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3,682 catalysts · 4,728 grant · 3,682 device 510k · 3,230 8k filing · 2,977 approval · 2,000 device pma · 2,000 device recall

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2026-08-10: 0 catalysts2026-08-11: 0 catalysts2026-08-12: 0 catalysts2026-08-13: 60 catalysts2026-08-14: 4 catalysts2026-08-15: 0 catalysts2026-08-16: 0 catalysts2026-08-17: 1 catalyst2026-08-18: 2 catalysts2026-08-19: 3 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: 9 catalysts2026-11-03: 18 catalysts2026-11-04: 22 catalysts2026-11-05: 37 catalysts2026-11-06: 2 catalysts2026-11-07: 0 catalysts2026-11-08: 0 catalysts
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type: device 510k×from 2025-02-24×clear all
type
  • grant4,728
  • device 510k3,682
  • 8k filing3,230
  • approval2,977
  • device pma2,000
  • device recall2,000
device adverse event
1,000
  • recall915
  • earnings584
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Feb 24, 2025

    50
    ›Feb 24, 2025device 510k536d agoAnqing Clean Dental Instrument Technology Co., Ltd. — Sterilization Package/Reel (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 24, 2025device 510k536d agoLingshi Hongruida Health Protection Technology Co., Ltd. — Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs (510k cleared)Teva Pharmaceuticals USA Inc

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

    full page →fda device 510k ↗
    ›Feb 24, 2025device 510k536d agoArum Dentistry Co., Ltd. — SD Implant System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 24, 2025device 510k536d agoAlembic, LLC — APRO 70 Swift Catheter and Alembic Aspiration Tubing (510k cleared)Alembic Pharmaceuticals Inc

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

    full page →fda device 510k ↗
    ›Feb 24, 2025device 510k536d agoJpi Healthcare Co, Ltd. — ExamVue Apex (510k cleared)NVP Healthcare Co Ltd

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

    full page →fda device 510k ↗
    ›Feb 24, 2025device 510k536d agoTandem Diabetes Care, Inc. — Control-IQ+ technology (510k cleared)TANDEM DIABETES CARE INC

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

    full page →fda device 510k ↗
    ›Feb 24, 2025device 510k536d agoOncosoft. Co., Ltd. — OncoStudio (OS-01) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 24, 2025device 510k536d agoUlthera, Inc. — Ulthera® System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 25, 2025device 510k535d agoGE Medical Systems SCS — 3DXR (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 25, 2025device 510k535d agoTaiwan Aulisa Medical Devices Technologies, Inc. — Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 25, 2025device 510k535d agoFitbit — Loss of Pulse Detection (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 25, 2025device 510k535d agoAbanza Tecnomed S.L — WasherCap™ Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 25, 2025device 510k535d agoCpmt Laser (Canadian Pioneer Medical Technology Corporation) — EMS (FlexPulse, MagnaCore, Magnetika) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 25, 2025device 510k535d agoTherapanacea Sas — ART-Plan+ (v.3.0.0) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 25, 2025device 510k535d agoEthicon Endo-Surgery, LLC — ECHELON LINEAR™ Stapler 30mm Stapler (GTX30); ECHELON LINEAR™ Stapler 60mm Stapler (GTX60); ECHELON LINEAR™ Stapler 90mm Stapler (GTX90); ECHELON LINEAR™ Stapler 3D 30mm Blue Reload (GTXR30B); ECHELON LINEAR™ Stapler 3D 30mm Green Reload (GTXR30G); ECHELON LINEAR™ Stapler 3D 60mm Blue Reload (GTXR60B); ECHELON LINEAR™ Stapler 3D 60mm Green Reload (GTXR60G); ECHELON LINEAR™ Stapler 3D 90mm Blue Reload (GTXR90B); ECHELON LINEAR™ Stapler 3D 90mm Green Reload (GTXR90G) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 25, 2025device 510k535d agoJLK, Inc. — JLK-AILink (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 25, 2025device 510k535d agoPrismatik Dentalcraft, Inc. — BruxZir® Esthetic NOW (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 26, 2025device 510k534d agoInfraredx, Inc. — Makoto Intravascular Imaging System™ (VC-MC10 / TVC-MC10i); Dualpro™ IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 ) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 26, 2025device 510k534d agoInquis Medical — Aventus Thrombectomy System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 26, 2025device 510k534d agoPerfuze, Ltd. — Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 26, 2025device 510k534d agoEl.En S.P.A. — DEKA LOTUS (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 26, 2025device 510k534d agoSteriLance Medical (Suzhou), Inc. — Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 26, 2025device 510k534d agoSteriLance Medical (Suzhou), Inc. — Heel Incision Safety Lancet (SteriHeel 2) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 26, 2025device 510k534d agoVygon Corporation — pilot TLS (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 26, 2025device 510k534d agoVentripoint Diagnostics , Ltd. — Ventripoint Medical System Plus (VMS+) 4.0 (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 26, 2025device 510k534d agoElute, Inc. — BonVie+ (510k cleared)ELUTIA INC.

