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4,033 catalysts · 4,728 grant · 4,033 device 510k · 3,603 8k filing · 3,110 approval · 2,000 device pma · 2,000 device recall

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type: device 510k×from 2025-01-13×clear all
type
  • grant4,728
  • device 510k4,033
  • 8k filing3,603
  • approval3,110
  • device pma2,000
  • device recall2,000
device adverse event
1,000
  • recall963
  • earnings585
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Jan 13, 2025

    50
    ›Jan 13, 2025device 510k595d agoXiamen Weiyou Intelligent Technology Co., Ltd. — Air Pressure Therapy System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 13, 2025device 510k595d agoBreas Medical AB — Vivo 45 LS (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 13, 2025device 510k595d agoOsang, LLC — QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 13, 2025device 510k595d agoKico Knee Innovation Company Pty, Ltd. — ARVIS® Shoulder (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 13, 2025device 510k595d agoHlb Co., Ltd. Healthcare — Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus (510k cleared)NVP Healthcare Co Ltd

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

    full page →fda device 510k ↗
    ›Jan 13, 2025device 510k595d agoPrivapath Diagnostics Ltd (Dba Letsgetchecked) — LetsGetChecked Impress (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 13, 2025device 510k595d agoArthrex, Inc. — Arthrex Intramedullary Nails (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 13, 2025device 510k595d agoArineta , Ltd. — SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 13, 2025device 510k595d agoMegagen Implant Co., Ltd. — MegaGen Dental Implant Abutment (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 13, 2025device 510k595d agoAlcon Laboratories, Inc. — Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism; Dailies Total1 Multifocal; Dailies Total1 Multifocal Toric (510k cleared)Alcon Laboratories Inc

    Product code: LPL. Advisory committee: Ophthalmic. Type: Special

    full page →fda device 510k ↗
    ›Jan 13, 2025device 510k595d agoOlympus Medical Systems Corporation — High Flow Insufflation Unit (UHI-4) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 13, 2025device 510k595d agoAdler Ortho S.P.A — Pantheon Proximal Femur Reconstruction (PFR) System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 13, 2025device 510k595d agoJoytech Healthcare Co. , Ltd. — Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62D0L, DBP-62D0B, DBP-61D0, DBP-61D0L, DBP-6293L, DBP-6293B, DBP-6193) (510k cleared)NVP Healthcare Co Ltd

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

    full page →fda device 510k ↗
    ›Jan 13, 2025device 510k595d agoAzac Group — AAMI Level 4 Protective; Gown (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 13, 2025device 510k595d agoKyocera Medical Technologies, Inc. — Initia Knee System (510k cleared)Medical Care Technologies Inc.

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

    full page →fda device 510k ↗
    ›Jan 13, 2025device 510k595d agoMentor Worldwide, LLC — MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 14, 2025device 510k594d agoPfm Medical, Inc. — ASEPT® Glide Peritoneal Drainage System (510k cleared)Picard Medical, Inc.

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

    full page →fda device 510k ↗
    ›Jan 14, 2025device 510k594d agoMaduro Medical, Inc. — Radical the Dude 8F Guide Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 14, 2025device 510k594d agoZest Anchors, LLC — LOCATOR Angled Abutment (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 14, 2025device 510k594d agoAlembic, LLC — APRO 70 Swift Catheter (510k cleared)Alembic Pharmaceuticals Inc

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

    full page →fda device 510k ↗
    ›Jan 14, 2025device 510k594d agoClariance — Elegance® Anterior Cervical plate (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 14, 2025device 510k594d agoShanghai United Imaging Healthcare Co., Ltd. — uCT 550 (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 14, 2025device 510k594d agoRadiometer Medicals Aps — ABL90 FLEX PLUS System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 14, 2025device 510k594d agoZiehm-Orthoscan, Inc. — Orthoscan VERSA Mini C-Arm (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 14, 2025device 510k594d agoBiobeat Technologies , Ltd. — BB-613-BPM (510k cleared)TAT TECHNOLOGIES LTD

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

    full page →fda device 510k ↗
    ›Jan 14, 2025device 510k594d agoShalby Advanced Technologies — Consensus Knee System with TiNbN (510k cleared)KRONOS ADVANCED TECHNOLOGIES INC

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

    full page →fda device 510k ↗
    ›Jan 14, 2025device 510k594d agoImperative Care, Inc. — Zoom System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 14, 2025device 510k594d agoSpecto Medical — SpectoMed (v1.0) (510k cleared)Spectral Medical Inc

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

    full page →fda device 510k ↗
    ›Jan 15, 2025device 510k593d agoCepheid® — Xpert® Xpress CoV-2 plus (XPRS-COV2-10) (510k cleared)

    Product code: QQX. Advisory committee: Microbiology. Type: Dual Track

    full page →fda device 510k ↗
    ›Jan 15, 2025device 510k593d agoAssure Tech., LLC — FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 15, 2025device 510k593d ago3-D Matrix Europe SAS — PuraStat (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 15, 2025device 510k593d agoAtriCure, Inc. — AtriClip PRO-Mini LAA Exclusion System (PROM) (510k cleared)AtriCure, Inc.

