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5,000 catalysts · 18,987 approval · 5,000 device 510k · 4,779 phase readout · 4,728 grant · 2,387 8k filing · 2,000 device pma

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type: device 510k×clear all
type
  • approval18,987
  • device 510k5,000
  • phase readout4,779
  • grant4,728
  • 8k filing2,387
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • earnings295
  • therapy area

    no tagged catalysts yet

    Week of Nov 11, 2024

    19
    ›Nov 15, 2024device 510k616d agoDent4you AG — Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k616d agoCarlsmed, Inc. — aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM (510k cleared)CARLSMED, INC.

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k616d agoVuno, Inc. — VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k616d agoKoios Medical, Inc. — Koios DS (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k616d agoVascutek, Ltd. — Gelsoft™ Plus Vascular Prostheses (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k616d agoTianjin Huahong Technology Co., Ltd. — Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); Lancing device (HH-X-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T, HH-XXVII-T) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k616d agoMycardium AI Limited — 1CMR Pro (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k616d agoCreagh Medical Ltd. Dba Surmodics, Inc. — 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k616d agoUltromics Limited — EchoGo Amyloidosis (1.0) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k616d agoPhilips Ultrasound, LLC — The 5000 Compact Series Ultrasound Systems (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k616d agoVieworks Co., Ltd. — VIVIX-S 1751S (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k616d agoBlue Belt Technologies, Inc. — CORIOGRAPH Pre-Op Planning and Modeling Services (510k cleared)BETA Technologies, Inc.

    Advisory committee: Unknown. Type: Traditional

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k616d agoShenzhen Vitavitro Biotech Co., Ltd. — VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G) (510k cleared)Shenzhen MagicRNA Biotech Co Ltd

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k616d agoInfinitum Eta, Ltd. — NUVENTUS NV.C™ Dental Implant System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k616d agoB-One Ortho, Corp. — b-ONE® Total Hip System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k616d agoTHINK Surgical, Inc. — TMINI Miniature Robotic System (510k cleared)

    Product code: OLO. Advisory committee: Neurology. Type: Special

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k616d agoSurgical Instrument Service and Savings Inc.(Dba Medline Ren — Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID Technology (BD710DF282CT, BD710DF282RTS, BD710FJ282RTS, BD710FJ282CT) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k616d agoSiemens Medical Solutions USA, Inc. — ACUSON Redwood Diagnostic Ultrasound System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k616d agoLivsmed, Inc. — ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel Sealing System-ArtiSeal Generator (510k cleared)

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

    full page →fda device 510k ↗

    Week of Nov 18, 2024

    31
    ›Nov 18, 2024device 510k613d agoMindset Medical, Inc. — Informed Vital Core Application (IVC App) (510k cleared)Outset Medical, Inc.

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

    full page →fda device 510k ↗
    ›Nov 18, 2024device 510k
    ← prev
    page 10 of 100
    next →
    613d ago
    Sorin Group Italia S.R.L. — MICRO Arterial Filters (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 18, 2024device 510k613d agoZhejiang Innuovo Rehabilitation Devices Co.,Ltd — Power Wheelchair (W5538) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 18, 2024device 510k613d agoOrthocon, Inc. — Montage-XT Settable Bone Putty (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 18, 2024device 510k613d agoZhejiang Zhonglei Medical Technology Co. , Ltd. — Power wheelchair (510k cleared)Zhejiang Xinkanghe Biomedical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Nov 18, 2024device 510k613d agoTrice Medical, Inc. — Tenex 2nd Generation System (510k cleared)Tenon Medical, Inc.

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

    full page →fda device 510k ↗
    ›Nov 18, 2024device 510k613d agoDeepHealth, Inc. — Saige-Dx (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 18, 2024device 510k613d agoXiamen Weiyou Intelligent Technology Co., Ltd. — Air Pressure Therapy System (VU-IPC04B) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 18, 2024device 510k613d agoHebei Keylaser Sci-Tech Co.,Ltd — Diode laser Treatment System (K18) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 18, 2024device 510k613d agoEnlight Medical Technologies (Shenzhen) Co., Ltd. — Synxess Neurovascular Guidewire (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 18, 2024device 510k613d agoIntuitive Surgical, Inc. — da Vinci SP Instruments (SP1098) (510k cleared)INTUITIVE SURGICAL INC

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

    full page →fda device 510k ↗
    ›Nov 18, 2024device 510k613d agoPhilips Healthcare (Suzhou) Co., Ltd. — CT Collaboration Live (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 19, 2024device 510k612d agoCerrozone, LLC — CerroZone Mini (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 19, 2024device 510k612d agoNova Biomedical Corporation — Nova Allegro UACR Assay, Nova Allegro Analyzer (510k cleared)

    Product code: CGX. Advisory committee: Clinical Chemistry. Type: Dual Track

    full page →fda device 510k ↗
    ›Nov 19, 2024device 510k612d agoMaxx Orthopedics, Inc. — Freedom® Medial Congruent Liner (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 19, 2024device 510k612d agoPolarean, Inc. — XENOVIEW 3.0T Chest Coil (510k cleared)Polaris Inc.

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

    full page →fda device 510k ↗
    ›Nov 19, 2024device 510k612d agoRiverpoint Medical — Iconix Knotless Anchor (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 19, 2024device 510k612d agoDongguanshi Yiyingmei Technology Co., Ltd. — Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 19, 2024device 510k612d agoEieling Technology (Shenzhen) Limited — Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 19, 2024device 510k612d agoBraxx Biotech Co., Ltd. — “BRAXX” Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 19, 2024device 510k612d agoTaidoc Technology Corporation — XPER Technology PREMIUM Pro Blood Glucose Monitoring System (510k cleared)

    Product code: PZI. Advisory committee: Clinical Chemistry. Type: Dual Track

    full page →fda device 510k ↗
    ›Nov 19, 2024device 510k612d agoRhein Laser Technologies Co., Ltd. — Medical Thulium Fiber Laser Systems (UroFiber 60Q) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 19, 2024device 510k612d agoMiRus, LLC — EUROPA™ Posterior Cervical Fusion System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 19, 2024device 510k612d agoNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) — Natus BrainWatch System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 19, 2024device 510k612d agoSiemens Medical Solutions USA, Inc. — ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 20, 2024device 510k611d agoSmith & Nephew, Inc. — AETOS Shoulder System Stemless Humeral Prosthesis (510k cleared)SMITH & NEPHEW PLC

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

    full page →fda device 510k ↗
    ›Nov 20, 2024device 510k611d agoEterbio, Inc. — ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test (510k cleared)NutriBand Inc.

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

    full page →fda device 510k ↗
    ›Nov 20, 2024device 510k611d agoOsartis GmbH — Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 20, 2024device 510k611d agoSol-Millennium Medical, Inc. — SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle, SOL-M Luer Lock Syringe (Low Dead Space) w/Exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/Exchangeable Needle (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 20, 2024device 510k611d agoPenumbra, Inc. — Element Vascular Access System (510k cleared)Penumbra Inc

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

    full page →fda device 510k ↗
    ›Nov 20, 2024device 510k611d agoZhejiang Nysin Medical Co., Ltd. — Powered Wheelchair (NXN20-208, NXN20-211) (510k cleared)Zhejiang Medicine Co Ltd

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

    full page →fda device 510k ↗
    $OM4.5200-1.09%
    $BETA16.10+2.09%
    $CARL
    $TNON0.2832-3.11%
    $NTRB2.9000-11.59%
    $ISRG332.02-2.54%
    $SNN30.25+5.29%
    $PII72.55-2.21%
    $PEN324.29-0.11%