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1,903 catalysts · 4,639 grant · 3,603 8k filing · 2,587 approval · 1,903 device 510k · 1,500 device recall · 1,315 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 2025-09-08×clear all
type
  • grant4,639
  • 8k filing3,603
  • approval2,587
  • device 510k1,903
  • device recall1,500
  • device pma1,315
device adverse event
1,000
  • earnings585
  • recall534
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Sep 8, 2025

    50
    ›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 510k356d agoNeurologica 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 ↗
    ›Sep 8, 2025device 510k356d agoTissium SA — Coaptium Connect with Tissium Light (510k cleared)

    Product code: SFD. Advisory committee: Neurology. Type: Special

    full page →fda device 510k ↗
    ›Sep 8, 2025device 510k356d agoShenzhen Root Innovation Technology Co., Ltd. — Momcozy Wearable Breast Pump (BP223) (510k cleared)Hang Feng Technology Innovation Co., Ltd.

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

    full page →fda device 510k ↗
    ›Sep 9, 2025device 510k355d agoStryker Instruments — PhotonBlade 3; PhotonBlade 3 Smoke Evacuation (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 9, 2025device 510k355d agoBeckman Coulter, Inc. — Access anti-HAV (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 9, 2025device 510k355d agoFresenius Medical Care North America — AquaA (510k cleared)Fresenius Medical Care AG

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

    full page →fda device 510k ↗
    ›Sep 9, 2025device 510k355d agoFresenius Medical Care Renal Therapies Group, LLC — Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby Dialysate RFP-403 (RFP-403-G); Bicarby Dialysate RFP-453 (RFP-453-W); Bicarby Dialysate RFP-453 (RFP-453-G); Bicarby Dialysate RFP-454 (RFP-454-W); Bicarby Dialysate RFP-454 (RFP-454-G); Bicarby Dialysate RFP-456 (RFP-456-W) (510k cleared)Fresenius Medical Care AG

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

    full page →fda device 510k ↗
    ›Sep 9, 2025device 510k355d agoSpringbok, Inc. (Dba Springbok Analytics) — MuscleView 2.0 (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 9, 2025device 510k355d agoEventum Orthopaedics, Ltd. — Quadsense (Quadsense and Quadsense Pro) (510k cleared)

    Product code: ONN. Advisory committee: Neurology. Type: Special

    full page →fda device 510k ↗
    ›Sep 9, 2025device 510k355d agoSiemens Healthcare GmbH — AI-Rad Companion Prostate MR (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 9, 2025device 510k355d agoHermes Medical Solutions AB — Hybrid Viewer (00859873006240) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 9, 2025device 510k355d agoGuangzhou Decheng Biotechnology Co., Ltd. — MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test (510k cleared)Guangzhou Zhiyi Biotechnology Co Ltd

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

    full page →fda device 510k ↗
    ›Sep 9, 2025device 510k355d agoDGNCT, LLC — Segmentron Viewer (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 9, 2025device 510k355d agoCardioset Medical , Ltd. — Edema Guard Monitor (EGM) CardioSet-001 (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 9, 2025device 510k355d agoShenzhen Yongquan Medical Devices Co., Ltd. — Water-soluble Personal Lubricant (Satin Gel Vitamin E flavor lubricant; Satin Gel Caramel flavor lubricant; Satin Gel Peach flavor lubricant; Satin Gel Strawberry flavor lubricant.) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 9, 2025device 510k355d agoShandong Guyue Healthcare Appliance Co., Ltd. — Electric Wheelchair (GY-E001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 10, 2025device 510k354d agoMerit Medical System, Inc. — Surfacer Inside-Out Access Catheter System (510k cleared)MERIT MEDICAL SYSTEMS INC

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

    full page →fda device 510k ↗
    ›Sep 10, 2025device 510k354d agoMr Surgical Solutions, LLC — OptiVu™ Shoulder (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 10, 2025device 510k354d agoFisher & Paykel Healthcare, Ltd. — F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented Full (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 10, 2025device 510k354d agoBeckman Coulter, Inc. — iQ200 Series (510k cleared)

