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5,000 catalysts · 18,987 approval · 5,063 phase readout · 5,000 device 510k · 4,728 grant · 2,460 8k filing · 2,000 device pma

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2026-07-27: 0 catalysts2026-07-28: 21 catalysts2026-07-29: 12 catalysts2026-07-30: 12 catalysts2026-07-31: 3 catalysts2026-08-01: 0 catalysts2026-08-02: 0 catalysts2026-08-03: 4 catalysts2026-08-04: 12 catalysts2026-08-05: 14 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: 0 catalysts2026-08-14: 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: 0 catalysts2026-10-22: 1 catalyst2026-10-23: 0 catalysts2026-10-24: 0 catalysts2026-10-25: 0 catalysts
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type: device 510k×clear all
type
  • approval18,987
  • phase readout5,063
  • device 510k5,000
  • grant4,728
  • 8k filing2,460
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • earnings296
  • therapy area

    no tagged catalysts yet

    Week of May 5, 2025

    47
    ›May 5, 2025device 510k450d agoDae Myung Chemical Co., Ltd. (Vietnam) — Dream Medi Sterile Surgical Gown (SurgicalGownUL) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 6, 2025device 510k449d agoMentice Spain S.L. — ANKYRAS (510k cleared)

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

    full page →fda device 510k ↗
    ›May 6, 2025device 510k449d agoWontech Co., Ltd. — Alma Veil (510k cleared)

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

    full page →fda device 510k ↗
    ›May 6, 2025device 510k449d agoSolutions For Tomorrow AB — !M1 (510k cleared)

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

    full page →fda device 510k ↗
    ›May 6, 2025device 510k449d agoHunan Vathin Medical Instrument Co., Ltd. — Single-use Flexible Ureteroscope (510k cleared)

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

    full page →fda device 510k ↗
    ›May 6, 2025device 510k449d agoFoshan Newface Electronic Technology Co., Ltd. — IPL Hair Removal Device (NV-TM10A, NV-TM10C, NV-TM10D) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 6, 2025device 510k449d agoDongguan Boyuan Intelligent Technology Co.,Ltd — IPL Hair Removal Device (KCA511/KCA516/KCA522) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 7, 2025device 510k448d agoExtremity Medical, LLC — Extremity Medical External Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 7, 2025device 510k448d agoBelport Company, Inc., Gingi-Pak — SDF Pro (510k cleared)

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

    full page →fda device 510k ↗
    ›May 7, 2025device 510k448d agoExcitus AS — Cary (510k cleared)

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

    full page →fda device 510k ↗
    ›May 7, 2025device 510k448d agoZeus Scientific — Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed) (510k cleared)Dawn Sea Therapeutics

    Product code: MOB. Advisory committee: Immunology. Type: Traditional

    full page →fda device 510k ↗
    ›May 7, 2025device 510k448d agoWuyi Aichi Industry & Trade Co., Ltd. — Mobility Scooter (Model X-01, X-02) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 7, 2025device 510k448d agoBrightheart — BrightHeart View Classifier (510k cleared)

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

    full page →fda device 510k ↗
    ›May 8, 2025device 510k447d agoAltus Partners, LLC — Altus Spine Navigation System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 8, 2025device 510k447d agoWuhan Pioon Technology Co., Ltd. — Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 8, 2025device 510k447d agoPreat Corporation — Preat Abutments (510k cleared)

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

    full page →fda device 510k ↗
    ›May 8, 2025device 510k447d agoNextstep Arthropedix — NextStep Arthropedix Total Knee System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 8, 2025device 510k447d agoPhilips Ultrasound — Lumify Diagnostic Ultrasound System (510k cleared)Ocuvex Therapeutics Inc

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

    full page →fda device 510k ↗
    ›May 8, 2025device 510k447d agoTelesair, Inc. — AVEA disposable expiratory filter/water trap (11790) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 8, 2025device 510k447d agoSuntech UK , Ltd. — eFOLDi Navigator Powerchair (STPC-A) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 8, 2025device 510k447d agoSynoross Dba Osseone — OsseOne Dental Implant System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 8, 2025device 510k447d agoFissiontech, LLC — Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 Blue (510k cleared)

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

    full page →fda device 510k ↗
    ›May 8, 2025device 510k447d agoClarius Mobile Health Corp. — Clarius Median Nerve AI (510k cleared)

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

    full page →fda device 510k ↗
    ›May 8, 2025device 510k447d agoLeltek, Inc. — Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series); Ultrasound Imaging System (LX Series) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 8, 2025device 510k447d agoCG Bio Co., Ltd. — COLONNADE Posterior Screw Fixation System (510k cleared)3H Bio Co Ltd

