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3,058 catalysts · 4,728 grant · 3,603 8k filing · 3,058 device 510k · 2,773 approval · 2,000 device pma · 2,000 device recall

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type: device 510k×from 2025-05-05×clear all
type
  • grant4,728
  • 8k filing3,603
  • device 510k3,058
  • approval2,773
  • device pma2,000
  • device recall2,000
device adverse event
1,000
  • recall751
  • earnings585
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of May 5, 2025

    50
    ›May 5, 2025device 510k483d agoZamar Medical D.O.O. — ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 5, 2025device 510k483d agoAevice Health Pte. , Ltd. — AeviceMD (510k cleared)

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

    full page →fda device 510k ↗
    ›May 5, 2025device 510k483d agoGenoss Co., Ltd. — Bluemoon (510k cleared)

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

    full page →fda device 510k ↗
    ›May 5, 2025device 510k483d agoPhilips Medizin Systeme Böblingen GmbH — Telemetry Monitor 5500 Release 4.0 (867232) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 5, 2025device 510k483d agoThermasolutions, LLC — ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 5, 2025device 510k483d agoPearl, Inc. — Second Opinion® Pediatric (510k cleared)

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

    full page →fda device 510k ↗
    ›May 5, 2025device 510k483d agoAsiga Pty, Ltd. — DentaTOOTH (510k cleared)

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

    full page →fda device 510k ↗
    ›May 5, 2025device 510k483d agoArthrex, Inc. — Arthrex Synergy Vision Endoscopic Imaging System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 5, 2025device 510k483d 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 510k482d agoMentice Spain S.L. — ANKYRAS (510k cleared)

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

    full page →fda device 510k ↗
    ›May 6, 2025device 510k482d 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 510k482d agoSolutions For Tomorrow AB — !M1 (510k cleared)

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

    full page →fda device 510k ↗
    ›May 6, 2025device 510k482d 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 510k482d 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 510k482d 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 510k481d 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 510k481d 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 510k481d agoExcitus AS — Cary (510k cleared)

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

    full page →fda device 510k ↗
    ›May 7, 2025device 510k481d 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 510k481d 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 510k481d agoBrightheart — BrightHeart View Classifier (510k cleared)

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

    full page →fda device 510k ↗
    ›May 8, 2025device 510k480d 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 510k480d 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 510k480d agoPreat Corporation — Preat Abutments (510k cleared)

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

    full page →fda device 510k ↗
    ›May 8, 2025device 510k480d 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 510k480d 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 510k480d 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 510k480d 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 510k480d 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 510k480d 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 510k480d 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 510k480d 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 510k480d 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 510k479d 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 510k479d 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 510k479d 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 510k479d agoAltaviz, LLC — Altaviz Intravitreal Syringe (510k cleared)

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

    full page →fda device 510k ↗
    ›May 9, 2025device 510k479d 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 510k479d 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 510k479d agoAvidhrt, Inc. — Avidhrt Sense SpO2 (510k cleared)

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

    full page →fda device 510k ↗
    ›May 9, 2025device 510k479d agoMectron S.P.A. — turbodent touch (510k cleared)

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

    full page →fda device 510k ↗
    ›May 9, 2025device 510k479d 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 510k479d agoPearl, Inc. — Second Opinion® BLE (510k cleared)

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

    full page →fda device 510k ↗
    ›May 9, 2025device 510k479d agoVolta Medical — Volta AF-Xplorer (510k cleared)

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

    full page →fda device 510k ↗
    ›May 9, 2025device 510k479d agoTristel Solutions , Ltd. — Tristel OPH (510k cleared)

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

    full page →fda device 510k ↗
    ›May 9, 2025device 510k479d 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 510k479d 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 510k479d 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 510k479d 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 510k479d agoCrossroads Neurovascular, Inc. — PATH BGC (510k cleared)PATH

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

    full page →fda device 510k ↗
    ← prev
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    $VIOT
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