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3,076 catalysts · 4,728 grant · 3,076 device 510k · 3,045 8k filing · 2,774 approval · 2,000 device pma · 2,000 device recall

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2026-08-10: 0 catalysts2026-08-11: 16 catalysts2026-08-12: 19 catalysts2026-08-13: 19 catalysts2026-08-14: 4 catalysts2026-08-15: 0 catalysts2026-08-16: 0 catalysts2026-08-17: 1 catalyst2026-08-18: 2 catalysts2026-08-19: 2 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: 1 catalyst2026-08-27: 1 catalyst2026-08-28: 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: 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: 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: 8 catalysts2026-11-03: 17 catalysts2026-11-04: 22 catalysts2026-11-05: 36 catalysts2026-11-06: 2 catalysts2026-11-07: 0 catalysts2026-11-08: 0 catalysts
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type: device 510k×from 2025-05-02×clear all
type
  • grant4,728
  • device 510k3,076
  • 8k filing3,045
  • approval2,774
  • device pma2,000
  • device recall2,000
device adverse event
1,000
  • recall751
  • earnings579
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Apr 28, 2025

    18
    ›May 2, 2025device 510k466d agoPfm Medical, Inc. — JetCan® Pro Safety Huber Needle (510k cleared)Picard Medical, Inc.

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

    full page →fda device 510k ↗
    ›May 2, 2025device 510k466d agoShockwave Medical, Inc. — Shockwave CS Guide Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›May 2, 2025device 510k466d agoHathor Professional Skincare , Ltd. — Sutil Rich Personal Lubricant (510k cleared)

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

    full page →fda device 510k ↗
    ›May 2, 2025device 510k466d agoSignature Orthopaedics Pty, Ltd. — Origin™ Cemented Hip Stem (510k cleared)

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

    full page →fda device 510k ↗
    ›May 2, 2025device 510k466d agoBeijing Rongrui-Century Science & Technology Co., Ltd. — SpO2 Extension Cable (510k cleared)

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

    full page →fda device 510k ↗
    ›May 2, 2025device 510k466d agoAbbott Point of Care, Inc. — i-STAT CG4+ cartridge with the i-STAT 1 System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 2, 2025device 510k466d agoSg Endoscopy Pte, Ltd. — F88 URE-SD/RD Flexible Ureteroscope (510k cleared)

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

    full page →fda device 510k ↗
    ›May 2, 2025device 510k466d agoSTERIS Corporation — Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 (510k cleared)STERIS plc

    Product code: JOJ. Advisory committee: General Hospital. Type: Special

    full page →fda device 510k ↗
    ›May 2, 2025device 510k466d agoSeriously Clean, Ltd. — Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel (510k cleared)

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

    full page →fda device 510k ↗
    ›May 2, 2025device 510k466d agoAtsens Co., Ltd. — AT-Patch (ATP-C130/ATP-C70) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 2, 2025device 510k466d agoMedical Electronic Systems , Ltd. — SQA-iOw Sperm Quality Analyzer (510k cleared)

    Product code: POV. Advisory committee: Hematology. Type: Dual Track

    full page →fda device 510k ↗
    ›May 2, 2025device 510k466d agoCionic, Inc. — CIONIC NEURAL SLEEVE (NS-200) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 2, 2025device 510k466d agoSkydance Vascular, Inc. — OSPREY Midline Closed IV Catheter System (OspreyEDC-F20) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 2, 2025device 510k466d agoIntradys — LUMYS (V1) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 2, 2025device 510k466d agoShenzhen AOJ Medical Technology Co., Ltd. — Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood Pressure Monitor (AOJ-35B); Wrist Blood Pressure Monitor (WRS-35B); Wrist Blood Pressure Monitor (AOJ-35D); Wrist Blood Pressure Monitor (AOJ-35E); Wrist Blood Pressure Monitor (AOJ-35F); Wrist Blood Pressure Monitor (AOJ-35G); Wrist Blood Pressure Monitor (WRS-35G); Wrist Blood Pressure Monitor (WRS-35H); Wrist Blood Pressure Monitor (WRS-35K); Wrist Blood Pressure Monitor (WRS-35N); Wrist Blood Pressure Monitor (WRS-35P); Wrist Bloo (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›May 2, 2025device 510k466d agoKarl Storz SE & CO. KG — KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 2, 2025device 510k466d agoBrightheart — Fetal EchoScan (v1.1) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 2, 2025device 510k466d agoMomentis Surgical , Ltd. — Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook Electrode (510k cleared)

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

    full page →fda device 510k ↗

    Week of May 5, 2025

    32
    ›May 5, 2025device 510k463d 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 510k
    ← prev
    page 1 of 62
    next →
    463d ago
    Aevice Health Pte. , Ltd. — AeviceMD (510k cleared)

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

    full page →fda device 510k ↗
    ›May 5, 2025device 510k463d agoGenoss Co., Ltd. — Bluemoon (510k cleared)

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

    full page →fda device 510k ↗
    ›May 5, 2025device 510k463d 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 510k463d 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 510k463d agoPearl, Inc. — Second Opinion® Pediatric (510k cleared)

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

    full page →fda device 510k ↗
    ›May 5, 2025device 510k463d agoAsiga Pty, Ltd. — DentaTOOTH (510k cleared)

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

    full page →fda device 510k ↗
    ›May 5, 2025device 510k463d 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 510k463d 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 510k462d agoMentice Spain S.L. — ANKYRAS (510k cleared)

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

    full page →fda device 510k ↗
    ›May 6, 2025device 510k462d 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 510k462d agoSolutions For Tomorrow AB — !M1 (510k cleared)

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

    full page →fda device 510k ↗
    ›May 6, 2025device 510k462d 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 510k462d 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 510k462d 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 510k461d 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 510k461d 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 510k461d agoExcitus AS — Cary (510k cleared)

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

    full page →fda device 510k ↗
    ›May 7, 2025device 510k461d 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 510k461d 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 510k461d agoBrightheart — BrightHeart View Classifier (510k cleared)

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

    full page →fda device 510k ↗
    ›May 8, 2025device 510k460d 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 510k460d 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 510k460d agoPreat Corporation — Preat Abutments (510k cleared)

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

    full page →fda device 510k ↗
    ›May 8, 2025device 510k460d 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 510k460d 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 510k460d 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 510k460d 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 510k460d 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 510k460d 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 510k460d 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 510k460d 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 ↗
    $PMI0.1821-4.66%
    $STE238.91+0.61%