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3,812 catalysts · 4,728 grant · 3,812 device 510k · 3,350 8k filing · 3,040 approval · 2,000 device pma · 2,000 device recall

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2026-08-10: 0 catalysts2026-08-11: 0 catalysts2026-08-12: 0 catalysts2026-08-13: 0 catalysts2026-08-14: 0 catalysts2026-08-15: 0 catalysts2026-08-16: 0 catalysts2026-08-17: 1 catalyst2026-08-18: 2 catalysts2026-08-19: 3 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: 21 catalysts2026-10-30: 4 catalysts2026-10-31: 0 catalysts2026-11-01: 0 catalysts2026-11-02: 9 catalysts2026-11-03: 18 catalysts2026-11-04: 22 catalysts2026-11-05: 37 catalysts2026-11-06: 2 catalysts2026-11-07: 0 catalysts2026-11-08: 0 catalysts
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type: device 510k×from 2025-02-07×clear all
type
  • grant4,728
  • device 510k3,812
  • 8k filing3,350
  • approval3,040
  • device pma2,000
  • device recall2,000
device adverse event
1,000
  • recall926
  • earnings584
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Feb 3, 2025

    11
    ›Feb 7, 2025device 510k555d agoMediclus Co., Ltd. — Any-Com Bulk (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 7, 2025device 510k555d agoLaseroptek Co., Ltd. — HELIOS 785 Pico (1754V2) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 7, 2025device 510k555d agoVarian Medical Systems, Inc. — Identify (4.0) (510k cleared)MERIT MEDICAL SYSTEMS INC

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

    full page →fda device 510k ↗
    ›Feb 7, 2025device 510k555d agoEncore Medical L.P. — ceramys™ femoral head system (510k cleared)Encore Medical, Inc.

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

    full page →fda device 510k ↗
    ›Feb 7, 2025device 510k555d agoGuangzhou Red Pine Medical Instrument Co., Ltd. — Endoscopic Video Image Processor (RP-IPD-V1000F) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 7, 2025device 510k555d agoGenesys Spine — Genesys Spine AIS-C II Cervical Interbody Fusion System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 7, 2025device 510k555d agoMedical Microinstruments, Inc. — Symani Surgical System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 7, 2025device 510k555d agoBdc Dental Corporation , Ltd. — BDC Dental Unit (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 7, 2025device 510k555d agoHetaida Technology Co., Ltd. — Electronic Blood Pressure Monitor (510k cleared)Viomi Technology Co., Ltd

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

    full page →fda device 510k ↗
    ›Feb 7, 2025device 510k555d agoAssure Tech., LLC — AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup (510k cleared)

    Product code: NFT. Advisory committee: Clinical Toxicology. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 7, 2025device 510k555d agoRoche Diagnostics — Elecsys sFlt-1 and Elecsys PlGF (510k cleared)

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

    full page →fda device 510k ↗

    Week of Feb 10, 2025

    39
    ›Feb 10, 2025device 510k552d agoThermo Fisher Scientific — The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with penicillin in the dilution range of 0.015-32 ug/mL (510k cleared)THERMO FISHER SCIENTIFIC INC.

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

    full page →fda device 510k ↗
    ›Feb 10, 2025device 510k
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    page 1 of 77
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    552d ago
    Thermo Fisher Scientific — The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.12-32 ug/mL (510k cleared)THERMO FISHER SCIENTIFIC INC.

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

    full page →fda device 510k ↗
    ›Feb 10, 2025device 510k552d agoGrindguard, Inc. — Remi Custom Night Guard (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 10, 2025device 510k552d agoHebei Ruihe Medical Devices Co., Ltd. — Locking Plates and Screws Systems (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 10, 2025device 510k552d agoPhilips Consumer Lifestyle B.V. — Philips Lumea IPL (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 10, 2025device 510k552d agoAbbott Ireland — Calcium2 (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 10, 2025device 510k552d agoChangsha Anxiang Medical Technology Co., Ltd. — OTC TENS & EMS Unit (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 10, 2025device 510k552d agoBTL Industries, Inc. — BTL-398 (510k cleared)NL INDUSTRIES INC

