Cuff (510k cleared)Teva Pharmaceuticals USA Inc

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

    full page →fda device 510k ↗
    ›Sep 3, 2025device 510k361d agoDongguan E-Test Technology Co., Ltd. — Automatic Upper Arm Blood Pressure Monitor (BA-831X, BA-832X, BA-833X, BA-837X, BA-838X, BA-842X, BA-843X, BA-845X, BA-847X, BA-849X, BA-851X, BA-852X, BA-855X, BA-835, BA-836, BA-839, BA-840, BA-856) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 3, 2025device 510k361d agoBlessing Cathay Corporation — AquaCast Mask (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 3, 2025device 510k361d agoBeijing Superlaser Technology Co., Ltd. — Diode laser therapy device (VADER) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 3, 2025device 510k361d agoAgnes Medical Co., Ltd. — AGNES Ultra (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 3, 2025device 510k361d agoArterys, Inc. — Tempus Pixel (510k cleared)Arteris, Inc.

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

    full page →fda device 510k ↗
    ›Sep 3, 2025device 510k361d agoPrismatik Dentalcraft, Inc. — BruxZir® NOW (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 4, 2025device 510k360d agoCarestream Health, Inc. — Image Suite (510k cleared)HEALTHSTREAM INC

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

    full page →fda device 510k ↗
    ›Sep 4, 2025device 510k360d agoIschemaview, Inc. — Rapid Obstructive Hydrocephalus, Rapid OH (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 4, 2025device 510k360d agoOptina Diagnostics, Inc. — Optina-4C (MHRC-C1N) (510k cleared)Co-Diagnostics, Inc.

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

    full page →fda device 510k ↗
    ›Sep 4, 2025device 510k360d agoCareverse Technology Pte. , Ltd. — Careverse CoronaryDoc (Careverse CoronaryDoc) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 4, 2025device 510k360d agoBayer Medical Care, Inc. — Ball Joint Guide Array (66295) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 4, 2025device 510k360d agoMicrobot Medical , Ltd. — LIBERTY Endovascular Robotic System (LIBERTYOS) (510k cleared)Microbot Medical Inc.

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

    full page →fda device 510k ↗
    ›Sep 4, 2025device 510k360d agoMicowey Medical Equipment (Guangxi) Co., Ltd. — Intense Pulsed Light Therapy Device (MMABM-1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 4, 2025device 510k360d agoThe Surgical Company International BV (As Tsc Life) — Fluido® AirGuard System (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 4, 2025device 510k360d agoMag & More GmbH — Apollo TMS Therapy System (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 4, 2025device 510k360d agoGuilin Woodpecker Medical Instrument Co., Ltd. — Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 4, 2025device 510k360d agoMedacta International S.A. — NextAR(TM) Shoulder Platform (510k cleared)Stemedica International S.A.

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

    full page →fda device 510k ↗
    ›Sep 4, 2025device 510k360d agoMedtronic Sofamor Danek USA, Inc. — Endoskeleton™ Interbody Systems (510k cleared)Medtronic USA Inc

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

    full page →fda device 510k ↗
    ›Sep 4, 2025device 510k360d agoMvision AI OY — Dose+ (1.0) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 4, 2025device 510k360d agoOniris — Oniris; Oniris Plus (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 4, 2025device 510k360d agoABBOTT MEDICAL — EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite™ X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 4, 2025device 510k360d agoClinical Laserthermia Systems, AB — Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 4, 2025device 510k360d agoMedical Microinstruments, Inc. — Symani Surgical System (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 4, 2025device 510k360d agoShenzhen Kaiyan Medical Equipment Co., Ltd. — KALA MINI 2.0 (KALA-04) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 5, 2025device 510k359d agoItamar Medical , Ltd. — WatchPAT400 (WP400) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 5, 2025device 510k359d agoZhejiang YiGao Medical Technology Co., Ltd. — Ureteral Access Sheath (510k cleared)Zhejiang Xinkanghe Biomedical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Sep 5, 2025device 510k359d ago3D-Shaper Medical S.L — 3D-SHAPER (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 5, 2025device 510k359d agoGenabio Diagnostics, Inc. — GenaCheck COVID-19 Rapid Self-Test (510k cleared)Co-Diagnostics, Inc.

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

    full page →fda device 510k ↗
    ›Sep 5, 2025device 510k359d agoShandong Int Medical Instruments Co., Ltd. — High Pressure Tubing (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 5, 2025device 510k359d agoPrytime Medical Devices, Inc. — pREBOA-PRO Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 5, 2025device 510k359d agoIntravent Medical Partners — SOLOPASS 2.0 System (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 5, 2025device 510k359d agoBard Access Systems, Inc. — Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable Implantable Port; PowerPort™ duo M.R.I. ™ Implantable Port (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 5, 2025device 510k359d agoShenzhen Mindray Bio-Medical Electronics Co., Ltd. — ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound System (VMM-ICE-02) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 5, 2025device 510k359d agoIntuitive Surgical, Inc. — Ion Endoluminal System (IF1000) (510k cleared)INTUITIVE SURGICAL INC

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

    full page →fda device 510k ↗
    ›Sep 5, 2025device 510k359d agoThermo Fisher Scientific — The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL (510k cleared)THERMO FISHER SCIENTIFIC INC.

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

    full page →fda device 510k ↗
    ›Sep 5, 2025device 510k359d agoSuturetech, Inc. — All-Suture Dual Anchor System (510k cleared)

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

    full page →fda device 510k ↗

    Week of Sep 8, 2025

    8
    ›Sep 8, 2025device 510k356d agoRev Neuro, LLC — DUO Microcatheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 8, 2025device 510k
    ← prev
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    356d ago
    Neurologica Corporation — OmniTom Elite with PCD (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 8, 2025device 510k356d agoQure.Ai Technologies — qER-CTA (v1.0) (510k cleared)BMP AI Technologies, Inc.

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

    full page →fda device 510k ↗
    ›Sep 8, 2025device 510k356d agoIntuitive Surgical, Inc. — da Vinci Surgical System (IS5000) (510k cleared)INTUITIVE SURGICAL INC

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

    full page →fda device 510k ↗
    ›Sep 8, 2025device 510k356d agoMicro-Tech (Nanjing) Co., Ltd. — Dual Action Tissue Closure Device (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 8, 2025device 510k356d agoShenzhen TPH Technology Co., Ltd. — Wearable Breast Pump (Model S33) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Sep 8, 2025device 510k356d agoTechsomed Medical Technologies — BioTraceIO Vision (V1.7) (510k cleared)Medical Care Technologies Inc.

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

    full page →fda device 510k ↗
    ›Sep 8, 2025device 510k356d agoMaxxos Medical GmbH — MAXXOS P.A.C.E. Foot & Ankle Plating System (510k cleared)Laxxon Medical GmbH

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

    full page →fda device 510k ↗
    $CODX1.51000.00%
    $ISRG372.60+1.51%
    $MBOT
    $AIP
    $TMO447.81+1.31%
    $HSTM
    $CODX1.51000.00%
    $BMPA
    $ISRG372.60+1.51%
    $FRTRY
    $MDCE0.00020.00%