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4,461 catalysts · 4,728 grant · 4,461 device 510k · 3,605 8k filing · 3,196 approval · 2,000 device pma · 2,000 device recall

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type: device 510k×from 2024-11-25×clear all
type
  • grant4,728
  • device 510k4,461
  • 8k filing3,605
  • approval3,196
  • device pma2,000
  • device recall2,000
recall
1,093
  • device adverse event1,000
  • earnings585
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Nov 25, 2024

    50
    ›Nov 25, 2024device 510k644d agoHeroic Faith International , Ltd. — AccurSound Electronic Stethoscope (AS101) (510k cleared)TH International Ltd

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

    full page →fda device 510k ↗
    ›Nov 25, 2024device 510k644d agoSignature Orthopaedics Pty, Ltd. — World Liner (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 25, 2024device 510k644d ago3M Company — 3M™ Attest™ Super Rapid Readout Biological Indicator 1493; 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490M (510k cleared)3M CO

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

    full page →fda device 510k ↗
    ›Nov 25, 2024device 510k644d agoZhejiang Kairui Medical Device Co., Ltd. — Electric Wheelchair (KR8803) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 25, 2024device 510k644d agoDentsply Sirona, Inc. — MIS LYNX Conical Connection Implant System (510k cleared)DENTSPLY SIRONA Inc.

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

    full page →fda device 510k ↗
    ›Nov 25, 2024device 510k644d agoShandong Huamei Technology Co., Ltd. — EMS Sculpt Machine (510k cleared)Shandong Boan Biotechnology Co Ltd

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

    full page →fda device 510k ↗
    ›Nov 25, 2024device 510k644d agoScreenpoint Medical B.V. — Transpara (2.1.0) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 25, 2024device 510k644d agoHologic, Inc. — Aptima BV Assay; Aptima CV/TV Assay (510k cleared)

    Product code: PQA. Advisory committee: Microbiology. Type: Special

    full page →fda device 510k ↗
    ›Nov 25, 2024device 510k644d agoArum Dentistry Co., Ltd. — Customized Abutment (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 25, 2024device 510k644d agoEemagine Medical Imaging Solutions GmbH — WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 25, 2024device 510k644d agoFH Industrie — JARVIS Glenoid Reverse Shoulder Prosthesis (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 25, 2024device 510k644d agoKnox Medical Diagnostics — Aluna 2 (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 25, 2024device 510k644d agoLiquet Medical, Inc. — Versus™ Catheter (VS110-8B) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 26, 2024device 510k643d agoLVIS Corporation — NeuroMatch (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 26, 2024device 510k643d agoTraferox Technologies, Inc. — LungProtect (510k cleared)TETRA TECHNOLOGIES INC

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

    full page →fda device 510k ↗
    ›Nov 26, 2024device 510k643d agoCirca Scientific, Inc. — Cross Wise™ Multi-Use RF Adapter Cable (510k cleared)Clear Scientific Inc

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

    full page →fda device 510k ↗
    ›Nov 26, 2024device 510k643d agoAtlas Spine, Inc. — Atlas Spine Lateral Expandable Interbody System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 26, 2024device 510k643d agoVarian Medical Systems — Intraluminal Applicator Set (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 26, 2024device 510k643d agoDentscare Ltda — PrimmaArt (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 26, 2024device 510k643d agoRadunity Corp. — RadUnity (Version 1.0.0) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 26, 2024device 510k643d agoColoplast Corp. — SureCath Set (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 26, 2024device 510k643d agoVIOL Co., Ltd. — Cellinew (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 26, 2024device 510k643d agoSmith & Nephew Inc., Endoscopy Div. — REGENETEN™ Bioinductive Implant (510k cleared)SMITH & NEPHEW PLC

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

    full page →fda device 510k ↗
    ›Nov 26, 2024device 510k643d agoIntuitive Surgical, Inc. — da Vinci SP Surgical System (SP1098) (510k cleared)INTUITIVE SURGICAL INC

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

    full page →fda device 510k ↗
    ›Nov 26, 2024device 510k643d agoTriMed, Inc. — TriMed Posterior Malleolus Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 26, 2024device 510k643d agoTerumo Corporation — R2P Radifocus Glidewire Advantage (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 26, 2024device 510k643d agoSolco Biomedical Co., Ltd. — 4CIS® Chiron Spinal Fixation System (510k cleared)ACRO BIOMEDICAL CO., LTD.

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

    full page →fda device 510k ↗
    ›Nov 26, 2024device 510k643d agoRiverpoint Medical, LLC — OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel Construct (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 26, 2024device 510k643d agoThermo Fisher Scientific — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Daptomycin in the dilution range of 0.03-64 ug/mL (510k cleared)THERMO FISHER SCIENTIFIC INC.

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

    full page →fda device 510k ↗
    ›Nov 26, 2024device 510k643d agoSprintray, Inc. — Digital Temp (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 26, 2024device 510k643d agoShenzhen Imdk Medical Technology Co., Ltd. — Arm Blood Pressure Monitor (model: BPM-A7VL) (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Nov 26, 2024device 510k643d agoAsg Superconductors S.P.A. — MROpen Evo (03-2000-00); MROpen Evo (03-4000-00) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 26, 2024device 510k643d agoFootbridge Medical — HyperFlex™ Bunion Correction System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 27, 2024device 510k642d agoNextbiomedical Co., Ltd. — Nexpowder (510k cleared)ACRO BIOMEDICAL CO., LTD.

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

    full page →fda device 510k ↗
    ›Nov 27, 2024device 510k642d agoDeka Research & Development Corp. — Remunity System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 27, 2024device 510k642d agoEizo Corporation — RadiForce RX570; RadiForce RX570-AR (510k cleared)

    Product code: PGY. Advisory committee: Radiology. Type: Abbreviated

    full page →fda device 510k ↗
    ›Nov 27, 2024device 510k642d agoOntact Health Co., Ltd. — Sonix Health (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 27, 2024device 510k642d agoSamsung Medison Co., Ltd. — HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 27, 2024device 510k642d agoEasymed Instruments Co., Ltd. — Pelvic Floor Stimulator (Intrelief PFE) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 27, 2024device 510k642d agoShenzhen Walton Technology Co., Ltd. — LED Light Therapy Machine (G1, G3, G4, G6) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Nov 27, 2024device 510k642d agoCyden Limited — SmoothSkin Pure Switch (SSC1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 27, 2024device 510k642d agoKarl Storz SE & CO. KG — KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 27, 2024device 510k642d agoVilex, LLC — TACTIX Vector Syndesmosis System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 27, 2024device 510k642d agoCeragem Co., Ltd. — Ceragem Automatic Thermal Massager (CGM-MB-1902) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 27, 2024device 510k642d agoPrevest Denpro Limited — C&B Ceramic; C&B Permanent; C&B Interim (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 27, 2024device 510k642d agoCellmyx — AirSculpt Body Contouring System (AIRS-1-SYS) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 27, 2024device 510k642d agoSharkninja Operating, LLC — CryoGlow (FW3XXXX) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 27, 2024device 510k642d agoBard Access Systems, Inc. — PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 27, 2024device 510k642d agoSpectrum Vascular — SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 27, 2024device 510k642d agoConmed Corporation — BioBrace® (510k cleared)CONMED Corp

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

    full page →fda device 510k ↗
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    $THCH
    $TMO447.81+1.31%
    $ACBM
    $SNN28.97-0.55%
    $ACBM
    $MMM
    $TTI
    $ISRG372.60+1.51%
    $XRAY11.12+0.72%
    $FRTRY
    $CNMD32.58+1.46%