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4,071 catalysts · 4,728 grant · 4,071 device 510k · 3,114 approval · 3,045 8k filing · 2,000 device pma · 2,000 device recall

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2026-08-10: 0 catalysts2026-08-11: 16 catalysts2026-08-12: 19 catalysts2026-08-13: 19 catalysts2026-08-14: 4 catalysts2026-08-15: 0 catalysts2026-08-16: 0 catalysts2026-08-17: 1 catalyst2026-08-18: 2 catalysts2026-08-19: 2 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: 20 catalysts2026-10-30: 4 catalysts2026-10-31: 0 catalysts2026-11-01: 0 catalysts2026-11-02: 8 catalysts2026-11-03: 17 catalysts2026-11-04: 22 catalysts2026-11-05: 36 catalysts2026-11-06: 2 catalysts2026-11-07: 0 catalysts2026-11-08: 0 catalysts
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type: device 510k×from 2025-01-08×clear all
type
  • grant4,728
  • device 510k4,071
  • approval3,114
  • 8k filing3,045
  • device pma2,000
  • device recall2,000
device adverse event
1,000
  • recall973
  • earnings578
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Jan 6, 2025

    38
    ›Jan 8, 2025device 510k580d agoAce Medical Industry Co., Ltd. — ACE Cannula (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 8, 2025device 510k580d agoQIAGEN GmbH — QIAstat-Dx GI Panel 2 Mini B&V (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 8, 2025device 510k580d agoCeragem Co., Ltd. — Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 8, 2025device 510k580d agoW'U'S Tech Co., Ltd. — Electrical Scooter, WT-T4SU (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 8, 2025device 510k580d agoTri Dental Implants Int. AG — TRI-matrix® X-Force Implants (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 8, 2025device 510k580d agoSibel Health, Inc. — ANNE View, Central Hub (510k cleared)Seed Health Inc

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

    full page →fda device 510k ↗
    ›Jan 8, 2025device 510k580d agoInter-Med, Inc. — ReminGel (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 8, 2025device 510k580d agoLife Technologies Corporation — Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 8, 2025device 510k580d agoDormotech Medical, Ltd. — DormoTech NLab (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 8, 2025device 510k580d agoHiossen, Inc. — HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 8, 2025device 510k580d agoHartalega NGC Sdn. Bhd. — Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) (510k cleared)Teva Pharmaceuticals USA Inc

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

    full page →fda device 510k ↗
    ›Jan 8, 2025device 510k580d agoGimbo Medical Technology Shenzhen Co., Ltd. — Sperm Freezing Medium (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Jan 9, 2025device 510k579d agoPaige.Ai, Inc. — FullFocus (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 9, 2025device 510k579d agoChangzhou Finno Medical Technology Co., Ltd. — Dental Cone-beam Computed Tomography (FinScan F350) (510k cleared)Guangzhou Dazhou Biomedical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Jan 10, 2025device 510k578d agoCarl Zeiss Meditec, AG — INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 10, 2025device 510k578d agoArthrex, Inc. — Arthrex SS VAL and VAL KreuLock™ Compression Screw System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 10, 2025device 510k578d agoAskorn Medical — Universal Tendon Spacer (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 10, 2025device 510k578d agoSolo Pace, Inc. — Solo Pace Control (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 10, 2025device 510k578d agoImvaria, Inc. — ScreenDx (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 10, 2025device 510k578d agoShandong Intco Hygiene Products Co., Ltd. — Unscented Tampon (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 10, 2025device 510k578d agoBowhead Design Corp. — Bowhead ERA Wheelchairs (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 10, 2025device 510k578d 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 510k578d 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 510k578d 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 510k578d 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 510k578d 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 510k578d 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 510k578d 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 510k578d 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 510k578d 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 510k578d 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 510k578d 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 510k578d 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 510k578d agoInflammatix, Inc. — TriVerity (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 10, 2025device 510k578d 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 510k578d 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 510k577d 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 510k576d 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

    12
    ›Jan 13, 2025device 510k575d 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 1 of 82
    next →
    575d 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 510k575d 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 510k575d 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 510k575d 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 510k575d 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 510k575d agoArthrex, Inc. — Arthrex Intramedullary Nails (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 13, 2025device 510k575d 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 510k575d 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 510k575d 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 510k575d 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 510k575d 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 ↗
    $GMED79.93+1.27%
    $MMSI89.75+0.80%