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5,000 catalysts · 18,987 approval · 5,256 phase readout · 5,000 device 510k · 4,728 grant · 2,563 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: 3 catalysts2026-08-01: 0 catalysts2026-08-02: 0 catalysts2026-08-03: 4 catalysts2026-08-04: 13 catalysts2026-08-05: 16 catalysts2026-08-06: 10 catalysts2026-08-07: 1 catalyst2026-08-08: 0 catalysts2026-08-09: 0 catalysts2026-08-10: 1 catalyst2026-08-11: 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 readout5,256
  • device 510k5,000
  • grant4,728
  • 8k filing2,563
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • pdufa345
  • therapy area

    no tagged catalysts yet

    Week of Jul 21, 2025

    46
    ›Jul 22, 2025device 510k374d agoTalladium España, SL — Guided DAS Surgical Kit (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 22, 2025device 510k374d agoZhejiang Curaway Medical Technology Co., Ltd. — Disposable Biopsy Needle (510k cleared)Zhejiang Xinkanghe Biomedical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Jul 22, 2025device 510k374d agoLymphatech, Inc. — LymphaTech Mobile 3D Measuring Tool (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 22, 2025device 510k374d agoP.G.F. Industry Solutions GmbH — Granudacyn® Wound Irrigation Solution (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 22, 2025device 510k374d agoNeurospectrum Insights Corp. — GyriCalc (Version 1.0.0) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 22, 2025device 510k374d agoCanon Medical Systems Corporation — Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 22, 2025device 510k374d agoSuzhou Master Machinery Manufacturing Co.,Ltd — Mobility Scooter (MS160C) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 23, 2025device 510k373d 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 ↗
    ›Jul 23, 2025device 510k373d agoVitrolife Sweden AB — Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500); EmbryoCath Embryo Transfer Catheter - Straight Malleable 180 mm (REF 17501); EmbryoCath Embryo Transfer Catheter - Straight Malleable 230 mm (REF 17502); EmbryoCath Stylet - 180 mm (REF 17510); EmbryoCath Stylet - 230 mm (REF 17511) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 23, 2025device 510k373d agoXiamen Taotao Technology Co., Ltd. — Intermittent pressure compression system (Compression Pump PT1005A; Leg Compression Cuffs; L-1001S, L-1001L, L-1001XL, L-1001XXL, L-1001XXXL) (510k cleared)Xiamen Customized Elf Technology Co., Ltd.

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

    full page →fda device 510k ↗
    ›Jul 23, 2025device 510k373d agoCarbon Medical Technologies, Inc. — MammoSTAR Biopsy Site Identifier (510k cleared)Medical Care Technologies Inc.

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

    full page →fda device 510k ↗
    ›Jul 23, 2025device 510k373d agoInnovasis, Inc. — Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 23, 2025device 510k373d agoMerit Medical Systems, Inc. — Resilience Fully Covered Esophageal Stent System (510k cleared)MERIT MEDICAL SYSTEMS INC

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

    full page →fda device 510k ↗
    ›Jul 23, 2025device 510k373d agoStereotaxis, Inc. — MAGiC Sweep™ EP Mapping Catheter (510k cleared)Stereotaxis, Inc.

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

    full page →fda device 510k ↗
    ›Jul 23, 2025device 510k373d agoInfomed Software, S.L. — IMAGE ONE (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 23, 2025device 510k373d agoTerrats Medical SL — DESS® Dental Implants (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 23, 2025device 510k373d agoEdwards Lifesciences — HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere ClearSight Module (HEMCSM10); Smart Pressure Controller (PC1Q); Acumen IQ Plus Finger Cuff (AIQCA2); HemoSphere Pressure Cable (HEMPSC100); HemoSphere Vita Monitor (HEMVITA1); HemoSphere Vita Technology Module (HEMVTOM1); HemoSphere VitaWave module (HEMVWM1); VitaWave Plus finger cuff (VWCA2) (510k cleared)Edwards Lifesciences Corp

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

    full page →fda device 510k ↗
    ›Jul 23, 2025device 510k373d agoArum Dentistry Co., Ltd. — SD TL Implant System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 23, 2025device 510k373d agoOlea Medical S.A.S. — Neuro Insight V1.0 (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 24, 2025device 510k372d agoMedacta International S.A. — MOTO Partial Knee System Extension (510k cleared)Stemedica International S.A.

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

    full page →fda device 510k ↗
    ›Jul 24, 2025device 510k372d agoPhilips Ultrasound, LLC — EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 24, 2025device 510k372d agoShenzhen Ulike Smart Electronics Co., Ltd. — Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 24, 2025device 510k372d agoDentsply Sirona, Inc. — MIS LYNX Conical Connection Implant System (510k cleared)DENTSPLY SIRONA Inc.