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

    full page →fda device 510k ↗
    ›May 9, 2025device 510k446d agoChangshu Pingfang Wheelchair Co., Ltd. — Electric Wheelchair (F309) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 9, 2025device 510k446d agoPhilips Ultrasound, LLC — EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems (510k cleared)

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

    full page →fda device 510k ↗
    ›May 9, 2025device 510k446d agoBTL Industries, Inc. — BTL-785MJ (510k cleared)NL INDUSTRIES INC

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

    full page →fda device 510k ↗
    ›May 9, 2025device 510k446d agoAltaviz, LLC — Altaviz Intravitreal Syringe (510k cleared)

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

    full page →fda device 510k ↗
    ›May 9, 2025device 510k446d agoVigeon Technology Co., Ltd. — Vigeon Laparoscopic Universal Smoke Evacuator (VG003) (510k cleared)Viomi Technology Co., Ltd

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

    full page →fda device 510k ↗
    ›May 9, 2025device 510k446d agoCapillary Biomedical, LLC — SteadiSet Infusion Set (510k cleared)

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

    full page →fda device 510k ↗
    ›May 9, 2025device 510k446d agoAvidhrt, Inc. — Avidhrt Sense SpO2 (510k cleared)

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

    full page →fda device 510k ↗
    ›May 9, 2025device 510k446d agoMectron S.P.A. — turbodent touch (510k cleared)

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

    full page →fda device 510k ↗
    ›May 9, 2025device 510k446d agoTeal Health, Inc. — Teal Wand (510k cleared)Health In Tech, Inc.

    Product code: SEP. Advisory committee: Microbiology. Type: Direct

    full page →fda device 510k ↗
    ›May 9, 2025device 510k446d agoPearl, Inc. — Second Opinion® BLE (510k cleared)

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

    full page →fda device 510k ↗
    ›May 9, 2025device 510k446d agoVolta Medical — Volta AF-Xplorer (510k cleared)

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

    full page →fda device 510k ↗
    ›May 9, 2025device 510k446d agoTristel Solutions , Ltd. — Tristel OPH (510k cleared)

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

    full page →fda device 510k ↗
    ›May 9, 2025device 510k446d agoDongguan Yanxuan Biotechnology Co., Ltd. — Water Solubility Human Body Lubricant (510k cleared)Cellyan Biotechnology Co., Ltd

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

    full page →fda device 510k ↗
    ›May 9, 2025device 510k446d agoVarian Medical Systems, Inc. — CT/ MR Tandem and Ovoid Set (510k cleared)MERIT MEDICAL SYSTEMS INC

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

    full page →fda device 510k ↗
    ›May 9, 2025device 510k446d agoDiasys Diagnostic Systems GmbH — DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls (510k cleared)

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

    full page →fda device 510k ↗
    ›May 9, 2025device 510k446d agoShenzhen Jiantuo Electronics Co., Ltd. — TENS AND EMS (TENS and Muscle Stimulator) (JT8012, JT8012B) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 9, 2025device 510k446d agoCrossroads Neurovascular, Inc. — PATH BGC (510k cleared)PATH

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

    full page →fda device 510k ↗
    ›May 9, 2025device 510k446d agoIterative Health — SKOUT system (510k cleared)

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

    full page →fda device 510k ↗
    ›May 9, 2025device 510k446d agoPhilips Image Guided Therapy Corporation — VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 9, 2025device 510k446d agoBonraybio Co., Ltd. — LensHooke X12 PRO Semen Analysis System (510k cleared)

    Product code: POV. Advisory committee: Hematology. Type: Traditional

    full page →fda device 510k ↗
    ›May 10, 2025device 510k445d agoACON Laboratories, Inc. — Flowflex Plus COVID-19 + Flu A/B Home Test (510k cleared)Alcon Laboratories Inc

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

    full page →fda device 510k ↗
    ›May 11, 2025device 510k444d agoShenzhen Jiantuo Electronics Co., Ltd. — TENS AND EMS (TENS and Muscle Stimulator) (JT8012C,JT8016,JT9020E,JT9026) (510k cleared)

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

    full page →fda device 510k ↗

    Week of May 12, 2025

    3
    ›May 12, 2025device 510k443d agoNortheast Scientific, Inc. — NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 12, 2025device 510k
    ← prev
    page 40 of 100
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    443d ago
    United Zirconia — ZircaGlow & ZircaGlow HT Zirconia (510k cleared)

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

    full page →fda device 510k ↗
    ›May 12, 2025device 510k443d agoShandong Moonlight Electronics Tech Co., Ltd. — Medical Diode Laser Hair Removal System (MNLT-D1) (510k cleared)

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

    full page →fda device 510k ↗
    $NL6.0500-1.14%
    $HKPD
    $MMSI76.10+2.40%
    $VIOT
    $HIT