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

    full page →fda device 510k ↗
    ›Feb 26, 2025device 510k534d agoMedline Industries, LP — Medline Level 4 Surgical Gown with Breathable Sleeves (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 26, 2025device 510k534d agoFovia, Inc. — aiCockpit AI Viewer (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 26, 2025device 510k534d agoMaquet Cardiovascular, LLC — Vasoview Hemopro 3 Power Supply (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 27, 2025device 510k533d agoNanofiber Solutions, LLC — Rotium (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 27, 2025device 510k533d agoVeol Medical Technologies Pvt , Ltd. — EzVu Visual Vasopressor injector (EV-19) (510k cleared)KESTRA MEDICAL TECHNOLOGIES, LTD.

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

    full page →fda device 510k ↗
    ›Feb 27, 2025device 510k533d agoXod, Inc. — XOD Diathermia Radiofrequency Device (510k cleared)Xos, Inc.

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

    full page →fda device 510k ↗
    ›Feb 27, 2025device 510k533d agoGleamer Sas — ChestView US (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 27, 2025device 510k533d agoVascutek, Ltd. — Gelweave™ Vascular Prostheses (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 27, 2025device 510k533d agoIline Microsystems, S.L. — microINR System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 27, 2025device 510k533d agoIcotec AG — VADER® Pedicle System and VADER®one Pedicle System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 27, 2025device 510k533d agoHangzhou AllTest Biotech Co., Ltd. — AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup (510k cleared)Hangzhou DAC Biotech Co Ltd

    Product code: NFT. Advisory committee: Clinical Toxicology. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 27, 2025device 510k533d agoXaga Surgical — Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 27, 2025device 510k533d agoBecton Dickinson Infusion Therapy Systems, Inc. — PIVO™ Pro Needle-free Blood Collection Device (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 27, 2025device 510k533d agoThermo Fisher Scientific — The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL (510k cleared)THERMO FISHER SCIENTIFIC INC.

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

    full page →fda device 510k ↗
    ›Feb 27, 2025device 510k533d agoL&K BIOMED Co., Ltd. — CastleLoc Pectus Bar System (510k cleared)NeuCen BioMed Co Ltd

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

    full page →fda device 510k ↗
    ›Feb 27, 2025device 510k533d agoBrosmed Medical Co., Ltd. — Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 28, 2025device 510k532d agoRb Health (Us), LLC — Durex Polyisoprene Condom (510k cleared)Bausch Health US LLC

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

    full page →fda device 510k ↗
    ›Feb 28, 2025device 510k532d agoGt Metabolic Solutions, Inc. — MagDI System (MAG-02, DS-01) (510k cleared)Seed Health Inc

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

    full page →fda device 510k ↗
    ›Feb 28, 2025device 510k532d agoBasis Medical — Seclusion Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 28, 2025device 510k532d agoQingdao Kingon Medical Science and Technology Co., Ltd. — Portable Oxygen Concentrator (P2-TOC) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 28, 2025device 510k532d agoPhenox Limited — pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device (510k cleared)

    Product code: POL. Advisory committee: Neurology. Type: Special

    full page →fda device 510k ↗
    ›Feb 28, 2025device 510k532d agoShandon Diagnostics Limited — E1000 Dx Digital Pathology Solution (510k cleared)

    Product code: PSY. Advisory committee: Pathology. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 28, 2025device 510k532d agoBaxter Healthcare Corporation — Intravascular Extension Sets and Accessories (510k cleared)Baxter Healthcare Corp

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

    full page →fda device 510k ↗
    ›Feb 28, 2025device 510k532d agoFresenius Medical Care Renal Therapies Group, LLC — FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX CorAL 120 (F00012972); FX CorAL 600 (F00012973); FX CorAL 800 (F00012974); FX CorAL 1000 (F00012975) (510k cleared)Fresenius Medical Care AG

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

    full page →fda device 510k ↗
    ← prev
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    $TMO447.81+1.31%
    $ELUT
    $TNDM23.440.00%
    $KMTS20.35+8.13%
    $XOSWW
    $FMS23.92+0.84%