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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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2026-07-27: 0 catalysts2026-07-28: 0 catalysts2026-07-29: 0 catalysts2026-07-30: 0 catalysts2026-07-31: 0 catalysts2026-08-01: 0 catalysts2026-08-02: 0 catalysts2026-08-03: 4 catalysts2026-08-04: 13 catalysts2026-08-05: 17 catalysts2026-08-06: 10 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: 0 catalysts2026-08-15: 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 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 Sep 8, 2025

    50
    ›Sep 8, 2025device 510k328d 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 510k328d 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 510k328d 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 510k328d 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 510k328d 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 510k328d 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 510k328d 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 510k327d 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 510k327d agoBeckman Coulter, Inc. — Access anti-HAV (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 9, 2025device 510k327d 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 510k327d 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 510k327d 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 510k327d 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 510k327d 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 510k327d 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 510k327d 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 510k327d agoDGNCT, LLC — Segmentron Viewer (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 9, 2025device 510k327d 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 510k327d 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 510k327d 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 510k326d 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 510k326d agoMr Surgical Solutions, LLC — OptiVu™ Shoulder (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 10, 2025device 510k326d 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 510k326d agoBeckman Coulter, Inc. — iQ200 Series (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 10, 2025device 510k326d 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 510k326d 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 510k326d agoAngiowave Imaging, Inc. — AngioWaveNet (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 10, 2025device 510k326d agoPollogen, Ltd. — OptiLUV Device (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 10, 2025device 510k326d 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 510k325d 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 510k325d 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 510k325d 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 510k325d agoUroviu Corporation — UV5000 Handle (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 11, 2025device 510k325d 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 510k325d 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 510k325d 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 510k325d agoTns Co., Ltd. — Serafin® (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 11, 2025device 510k325d agoGe Medical Systems, LLC — SIGNA™ Sprint (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 11, 2025device 510k325d 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 510k325d 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 510k325d 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 510k325d 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 510k324d agoSparrow Acoustics, Inc. — Stethophone Pro (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 12, 2025device 510k324d 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 510k324d agoErchonia Corporation — Erchonia EVRL (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 12, 2025device 510k324d agoMedShape, Inc. — DynaNail TTC Fusion System (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 12, 2025device 510k324d 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 ↗
    ›Sep 12, 2025device 510k324d agoJupiter Endovascular — Vertex(TM) Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 12, 2025device 510k324d agoShanghai United Imaging Healthcare Co., Ltd. — uWS-Angio (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 12, 2025device 510k324d agoPollogen, Ltd. — Legend X Platform (510k cleared)

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

    full page →fda device 510k ↗
    ← prev
    page 63 of 100
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    $ISRG353.33+0.10%
    $FMS25.66-0.16%
    $TIMB
    $SNN30.25+5.29%
    $FRTRY
    $ISRG353.33+0.10%
    $FMS25.66-0.16%
    $MDCE0.00020.00%
    $FOFO3.0000+2.39%
    $MMSI85.01+1.99%
    $MDCE0.00020.00%
    $AAPL298.01+0.70%