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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 3, 2025

    49
    ›Feb 3, 2025device 510k538d agoAlphatec Spine — IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi Cervical Porous Ti Interbody System; IdentiTi NanoTec Cervical Interbody System; IdentiTi Cervical Standalone Interbody System; IdentiTi NanoTec Cervical Standalone Interbody System; IdentiTi ALIF Standalone Interbody System; IdentiTi NanoTec ALIF Standalone Interbody System; Transcend PEEK Interbody System; Transcend NanoTec Interbody System; Transcend Cervical PEEK Interbody System; Transcend NanoTec Cer (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 3, 2025device 510k538d agoMim Software, Inc. — Contour ProtégéAI+ (510k cleared)ASURE SOFTWARE INC

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

    full page →fda device 510k ↗
    ›Feb 3, 2025device 510k538d agoPranaq Pte. , Ltd. — TipTraQ (TTQ001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 3, 2025device 510k538d agoZavation Medical Products, LLC — Tiger 2 System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 3, 2025device 510k538d agoGuangdong Xinyu Electronic and Technology Co., Ltd. — Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 3, 2025device 510k538d agoIhealth Labs, Inc. — iCare APP (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 4, 2025device 510k537d agoLargan Medical Co., Ltd. — Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens (510k cleared)

    Product code: LPL. Advisory committee: Ophthalmic. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 4, 2025device 510k537d agoRoclub GmbH — rTOP (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 4, 2025device 510k537d agoVenclose, Inc. — Venclose digiRF Generator (VCRFG1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 4, 2025device 510k537d agoGeon Corporation — Geon (S2) Nasal Aspirator (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 5, 2025device 510k536d agoShenzhen Eyco Technology Co., Ltd. — LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Feb 5, 2025device 510k536d agoClaronav — Navient Image Guide Navigation System (955-NC-NC), Cranial (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 5, 2025device 510k536d agoTrainfes — TrainFES Advance (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 5, 2025device 510k536d agoAccurate Meditech, Inc. — Accurate Mini Non-invasive blood pressure monitor (AMB-001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 5, 2025device 510k536d agoDepuy Mitek — GRYPHON™ X Anchor; HEALIX TRANSTEND™ Anchor (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 5, 2025device 510k536d agoNvision Biomedical Technologies — Caliber Intramedullary Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 5, 2025device 510k536d agoSurGenTec, LLC — GraftGun Universal Graft Delivery System (GDS) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 5, 2025device 510k536d agoGleamer Sas — BoneMetrics (US) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 5, 2025device 510k536d agoCreo Medical, Ltd. — CROMA Electrosurgical Generator (PRD-EMR-050) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 6, 2025device 510k535d agoSTERIS Corporation — Celerity Incubator (510k cleared)STERIS plc

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

    full page →fda device 510k ↗
    ›Feb 6, 2025device 510k535d agoNovatech SA — DUTAU-NOVATECH® (510k cleared)Novatech SA

    Product code: EOQ. Advisory committee: Ear, Nose, Throat. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 6, 2025device 510k535d agoXuzhou Kernel Medical Equipment Co., Ltd. — 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 6, 2025device 510k535d agoUnimed Medical Supplies, Inc. — Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2 Sensors (U403-254); Unimed Reusable Finger Clip SpO2 Sensors (U103-254); Unimed Reusable Finger Clip SpO2 Sensors (U403-125) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 6, 2025device 510k535d agoBeijing Zksk Technology Co., Ltd. — Disposable Sphincterotome (510k cleared)Beijing Geekplus Technology Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Feb 6, 2025device 510k535d agoSTERIS Corporation — Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045) (510k cleared)STERIS plc

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

    full page →fda device 510k ↗
    ›Feb 6, 2025device 510k535d agoSignature Orthopaedic Pty , Ltd. — Signature Osteosynthesis Plate System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 6, 2025device 510k535d agoPhilips Ultrasound, LLC — EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 6, 2025device 510k535d agoGuangzhou Chuang Zao Mei Technology Co., Ltd. — Diode Laser Hair Removal Device (EVOLUTION MEDICAL); Diode Laser Hair Removal Device (M-I-X MEDICAL); Diode Laser Hair Removal Device (GENESIS); Diode Laser Hair Removal Device (Lotus); Diode Laser Hair Removal Device (Ultimate) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 6, 2025device 510k535d agoTermosalud — VMAT PRO (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 6, 2025device 510k535d agoQuantalx Neuroscience, Ltd. — Delphi MCS Electrode Cap (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 6, 2025device 510k535d agoEver Global (Vietnam) Enterprise Corporation — Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate and Xylazine (510k cleared)Teva Pharmaceuticals USA Inc

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

    full page →fda device 510k ↗
    ›Feb 6, 2025device 510k535d agoBoston Scientific Corporation — Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M00522602); Resolution Clip (M00522610); Resolution Clip (M00522611); Resolution Clip (M00522612) (510k cleared)BOSTON SCIENTIFIC CORP

    Product code: PKL. Advisory committee: Gastroenterology, Urology. Type: Special

    full page →fda device 510k ↗
    ›Feb 6, 2025device 510k535d agoHowmedica Osteonics Corp., Dba Stryker Orthopaedics — Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior Stabilized Tibial Insert; Scorpio-Flex Cruciate Retaining Tibial Insert; Scorpio NRG Tibial Bearing Insert – Cruciate Retaining Insert; Scorpio NRG Tibial Bearing Insert – Posteriorly Stabilized Insert (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 6, 2025device 510k535d agoOrthonovis, Inc. — BPS - Bone Fragment Fixation Plates, Screws and Washers (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 6, 2025device 510k535d agoGuangzhou Decheng Biotechnology Co., Ltd. — Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup Plus (510k cleared)Guangzhou Zhiyi Biotechnology Co Ltd

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

    full page →fda device 510k ↗
    ›Feb 6, 2025device 510k535d agoAsahi Intecc Co., Ltd. — CROSSLEAD 0.014inch (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 6, 2025device 510k535d agoUnimom.Co — VIVACE (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 6, 2025device 510k535d agoHowmedica Osteonics Corp., Dba Stryker Orthopaedics — Stryker Orthopaedics Hip Devices Labeling Update (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 7, 2025device 510k534d agoMediclus Co., Ltd. — Any-Com Bulk (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 7, 2025device 510k534d 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 510k534d 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 510k534d 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 510k534d 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 510k534d 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 510k534d 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 510k534d 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 510k534d 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 510k534d 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 510k534d 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

    1
    ›Feb 10, 2025device 510k531d 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 ↗
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    $FRTRY
    $STE214.07+1.63%
    $ASUR8.2700+1.35%
    $BJGPY
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    $MMSI74.32+1.66%
    $BSX44.25+1.54%
    $EMI
    $VIOT
    $TMO447.81+1.31%