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5,000 catalysts · 18,987 approval · 5,063 phase readout · 5,000 device 510k · 4,728 grant · 2,469 8k filing · 2,000 device pma

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2026-07-27: 0 catalysts2026-07-28: 0 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 filing2,469
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • pdufa319
  • therapy area

    no tagged catalysts yet

    Week of May 19, 2025

    41
    ›May 21, 2025device 510k434d agoFinemedix Co., Ltd. — ClearHemograsper (510k cleared)

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

    full page →fda device 510k ↗
    ›May 21, 2025device 510k434d agoPhilips Ultrasound, LLC — EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 21, 2025device 510k434d agoInVision Medical Technology Corporation — InVision Precision Cardiac Amyloid (510k cleared)

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

    full page →fda device 510k ↗
    ›May 21, 2025device 510k434d agoAnx Robotica Corporation — MotiliCap GI Monitoring System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 21, 2025device 510k434d agoAlma Lasers, Inc. — The Alma Hybrid Laser System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 22, 2025device 510k433d agoBasic Medical Technology, Inc. — Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate (510k cleared)Medical Care Technologies Inc.

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

    full page →fda device 510k ↗
    ›May 22, 2025device 510k433d agoHua Yue Medical Technology Co., Ltd. — Harioculture TL-16 Time-lapse Incubator (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›May 22, 2025device 510k433d agoUrotronic, Inc. — Optilume® High Pressure Urological Balloon Dilation Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›May 22, 2025device 510k433d agoClinical Innovations, LLC — Koala Intrauterine Pressure Catheter (IPC-5000E) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 22, 2025device 510k433d agoTriMed, Inc. — TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System (Fifth Metatarsal Screw) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 22, 2025device 510k433d agoOrtho Development Corp. — Trivicta® Hip Stem (510k cleared)DeFi Development Corp.

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

    full page →fda device 510k ↗
    ›May 22, 2025device 510k433d agoCryoconcepts LP — Skin Clinic Freeze Point for Warts and Skin Tags (510k cleared)

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

    full page →fda device 510k ↗
    ›May 22, 2025device 510k433d agoRandox Laboratories, Ltd. — ConcizuTrace™ ELISA (510k cleared)Rafa Laboratories Co Ltd

    Product code: SES. Advisory committee: Hematology. Type: Direct

    full page →fda device 510k ↗
    ›May 22, 2025device 510k433d agoArthrex, Inc. — Arthrex Spine Compression FT Screw (510k cleared)

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

    full page →fda device 510k ↗
    ›May 22, 2025device 510k433d agoOvesco Endoscopy AG — ArgoCap (200.52) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 22, 2025device 510k433d agoJiangsu Yuyue Medical Equipment & Supply Co., Ltd. — YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 22, 2025device 510k433d agoTerrats Medical SL — DESS Dental Smart Solutions (510k cleared)

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

    full page →fda device 510k ↗
    ›May 22, 2025device 510k433d agoLima Corporate S.P.A. — Physica System (Physica CR Porous Femoral components) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 22, 2025device 510k433d agoThermo Fisher Scientific — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mL (510k cleared)THERMO FISHER SCIENTIFIC INC.

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

    full page →fda device 510k ↗
    ›May 22, 2025device 510k433d agoShenzhen Kaiyan Medical Equipment Co., Ltd. — Solawave 2-in-1 Skincare Mini (Model: 61043) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k432d agoPearl, Inc. — Second Opinion® 3D (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k432d agoPiraeus Medical — 93 NeuFlex Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k432d agoKuros Biosciences B.V — MagnetOs MIS (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k432d agoGeske Beauty Tech GmbH — SmartAppGuidedTM MicroCurrent Face-Lift Pen 6 in 1 (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k432d agoShenzhen Ulike Smart Electronics Co., Ltd. — Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 GR, MI01 PP, MI01 RM, MI01 WG, MI01 WH, MI01 BK;UI04S PP, UI04S BU, UI04S WH, UI04S PN) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k432d agoLVIS Corporation — NeuroMatch (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k432d agoThe Binding Site Group , Ltd. — Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit (510k cleared)Dawn Sea Therapeutics

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k432d agoEizo Corporation — RadiForce MX317W-PA (510k cleared)

    Product code: PZZ. Advisory committee: Pathology. Type: Abbreviated

    full page →fda device 510k ↗
    ›May 23, 2025device 510k432d agoEwoosoft Co., Ltd. — Clever One (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k432d agoDepuy Ireland UC — RECLAIM Monobloc Revision Femoral Stem (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k432d agoEl Global Trade, Ltd. — IPL400 (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k432d agoSpineup, Inc. — Frida™ Anterior Cervical Plate System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k432d agoWellell, Inc. — WiZARD 520 Full Face Mask (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k432d agoABBOTT MEDICAL — ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid Mapping Catheter, Sensor Enabled™; Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™; Agilis™ NxT Steerable Introducer; Agilis™ NxT Steerable Introducer Dual-Reach™ (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k432d agoVenocare, Inc. — Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k432d agoDsi Dental Solutions, Ltd. — Sil-Flow (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k432d agoRivanna Medical, Inc. — Accuro 3S (510k cleared)Vivani Medical, Inc.

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k432d agoBrain Navi Biotechnology Co., Ltd. — Stereotaxic Guiding Surgical Devices, NaoTrac S (510k cleared)Avistone Biotechnology Co Ltd

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k432d agoFujifilm Corporation — FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L (510k cleared)Fujifilm Holdings Corp

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k432d agoDeepecho — DEEPECHO (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k432d agoStryker Endoscopy — Knotilus+ Biocomposite Knotless Anchor (510k cleared)

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

    full page →fda device 510k ↗

    Week of May 26, 2025

    9
    ›May 27, 2025device 510k428d agoPuritan Medical Products, LLC — Puritan PurSafe Plus Collection and Transport System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 27, 2025device 510k
    ← prev
    page 43 of 100
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    428d ago
    Distalmotion SA — Dexter L6 System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 27, 2025device 510k428d agoPreventamed Technologies, Inc. Dba Surfacide Manufacturing — Helios+ UV-C System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 27, 2025device 510k428d agoNingbo Baichen Medical Devices Co., Ltd. — Electric Wheelchair (BC-EA5516, BC-EC8002, BC-EC8003, BC-EALD3) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 27, 2025device 510k428d agoOSSIO , Ltd. — OSSIOfiber® Suture Anchor (510k cleared)

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

    full page →fda device 510k ↗
    ›May 27, 2025device 510k428d agoMedicalgorithmics S.A. — DeepRhythmAI (510k cleared)

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

    full page →fda device 510k ↗
    ›May 27, 2025device 510k428d agoJjgc Indústria E Comércia DE Materiais Dentários S.A. — Neodent Implant System - Custom Abutments (510k cleared)

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

    full page →fda device 510k ↗
    ›May 27, 2025device 510k428d agoTheodent, LLC — Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Varnish (3% / Cherry); Rennou™ Varnish (3% / Bubble Gum) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 27, 2025device 510k428d agoShofu Dental Corporation — BEAUTIFIL II (510k cleared)

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

    full page →fda device 510k ↗
    $DFUKF
    $MDCE0.00020.00%
    $VANI1.6000+18.52%
    $TMO447.81+1.31%