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

    full page →fda device 510k ↗
    ›Jul 24, 2025device 510k372d agoInstrumentation Laboratory (IL) Co. — HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 24, 2025device 510k372d agoB.Braun Medical, Inc. — Infusomat® Space Volumetric Infusion Pump Administration Sets (510k cleared)B. Braun Medical Inc

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

    full page →fda device 510k ↗
    ›Jul 24, 2025device 510k372d agoAtriCure, Inc. — Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100) (510k cleared)AtriCure, Inc.

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

    full page →fda device 510k ↗
    ›Jul 24, 2025device 510k372d agoResponsive Respiratory — Respond OC Conserving Regulator (130-0800) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 24, 2025device 510k372d agoStryker Endoscopy — SPY Laparoscope (510k cleared)

    Product code: GCJ. Advisory committee: Gastroenterology, Urology. Type: Special

    full page →fda device 510k ↗
    ›Jul 24, 2025device 510k372d agoDavol Inc., Subsidiary of C. R. Bard, Inc. — Onflex™ Mesh (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 24, 2025device 510k372d agoWuxi Hisky Medical Technologies Co., Ltd. — Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System (BrightP960); Confocal Microprobe Imaging System (BrightP880); Confocal Microprobe Imaging System (BrightP860); Confocal Microprobe Imaging System (BrightP780); Confocal Microprobe Imaging System (BrightP750); Confocal Microprobe Imaging System (BrightP680); Confocal Microprobe Imaging System (BrightP660); Confocal Microprobe Imaging System (BrightP600); Confocal Microprobe Imaging System (BrightP580); (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 24, 2025device 510k372d agoTsk Laboratory, Japan — TSK SELECT™ Needle (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 25, 2025device 510k371d agoGuangdong Eda Technology Co., Ltd. — Heated Breathing Tube (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 25, 2025device 510k371d agoABBOTT MEDICAL — Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 25, 2025device 510k371d agoGuangzhou Longest Medical Technology Co., Ltd. — Compression Therapy Device (LGT-2210DS) (510k cleared)Guangzhou Dazhou Biomedical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Jul 25, 2025device 510k371d agoBecton Dickinson Infusion Therapy Systems, Inc. — BD Nexiva™ Closed IV Catheter System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 25, 2025device 510k371d agoHowmedica Osteonics Corp., Dba Stryker Orthopaedics — Triathlon® Hinge Knee System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 25, 2025device 510k371d agoKelyniam Global, Inc. — Fusion Craniofacial Implant; Fusion Skull Implant (510k cleared)Kelyniam Global, Inc.

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

    full page →fda device 510k ↗
    ›Jul 25, 2025device 510k371d agoHowmedica Osteonics Corp (Dba Stryker Orthopaedics) — Stryker and Serf hip devices (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 25, 2025device 510k371d agoHunan Vathin Medical Instrument Co., Ltd. — Vathin® Video Bronchoscope System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 25, 2025device 510k371d agoZhengzhou PZ Laser Slim Technology Co., Ltd. — Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 25, 2025device 510k371d agoLeo Cancer Care — Marie (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 25, 2025device 510k371d agoGE Medical Systems Ultrasound and Primary Care Diagnostics — Venue; Venue Go; Venue Fit; Venue Sprint (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 25, 2025device 510k371d agoCMT Health PTE., Ltd. — Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with Needle (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 25, 2025device 510k371d agoInbella Medical , Ltd. — InbellaMAX System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 25, 2025device 510k371d agoZimmer Biomet — A.L.P.S. Proximal Humerus Plating System (510k cleared)ZIMMER BIOMET HOLDINGS, INC.

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

    full page →fda device 510k ↗
    ›Jul 25, 2025device 510k371d agoGenesee Biomedical, Inc. — TransForm McCarthy Mitral Annuloplasty Ring (TF) (510k cleared)RNR BioMedical Inc

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

    full page →fda device 510k ↗

    Week of Jul 28, 2025

    4
    ›Jul 28, 2025device 510k368d agoInfinitum Eta, Ltd. — NUVENTUS NV.C™ Prosthetic Components (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 28, 2025device 510k
    ← prev
    page 55 of 100
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    368d ago
    Changsha Anxiang Medical Technology Co., Ltd. — 3 in 1 TENS UNIT (TC1241, TC2241, TS1241) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 28, 2025device 510k368d agoSeum Medi Co., Ltd. — ISO Abutment (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 28, 2025device 510k368d agoAnumana, Inc. — ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) (510k cleared)

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

    full page →fda device 510k ↗
    $KLYG
    $ATRC
    $XRAY13.74-3.24%
    $STXS1.8800+5.62%
    $EW91.33-2.47%
    $ISRG352.97-0.04%
    $MDCE0.00020.00%
    $JLZQ
    $MMSI83.35+3.10%
    $ZBH87.97+0.93%