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3,734 catalysts · 4,728 grant · 3,734 device 510k · 3,603 8k filing · 3,018 approval · 2,000 device pma · 2,000 device recall

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type: device 510k×from 2025-02-19×clear all
type
  • grant4,728
  • device 510k3,734
  • 8k filing3,603
  • approval3,018
  • device pma2,000
  • device recall2,000
device adverse event
1,000
  • recall916
  • earnings585
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Feb 17, 2025

    50
    ›Feb 19, 2025device 510k558d agoInstitut Straumann AG — Straumann InLab Validated Workflow (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 19, 2025device 510k558d agoVisby Medical, Inc. — Visby Medical Respiratory Health Test (510k cleared)Vivani Medical, Inc.

    Product code: QOF. Advisory committee: Microbiology. Type: Dual Track

    full page →fda device 510k ↗
    ›Feb 19, 2025device 510k558d agoDci International, LLC — Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus (510k cleared)Arrow International LLC

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

    full page →fda device 510k ↗
    ›Feb 19, 2025device 510k558d agoAvita Corporation — AViTA Pulse Oximeter (SP62B) (510k cleared)Teva Pharmaceuticals USA Inc

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

    full page →fda device 510k ↗
    ›Feb 19, 2025device 510k558d agoSichuan Qianli-Beoka Medical Technology, Inc. — Air compression massager (ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3, ACM-PLUS-A4, ACM-PLUS-A5, ACM-PLUS-A6) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 19, 2025device 510k558d agoOptosurgical, LLC — OPTOVISION Endoscopic Light Source Unit (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 19, 2025device 510k558d agoArcuro Medical , Ltd. — SuperBall-RC™ (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 19, 2025device 510k558d agoDavol, Inc., A Subsidiary of C.R. Bard, Inc. — Phasix ST Umbilical Hernia Patch (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 19, 2025device 510k558d agoShenzhen Bsx Technology Electronics Co., Ltd. — Wrist Digital Blood Pressure Monitor (BSX312, BSX313, BSX315, BSX322, BSX323, BSX353, BSX355) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 19, 2025device 510k558d agoBrainomix Limited — Brainomix 360 e-Lung (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 19, 2025device 510k558d agoQuanta System Spa — Single Use CO2 Laser Fiber (HAF005001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 19, 2025device 510k558d agoImplant Microdent System S.L.U. — Microdent Sterilization Cassette (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 19, 2025device 510k558d agoBiomet Orthopedics — A.L.P.S. Small Fragment Plating System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 19, 2025device 510k558d agoSmith & Nephew — EVOS Pelvic and Acetabular System (510k cleared)SMITH & NEPHEW PLC

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

    full page →fda device 510k ↗
    ›Feb 20, 2025device 510k557d agoGuangzhou Decheng Biotechnology Co., Ltd. — Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro (510k cleared)Guangzhou Zhiyi Biotechnology Co Ltd

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

    full page →fda device 510k ↗
    ›Feb 20, 2025device 510k557d agoReveal Lasers , Ltd. — Medical diode laser systems (CHARISMA, REGAL) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 20, 2025device 510k557d agoSteris Corparation — Defendo Fujifilm 700 Single Use Cleaning Adapter (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 20, 2025device 510k557d agoArthrex, Inc. — Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 20, 2025device 510k557d agoCaristo Diagnostics , Ltd. — CaRi-Plaque (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 20, 2025device 510k557d agoUnimed Medical Supplies, Inc. — Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U403-91); Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U410-91) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 20, 2025device 510k557d agoIpreg Incorporation — SperSort™ Sperm Sorting Chip (IPG02) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 20, 2025device 510k557d agoEver Fortune.Ai, Co., Ltd. — EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 20, 2025device 510k557d agoOrmco Corporation — SparkTM Clear Aligner System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 20, 2025device 510k557d agoSteritec Products, Inc. (A Getinge Company) — Green Card Bowie-Dick Test (BD115) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 20, 2025device 510k557d agoNurodata, Inc. — NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner (NUSONO-L75); NUSONO Handheld Ultrasound Scanner (NUSONO-P25) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 20, 2025device 510k557d agoCardiocalm Srl — CER-S (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 20, 2025device 510k557d agoLinkBio Corp. — CORE Shoulder System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 20, 2025device 510k557d agoCompumedics Limited — Falcon HST (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 20, 2025device 510k557d agoEdan Instruments, Inc. — Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8, Acclarix AX75, Acclarix AX78, Acclarix AX8 Exp, Acclarix AX8 Super), Acclarix AX9 Series Diagnostic Ultrasound Szystem (Model: Acclarix AX9 Basic, Acclarix AX9, Acclarix AX9 Exp, Acclarix AX9 Super, Acclarix AX85, Acclarix AX88) (510k cleared)VEECO INSTRUMENTS INC