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

    full page →fda device 510k ↗
    ›Jan 15, 2025device 510k593d agoTrudell Medical International — AeroChamber2go Anti-Static Valved Holding Chamber (510k cleared)Jin Medical International Ltd.

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

    full page →fda device 510k ↗
    ›Jan 15, 2025device 510k593d agoAlcresta Therapeutics, Inc. — RELiZORB (100300/ 100301) (510k cleared)Alcyone Therapeutics Inc

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

    full page →fda device 510k ↗
    ›Jan 15, 2025device 510k593d agoTriMed, Inc. — TriMed Wrist Fixation System (Volar Bearing Plates); TriMed Wrist Fixation System (Volar Fixed Angle Plates); TriMed Wrist Fixation System (Hook Plates); TriMed Wrist Fixation System (Pin Plates); TriMed Wrist Fixation System (Peg Plates); TriMed Wrist Fixation System (Shear Plates); TriMed Wrist Fixation System (Wireform plates and Washer); TriMed Wrist Fixation System (Wireforms); TriMed Wrist Fixation System (Torx Cortical Screws); TriMed Wrist Fixation System (Torx Threaded Pegs); (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 15, 2025device 510k593d agoCaption Health, Inc. — Cardiac Guidance (510k cleared)Option Care Health, Inc.

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

    full page →fda device 510k ↗
    ›Jan 15, 2025device 510k593d agoSunray Medical Products, Inc. — Powder Free Nitrile Examination Gloves (Blue, Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (510k cleared)UTAH MEDICAL PRODUCTS INC

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

    full page →fda device 510k ↗
    ›Jan 15, 2025device 510k593d agoSynovis Micro Companies Alliance A Subsidiary of Baxter Int — GEM ZIPCLIP (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 15, 2025device 510k593d agoEffortmed, LLC — EffortMed Spinal Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 15, 2025device 510k593d agoMerit Medical Systems, Inc. — Ventrax™ Delivery System (510k cleared)MERIT MEDICAL SYSTEMS INC

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

    full page →fda device 510k ↗
    ›Jan 15, 2025device 510k593d agoSuzhou Minhua Medical Apparatus Supplies Co., Ltd. — Venera 608 Deep Vein Thrombosis (DVT) Prevention System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 15, 2025device 510k593d agoMerit Medical Systems, Inc. — Micro Ace Gold Advanced Micro Access System (510k cleared)MERIT MEDICAL SYSTEMS INC

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

    full page →fda device 510k ↗
    ›Jan 15, 2025device 510k593d agoShenzhen Deliduo Medical Technology Co.,Ltd — Electrode Pad (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 15, 2025device 510k593d agoZiehm Imaging GmbH — Ziehm Vision RFD (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 15, 2025device 510k593d agoHaemonetics Corporation — TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge (510k cleared)HAEMONETICS CORP

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

    full page →fda device 510k ↗
    ›Jan 15, 2025device 510k593d agoBMC Medical Co., Ltd. — Respiration Data Management Software (PAP Link PC) (510k cleared)MegaPro Biomedical Co Ltd

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

    full page →fda device 510k ↗
    ›Jan 16, 2025device 510k592d agoInmedix, Inc. — CloudHRV™ System (100-01-001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 16, 2025device 510k592d agoYa-Man, Ltd. — Medi Lift Mask (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 16, 2025device 510k592d agoCala Health, Inc. — Cala kIQ (510k cleared)CARDINAL HEALTH INC

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

    full page →fda device 510k ↗
    ›Jan 16, 2025device 510k592d agoWondfo USA Co, Ltd. — WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest (510k cleared)

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

    full page →fda device 510k ↗
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    $OPCH
    $ZJYL
    $MMSI90.49+1.06%
    $MDCE0.00020.00%
    $MMSI90.49+1.06%
    $KNOS
    $TATT
    $UTMD69.19+0.06%
    $PMI0.1821-4.66%
    $ATRC
    $HAE
    $CAH234.55-0.25%