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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 Dec 30, 2024

    13
    ›Jan 3, 2025device 510k568d agoInbella Medical, Inc. — Inbella RF System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 3, 2025device 510k568d agoEunsung Global Corp — DUET-V (Model: ESK-3261DV) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 3, 2025device 510k568d agoProimtech Saglik Urunleri Anonim Sirketi — GBR System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 3, 2025device 510k568d agoDk Medical System — INNOVISION-EXII (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 3, 2025device 510k568d agoSiemens Medical Solutions USA, Inc. — syngo.CT Dual Energy (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 3, 2025device 510k568d agoAbbott Point of Care, Inc. — i-STAT hs-TnI cartridge with the i-STAT 1 System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 3, 2025device 510k568d agoInventis S.R.L. — Synapsys VHIT (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 3, 2025device 510k568d agoMallinckrodt Manufacturing, LLC — EVOLVE Nitric Oxide Delivery System (510k cleared)Mallinckrodt LLC

    Product code: MRN. Advisory committee: Anesthesiology. Type: Special

    full page →fda device 510k ↗
    ›Jan 3, 2025device 510k568d agoNobel Biocare AB — NobelProcera Zirconia Implant Bridge (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 3, 2025device 510k568d agoZinkh NV — Elemental Granulate (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 3, 2025device 510k568d agoOrmco Corporation — Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree Adhesive (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 3, 2025device 510k568d agoGe Medical Systems Israel, Functional Imaging — Clarify DL (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 3, 2025device 510k568d agoJLK, Inc. — JLK-ICH (510k cleared)

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

    full page →fda device 510k ↗

    Week of Jan 6, 2025

    37
    ›Jan 6, 2025device 510k565d agoArum Dentistry Co., Ltd. — SD TL Implant System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 6, 2025device 510k
    ← prev
    page 19 of 100
    next →
    565d ago
    United Orthopedic Corporation — Conformity Stem Extension Line, #0 (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 6, 2025device 510k565d agoTHINK Surgical, Inc. — TMINI Miniature Robotic System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 6, 2025device 510k565d agoShenzhen Sontu Medical Imaging Equipment Co., Ltd. — Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E)) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 6, 2025device 510k565d agoYongkang Yile Vehicle Co., Ltd. — Mobility Scooter (YL-09B, YL-07) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 6, 2025device 510k565d agoOmega Medical Imaging, LLC — Soteria E-View (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 6, 2025device 510k565d agoBrainomix Limited — Brainomix 360 e-CTA (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 6, 2025device 510k565d agoWhill, Inc. — WHILL Model R (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 6, 2025device 510k565d agoFesariustherapeutics, Inc. — DermiSphere Dermal Template (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 7, 2025device 510k564d agoShanghai United Imaging Healthcare Co., Ltd. — uCT 780 (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 7, 2025device 510k564d agoCanon Medical Systems Corporation — Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 7, 2025device 510k564d agoDRGEM Corporation — GXR-Series Diagnostic X-Ray System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 7, 2025device 510k564d agoAstura Medical — MASADA Modular Spinal Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 7, 2025device 510k564d agoOrbusNeich Medical (Shenzhen) Co., Ltd. — COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 7, 2025device 510k564d agoTargeted Genomics, LLC — GlutenID Celiac Genetic Health Risk Test (510k cleared)Dawn Sea Therapeutics

    Product code: PTA. Advisory committee: Immunology. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 7, 2025device 510k564d agoCorin U.S.A. Limited — ApolloHipX (THR.SS.0001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 8, 2025device 510k563d 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 510k563d 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 510k563d 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 510k563d 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 510k563d 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 510k563d 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 510k563d agoInter-Med, Inc. — ReminGel (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 8, 2025device 510k563d 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 510k563d agoDormotech Medical, Ltd. — DormoTech NLab (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 8, 2025device 510k563d 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 510k563d 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 510k563d 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 510k562d agoPaige.Ai, Inc. — FullFocus (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 9, 2025device 510k562d 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 510k561d 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 510k561d 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 510k561d agoAskorn Medical — Universal Tendon Spacer (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 10, 2025device 510k561d agoSolo Pace, Inc. — Solo Pace Control (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 10, 2025device 510k561d agoImvaria, Inc. — ScreenDx (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 10, 2025device 510k561d 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 510k561d agoBowhead Design Corp. — Bowhead ERA Wheelchairs (510k cleared)

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

    full page →fda device 510k ↗