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

    full page →fda device 510k ↗
    ›Feb 20, 2025device 510k557d agoAbbott Laboratories — Alinity h-series System (510k cleared)ABBOTT LABORATORIES

    Product code: GKZ. Advisory committee: Hematology. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k556d agoOrthopediatrics Canada Ulc Dba Pega Medical — Fassier-Duval Telescoping IM System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k556d agoTaiwan Dental Materials Co., Ltd. — TEMP MASTER, PMMA-based dental resin (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k556d agoLyma Life , Ltd. — LYMA Laser PRO (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k556d agoSpinal Elements, Inc. — Primus Spinal Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k556d agoExtremity Medical, LLC — Extremity Medical External Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k556d agoScandiags AG — ScanDiags Ortho L-Spine MR-Q (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k556d agoChurch & Dwight Co., Inc. — Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy) (510k cleared)CHURCH & DWIGHT CO INC /DE/

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k556d agoIntradin (Shanghai) Machinery Co., Ltd. — Powered Mobility Scooter (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k556d agoVATECH Co., Ltd. — Green X 12 SE (PHT-40CHS) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k556d agoShenzhen Dazhou Medical Technology Co., Ltd. — Synthetic Bone Graft Particulate (510k cleared)Guangzhou Dazhou Biomedical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k556d agoInstitut Straumann AG — Custom Abutments (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k556d agoAikenist Technologies Pvt, Ltd. — QuickRad (510k cleared)Pandorum Technologies Pvt Ltd

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k556d agoMedicom Asia-Pacific Holdings Ltd. Taiwan Branch. — Medicom Sterilization Pouch and Reel (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k556d agoShenzhen Urion Technology Co., Ltd. — Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including U80Y, U81Y, U82Y,U83Y,U86Y U80N, U81NH), U86E series (including U82E, U80E, U80EH, U81E, U83E, U85E, U80L, U87E ), U81X series (including U81X, U80X, U82X, U83X, U81D, U82D, U83D, U81RH, U82RH) and U83Z series (including U83Z, U80Z, U81Z, U82Z, U85Z, U86Z and U87Z)) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k556d agoVita Zahnfabrik H.Rauter GmbH & Co. — VITA YZ Multi Translucent (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k556d agoRti Surgical, Inc. — Moldable Bone Void Filler and Moldable Bone Void Filler + CCC (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k556d agoCepheid — Xpert® FII & FV (510k cleared)

    Product code: NPR. Advisory committee: Hematology. Type: Special

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k556d agoMaterialise NV — Materialise Personalized Guides and Models for Craniomaxillofacial Surgery (510k cleared)MATERIALISE NV

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k556d agoShenzhen TPH Technology Co., Ltd. — Wearable breast pump (model W8) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k556d agoShanghai Jianzhong Medical Packaging Co., Ltd. — Sterilization Pouches and Reels (510k cleared)

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

    full page →fda device 510k ↗
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    $FRTRY
    $MTLS6.5600-1.06%
    $VANI1.6000+18.52%
    $CHD101.26-1.08%
    $FRTRY
    $ABT112.47+0.79%
    $SNN28.97-0.55%
    $VECO59.42+2.95%