    Product code: LKM. Advisory committee: Hematology. Type: Special

    full page →fda device 510k ↗
    ›Sep 10, 2025device 510k354d agoIntuitive Surgical, Inc. — da Vinci SP Surgical System (SP1098) (510k cleared)INTUITIVE SURGICAL INC

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

    full page →fda device 510k ↗
    ›Sep 10, 2025device 510k354d agoVizionfocus, Inc. — VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 10, 2025device 510k354d agoAngiowave Imaging, Inc. — AngioWaveNet (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 10, 2025device 510k354d agoPollogen, Ltd. — OptiLUV Device (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 10, 2025device 510k354d agoTimpel S.A. — Enlight 2100 (TPL-E2103-0) (510k cleared)TIM S.A.

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

    full page →fda device 510k ↗
    ›Sep 11, 2025device 510k353d agoSmith & Nephew Medical, Ltd. — RENASYS WOUND+ Dressing Kit with AIRLOCK Technology (510k cleared)SMITH & NEPHEW PLC

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

    full page →fda device 510k ↗
    ›Sep 11, 2025device 510k353d agoApple, Inc. — Hypertension Notification Feature (HTNF) (510k cleared)Apple Inc.

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

    full page →fda device 510k ↗
    ›Sep 11, 2025device 510k353d agoActive Life Scientific, Inc. — OsteoProbe (OP-100) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 11, 2025device 510k353d agoUroviu Corporation — UV5000 Handle (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 11, 2025device 510k353d agoAl.Chi.Mi.A. S.R.L — XTRA4 (510k cleared)

    Product code: LYX. Advisory committee: Unknown. Type: Traditional

    full page →fda device 510k ↗
    ›Sep 11, 2025device 510k353d agoMazor Robotics , Ltd. — Mazor X System / Mazor X Stealth Edition (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 11, 2025device 510k353d agoBosch Healthcare Solutions GmbH — Vivatmo pro-S (510k cleared)

    Product code: MXA. Advisory committee: Clinical Toxicology. Type: Traditional

    full page →fda device 510k ↗
    ›Sep 11, 2025device 510k353d agoTns Co., Ltd. — Serafin® (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 11, 2025device 510k353d agoGe Medical Systems, LLC — SIGNA™ Sprint (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 11, 2025device 510k353d agoAugment Intelligent Medical System (China) Co., Ltd. — Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 11, 2025device 510k353d agoImmunalysis Corporation — SEFRIA™ Hydrocodone Oral Fluid (510k cleared)

    Product code: DJG. Advisory committee: Clinical Toxicology. Type: Traditional

    full page →fda device 510k ↗
    ›Sep 11, 2025device 510k353d agoAirway Technologies D/B/A Airway Management — Nylon flexTAP(R) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 11, 2025device 510k353d agoBaylis Medical Technologies, Inc. — PowerWire® 14 Radiofrequency Guidewire Kit (510k cleared)Medical Care Technologies Inc.

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

    full page →fda device 510k ↗
    ›Sep 12, 2025device 510k352d agoSparrow Acoustics, Inc. — Stethophone Pro (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 12, 2025device 510k352d agoDongguan Yanxi Technology Co., Ltd. — LED Light Therapy Mask (2311, 2344, 2457, 2458) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 12, 2025device 510k352d agoErchonia Corporation — Erchonia EVRL (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 12, 2025device 510k352d agoMedShape, Inc. — DynaNail TTC Fusion System (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 12, 2025device 510k352d agoShenzhen Mindray Bio-Medical Electronics Co., Ltd. — ViewMateTM Ultrasound System (510k cleared)

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

    full page →fda device 510k ↗
    ← prev
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    $MDCE0.00020.00%
    $FMS23.27-0.56%
    $FMS23.27-0.56%
    $TIMB
    $ISRG372.60+1.51%
    $FRTRY
    $FOFO3.0000+2.39%
    $BMPA
    $ISRG372.60+1.51%
    $MMSI90.49+1.06%
    $SNN29.13-0.58%
    $AAPL298.01+0.70%
    $MDCE0.00020.00%