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5,000 catalysts · 18,987 approval · 5,000 device 510k · 4,876 phase readout · 4,728 grant · 2,415 8k filing · 2,000 device pma

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type: device 510k×clear all
type
  • approval18,987
  • device 510k5,000
  • phase readout4,876
  • grant4,728
  • 8k filing2,415
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • earnings295
  • therapy area

    no tagged catalysts yet

    Week of Feb 17, 2025

    18
    ›Feb 21, 2025device 510k521d agoExtremity Medical, LLC — Extremity Medical External Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k521d agoScandiags AG — ScanDiags Ortho L-Spine MR-Q (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k521d agoChurch & Dwight Co., Inc. — Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy) (510k cleared)CHURCH & DWIGHT CO INC /DE/

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k521d agoIntradin (Shanghai) Machinery Co., Ltd. — Powered Mobility Scooter (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k521d agoVATECH Co., Ltd. — Green X 12 SE (PHT-40CHS) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k521d agoShenzhen Dazhou Medical Technology Co., Ltd. — Synthetic Bone Graft Particulate (510k cleared)Guangzhou Dazhou Biomedical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k521d agoInstitut Straumann AG — Custom Abutments (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k521d agoAikenist Technologies Pvt, Ltd. — QuickRad (510k cleared)Pandorum Technologies Pvt Ltd

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k521d agoMedicom Asia-Pacific Holdings Ltd. Taiwan Branch. — Medicom Sterilization Pouch and Reel (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k521d agoShenzhen Urion Technology Co., Ltd. — Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including U80Y, U81Y, U82Y,U83Y,U86Y U80N, U81NH), U86E series (including U82E, U80E, U80EH, U81E, U83E, U85E, U80L, U87E ), U81X series (including U81X, U80X, U82X, U83X, U81D, U82D, U83D, U81RH, U82RH) and U83Z series (including U83Z, U80Z, U81Z, U82Z, U85Z, U86Z and U87Z)) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k521d agoVita Zahnfabrik H.Rauter GmbH & Co. — VITA YZ Multi Translucent (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k521d agoRti Surgical, Inc. — Moldable Bone Void Filler and Moldable Bone Void Filler + CCC (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k521d agoCepheid — Xpert® FII & FV (510k cleared)

    Product code: NPR. Advisory committee: Hematology. Type: Special

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k521d agoMaterialise NV — Materialise Personalized Guides and Models for Craniomaxillofacial Surgery (510k cleared)MATERIALISE NV

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k521d agoShenzhen TPH Technology Co., Ltd. — Wearable breast pump (model W8) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

    Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Abbreviated

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k521d agoShanghai Jianzhong Medical Packaging Co., Ltd. — Sterilization Pouches and Reels (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k521d agoProprio, Inc. — Paradigm System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k521d agoSonio — Sonio Suspect (510k cleared)

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

    full page →fda device 510k ↗

    Week of Feb 24, 2025

    32
    ›Feb 24, 2025device 510k518d 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 510k
    ← prev
    page 27 of 100
    next →
    518d ago
    Lingshi 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 510k518d 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 510k518d 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 510k518d 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 510k518d 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 510k518d agoOncosoft. Co., Ltd. — OncoStudio (OS-01) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 24, 2025device 510k518d agoUlthera, Inc. — Ulthera® System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 25, 2025device 510k517d agoGE Medical Systems SCS — 3DXR (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 25, 2025device 510k517d 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 510k517d agoFitbit — Loss of Pulse Detection (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 25, 2025device 510k517d 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 510k517d 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 510k517d 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 510k517d 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 510k517d agoJLK, Inc. — JLK-AILink (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 25, 2025device 510k517d agoPrismatik Dentalcraft, Inc. — BruxZir® Esthetic NOW (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 26, 2025device 510k516d 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 510k516d agoInquis Medical — Aventus Thrombectomy System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 26, 2025device 510k516d 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 510k516d 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 510k516d 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 510k516d 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 510k516d agoVygon Corporation — pilot TLS (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 26, 2025device 510k516d 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 510k516d agoElute, Inc. — BonVie+ (510k cleared)ELUTIA INC.

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

    full page →fda device 510k ↗
    ›Feb 26, 2025device 510k516d 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 510k516d agoFovia, Inc. — aiCockpit AI Viewer (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 26, 2025device 510k516d 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 510k515d agoNanofiber Solutions, LLC — Rotium (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 27, 2025device 510k515d 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 510k515d 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 ↗
    $FRTRY
    $CHD97.64+1.51%
    $MTLS6.5600-1.06%
    $FRTRY
    $XOSWW
    $ELUT
    $TNDM17.12+1.30%
    $KMTS20.35+8.13%