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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 Jan 6, 2025

    17
    ›Jan 10, 2025device 510k562d agoTools For Surgery, LLC — ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN™ SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN™ SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN™ GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN™ GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN™ GBT Orogastric Tube - 40 Fr (ZZ-GBT-40) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 10, 2025device 510k562d agoCepheid — Xpert Xpress CoV-2/Flu/RSV plus (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 10, 2025device 510k562d agoShenzhen Ulike Smart Electronics Co., Ltd. — Ulike Reglow Light Therapy Device (UM10) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 10, 2025device 510k562d agoShenzhen Ruiankang Technology Co., Ltd. — Blood Pressure Monitor (RAK260, RAK262, RAK263, RAK266, RAK268, RAK269, RAK282, RAK283, RAK286, RAK288, RAK289, RAK291, RAK292, RAK293, RAK295, RAK296, RAK297, RAK298) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 10, 2025device 510k562d agoOverfibers S.R.L. — OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 10, 2025device 510k562d agoErchonia Corporation — Erchonia Zerona® VZ8 (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 10, 2025device 510k562d agoPromisemed Hangzhou Meditech Co., Ltd. — Safety Winged Blood Collection Sets (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 10, 2025device 510k562d agoApplied BioCode, Inc. — BioCode Gastrointestinal Pathogen Panel (GPP) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 10, 2025device 510k562d agoSafecare Biotech (Hangzhou) Co., Ltd. — Safecare Urinary Tract Infection Test (510k cleared)Hangzhou DAC Biotech Co Ltd

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

    full page →fda device 510k ↗
    ›Jan 10, 2025device 510k562d agoGlobus Medical, Inc. — NuVasive Pulse System (510k cleared)GLOBUS MEDICAL INC

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

    full page →fda device 510k ↗
    ›Jan 10, 2025device 510k562d agoKlaxon Mobility GmbH — Klaxon (Twist); Klaxon (Twist R) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 10, 2025device 510k562d agoTriopsy Medical, Inc. — Triopsy Actuator (TMSDGB); Triopsy Biopsy Needle (BN-1825-36-01); Triopsy Biopsy Needle (BN-1825-55-01) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 10, 2025device 510k562d agoInflammatix, Inc. — TriVerity (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 10, 2025device 510k562d agoPerigen, Inc. — PeriCALM Patterns 3.0 (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 10, 2025device 510k562d agoVarian Medical Systems, Inc. — Mould Probe MR Safe (510k cleared)MERIT MEDICAL SYSTEMS INC

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

    full page →fda device 510k ↗
    ›Jan 11, 2025device 510k561d agoShenzhen Yattll Industry Co., Ltd. — Electric Wheelchair (YE200) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 12, 2025device 510k560d agoMentor Worldwide, LLC — Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue Expander (510k cleared)

    Product code: LCJ. Advisory committee: Unknown. Type: Special

    full page →fda device 510k ↗

    Week of Jan 13, 2025

    33
    ›Jan 13, 2025device 510k559d 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 510k
    ← prev
    page 20 of 100
    next →
    559d ago
    Breas Medical AB — Vivo 45 LS (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 13, 2025device 510k559d 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 510k559d 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 510k559d 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 510k559d 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 510k559d agoArthrex, Inc. — Arthrex Intramedullary Nails (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 13, 2025device 510k559d 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 510k559d 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 510k559d 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 510k559d 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 510k559d 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 510k559d 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 510k559d 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 510k559d 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 510k559d 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 510k558d 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 510k558d 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 510k558d agoZest Anchors, LLC — LOCATOR Angled Abutment (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 14, 2025device 510k558d 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 510k558d agoClariance — Elegance® Anterior Cervical plate (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 14, 2025device 510k558d 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 510k558d 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 510k558d 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 510k558d 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 510k558d 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 510k558d agoImperative Care, Inc. — Zoom System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 14, 2025device 510k558d 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 510k557d 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 510k557d 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 510k557d ago3-D Matrix Europe SAS — PuraStat (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 15, 2025device 510k557d 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 510k557d 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 ↗
    $MMSI74.32+1.66%
    $GMED79.93+1.27%
    $KNOS
    $TATT
    $MDCE0.00020.00%
    $ATRC
    $PMI0.1821-4.66%
    $ZJYL