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

    full page →fda device 510k ↗
    ›Feb 10, 2025device 510k552d agoRaja Trading Company, Inc. — Myolight Microcurrent Handpiece (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 10, 2025device 510k552d agoPhilips Ultrasound, LLC — Ultrasound Workspace (UWS 6.0) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 11, 2025device 510k551d agoGE Medical Systems Ultrasound and Primary Care Diagnostics — Vivid iq (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 11, 2025device 510k551d agoInfinitum Eta, Ltd. — NUVENTUS NV.C™ Surgical Cassette and Tray (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 11, 2025device 510k551d agoInbella Medical, Inc. — InbellaBody System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 11, 2025device 510k551d agoNoris Medical , Ltd. — LONGY Implant and LONGY-N Implant (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 11, 2025device 510k551d agoRoche Molecular Systems, Inc. — cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 11, 2025device 510k551d agoGuangdong Xinyu Electronic and Technology Co., Ltd. — Wrist Blood Pressure Monitor (XY-W01A, XY-W01B) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 11, 2025device 510k551d agoSignus Medizintechnik GmbH — CYLOX® ST (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 11, 2025device 510k551d agoTeleflex Incorporated — Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch Endotracheal Tubes (Safety Clear Pediatric) (510k cleared)TELEFLEX INC

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

    full page →fda device 510k ↗
    ›Feb 11, 2025device 510k551d agoAbbott Diagnostics Scarborough, Inc. — BinaxNOW™ COVID-19 Antigen Self Test (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 11, 2025device 510k551d agoGE Medical Systems Ultrasound and Primary Care Diagnostics — Vivid T9/Vivid T8 (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 11, 2025device 510k551d agoMorari, Inc. — MOR (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 11, 2025device 510k551d agoDongguan Zsr Biomedical Technology Company Limited — Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 11, 2025device 510k551d agoShoulder Innovations, Inc. — InSet Total Shoulder System (510k cleared)SHOULDER INNOVATIONS, INC.

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

    full page →fda device 510k ↗
    ›Feb 12, 2025device 510k550d agoKunshan Hi-Fortune Health Products Co., Ltd. — Electrically Powered Wheelchair (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 12, 2025device 510k550d agoAspen Imaging Healthcare, Inc. — AspenView (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 12, 2025device 510k550d agoKunshan Hi-Fortune Health Products Co., Ltd. — Electrically Powered Wheelchair (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 12, 2025device 510k550d agoOpsens, Inc. — OptoMonitor 3 (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 12, 2025device 510k550d agoSiemens Medical Solutions USA, Inc. — NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 12, 2025device 510k550d agoSamsung Medison Co., Ltd. — V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 12, 2025device 510k550d agoGi Bionics, LLC — Fecobionics Anorectal System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 12, 2025device 510k550d agoSubtle Medical, Inc. — SubtleHD (1.x) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 12, 2025device 510k550d agoQuality Electrodynamics, LLC — SureWave Elastography (Q7000225) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 12, 2025device 510k550d agoEtiometry, Inc. — Etiometry Platform (DAV 5.4 RAE 9.2) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 12, 2025device 510k550d agoBiokit, S.A. — ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 12, 2025device 510k550d agoZimmer, Inc. — Affixus Tibial Nailing System - 4mm screws (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 13, 2025device 510k549d agoMaxx Orthopedics, Inc. — Freedom® Total Knee System - Porous Tibial Base Plate (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 13, 2025device 510k549d agoAssure Tech., LLC — FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 13, 2025device 510k549d agoNewclip Technics — Newclip Patient-matched instrumentation non sterile PSI (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 13, 2025device 510k549d agoDentsply Sirona, Inc. — AH Plus Endodontic Sealer (510k cleared)DENTSPLY SIRONA Inc.

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

    full page →fda device 510k ↗
    $TMO447.81+1.31%
    $VIOT
    $MMSI90.76+0.29%
    $EMI
    $NL6.0500-1.14%
    $TMO447.81+1.31%
    $TFX127.00+1.63%
    $SI
    $XRAY11.59+0.09%