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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 Feb 10, 2025

    50
    ›Feb 10, 2025device 510k531d agoThermo 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 510k531d agoGrindguard, Inc. — Remi Custom Night Guard (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 10, 2025device 510k531d 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 510k531d 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 510k531d agoAbbott Ireland — Calcium2 (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 10, 2025device 510k531d 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 510k531d 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 510k531d 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 510k531d 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 510k530d 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 510k530d 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 510k530d 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 510k530d 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 510k530d 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 510k530d 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 510k530d agoSignus Medizintechnik GmbH — CYLOX® ST (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 11, 2025device 510k530d 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 510k530d 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 510k530d 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 510k530d agoMorari, Inc. — MOR (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 11, 2025device 510k530d 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 510k530d 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 510k529d 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 510k529d agoAspen Imaging Healthcare, Inc. — AspenView (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 12, 2025device 510k529d 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 510k529d agoOpsens, Inc. — OptoMonitor 3 (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 12, 2025device 510k529d 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 510k529d 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 510k529d 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 510k529d agoSubtle Medical, Inc. — SubtleHD (1.x) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 12, 2025device 510k529d agoQuality Electrodynamics, LLC — SureWave Elastography (Q7000225) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 12, 2025device 510k529d 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 510k529d 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 510k529d 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 510k528d 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 510k528d 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 510k528d 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 510k528d 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 ↗
    ›Feb 13, 2025device 510k528d agoPenumbra, Inc. — Penumbra System (Reperfusion Catheter RED 72) (510k cleared)Penumbra Inc

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

    full page →fda device 510k ↗
    ›Feb 13, 2025device 510k528d agoHologic, Inc. — Aptima SARS-CoV-2 Assay (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 13, 2025device 510k528d agoBoston Aesthetics, Inc. — Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 13, 2025device 510k528d agoJmt Co., Ltd. — EDEN ControlCath (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 13, 2025device 510k528d agoNeuromodulatory Devices & Applications — Ampa One System (AMPA-001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 13, 2025device 510k528d agoDenjoy Dental Co., Ltd. — Integrated Endo System (Meet Endo-II) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 13, 2025device 510k528d agoFitbit, LLC — Body Temperature Software (BTS) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 14, 2025device 510k527d agoAbbott Molecular, Inc. — Alinity m Resp-4-Plex (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 14, 2025device 510k527d agoCoreline Soft Co., Ltd. — AVIEW CAC (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 14, 2025device 510k527d agoShenzhen Kaiyan Medical Equipment Co., Ltd. — CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 14, 2025device 510k527d agoLimFlow, Inc. — LimFlow V-Ceiver (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 14, 2025device 510k527d agoAidoc Medical , Ltd. — BriefCase-Triage (510k cleared)

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

    full page →fda device 510k ↗
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