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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 Oct 28, 2024

    50
    ›Oct 29, 2024device 510k633d agoDevicor Medical Products, Inc. — Mammotome AutoCore™ Single Insertion Core Biopsy System (510k cleared)UTAH MEDICAL PRODUCTS INC

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

    full page →fda device 510k ↗
    ›Oct 29, 2024device 510k633d agoAtriCure, Inc. — AtriCure cryoICE BOX (ACM) (510k cleared)AtriCure, Inc.

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

    full page →fda device 510k ↗
    ›Oct 29, 2024device 510k633d agoRiverpoint Medical — OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft Anchor (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 29, 2024device 510k633d agoQIAGEN GmbH — QIAstat-Dx Meningitis/Encephalitis (ME) Panel (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 29, 2024device 510k633d agoTigon Medical — Tigon Medical Fractures, Instability, and Reconstruction (FIRE) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 29, 2024device 510k633d agoZimmer, Inc. — Persona the Personalized Knee System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 29, 2024device 510k633d agoVarian Medical Systems — Catheter Surface Flap Applicator Set (GM11011830) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 29, 2024device 510k633d agoJiaxing Xiaoxiang Medical Equipment Technology Co., Ltd. — Electric Wheelchair (ME23-EW16-BC200-01); Electric Wheelchair (ME23-EW16-BC200-02) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 29, 2024device 510k633d agoNovatech SA — TRACHEOBRONXANE™ DUMON® (510k cleared)Novatech SA

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

    full page →fda device 510k ↗
    ›Oct 29, 2024device 510k633d agoDegen Medical — DeGen Medical Patient Specific Implant (PSI) System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 30, 2024device 510k632d agoNeuraxis — NeurAxis IB-Stim (01-1020) (510k cleared)Neuraxis, INC

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

    full page →fda device 510k ↗
    ›Oct 30, 2024device 510k632d agoIde Vision, Ltd. — MedicCO2LON (MedicCO2LON) (510k cleared)Rail Vision Ltd.

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

    full page →fda device 510k ↗
    ›Oct 30, 2024device 510k632d agoiRhythm Technologies, Inc. — Zio AT® device (A100A1001) (510k cleared)TTM TECHNOLOGIES INC

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

    full page →fda device 510k ↗
    ›Oct 30, 2024device 510k632d agoRemedy Logic, Inc. — RemedyLogic AI MRI Lumbar Spine Reader (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 30, 2024device 510k632d agoSonomotion, Inc. — Stone Clear (SC-LP9-01) (510k cleared)

    Product code: QNA. Advisory committee: Gastroenterology, Urology. Type: Direct

    full page →fda device 510k ↗
    ›Oct 30, 2024device 510k632d agoSiemens Medical Solutions USA, Inc. — Symbia Pro.specta Q3 (11364751); Symbia Pro.specta X3 (11364752); Symbia Pro.specta X7 (11364753); Symbia Pro.specta VA30A Family (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 30, 2024device 510k632d agoMicrogenics Corporation — DRI Ecstasy Plus Assay (510k cleared)

    Product code: DKZ. Advisory committee: Clinical Toxicology. Type: Special

    full page →fda device 510k ↗
    ›Oct 30, 2024device 510k632d agoGuangdong Genial Technology Co., Ltd. — Wearable Digital Thermometer (T31) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 30, 2024device 510k632d agoSmith & Nephew, Inc. — JOURNEY II Unicompartmental Knee System (JOURNEY II UK) (510k cleared)SMITH & NEPHEW PLC

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

    full page →fda device 510k ↗
    ›Oct 30, 2024device 510k632d agoIzenimplant Co., Ltd. — ZENEX Implant System_Long (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 30, 2024device 510k632d agoHistoSonics, Inc. — Edison System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 30, 2024device 510k632d agoNingbo Medsun Medical Co., Ltd. — Safety Lancet (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 30, 2024device 510k632d agoTaiwan Main Orthopaedic Biotechnology Co., Ltd. — Caduceus S (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 30, 2024device 510k632d agoLagis Enterprise Co., Ltd. — LAGIS Endoscopic Instruments - Grasper (DI-5670-33D, DI-5670-45D, DI-5716-33D, DI-5716-45D, DI-5719-33D, DI-5731-33D, DI-5731-45D, DI-5901-33D, DI-5901-45D) (510k cleared)Cre8 Enterprise Ltd

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

    full page →fda device 510k ↗
    ›Oct 31, 2024device 510k631d agoShenzhen Mindray Bio-Medical Electronics Co., Ltd. — V80 Anesthetic Vaporizer (V80) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 31, 2024device 510k631d agoBard Access Systems, Inc. — PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable Ports (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 31, 2024device 510k631d agoBecton, Dickinson and Company — BD Vacutainer® Citrate Blood Collection Tubes (510k cleared)BECTON DICKINSON & CO

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

    full page →fda device 510k ↗
    ›Oct 31, 2024device 510k631d agoSmartcardia SA — SmartCardia 7L Platform (MCT) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 31, 2024device 510k631d agoBonebridge AG — Bonebridge Osteosynthesis Plating System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 31, 2024device 510k631d agoHighness Co., Ltd. — Highness Implant System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 31, 2024device 510k631d agoShenzhen Medke Technology Co., Ltd. — Disposable Blood Pressure cuff; Reusable Blood Pressure cuff (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Oct 31, 2024device 510k631d agoErad, Inc. — eRAD PACS (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 31, 2024device 510k631d agoBionova Medical, Inc. — Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo (510k cleared)

    Product code: FRO. Advisory committee: Unknown. Type: Special

    full page →fda device 510k ↗
    ›Nov 1, 2024device 510k630d agoWright Medical Technology, Inc. (Stryker) — Prophecy Surgical Planning System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 1, 2024device 510k630d agoMedtronic, Inc. — Affera Integrated Mapping System; Impedance Localization Patch Kit (510k cleared)Medtronic plc

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

    full page →fda device 510k ↗
    ›Nov 1, 2024device 510k630d agoShanghai United Imaging Healthcare Co., Ltd. — uDR 780i (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 1, 2024device 510k630d agoBecton, Dickinson and Company — BD Vacutainer® One Use Holder (510k cleared)BECTON DICKINSON & CO

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

    full page →fda device 510k ↗
    ›Nov 1, 2024device 510k630d agoQuanta Dialysis Technologies, Ltd. — SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 1, 2024device 510k630d agoCovidien (Part of Medtronic) — Signia™ Circular Adapter (Standard Length) (SIGCIRSTND); Signia™ Circular Adapter XL Length (SIGCIRXL) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 1, 2024device 510k630d agoFujifilm Corporation — Over-tube (TR-1108A) (510k cleared)Fujifilm Holdings Corp

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

    full page →fda device 510k ↗
    ›Nov 1, 2024device 510k630d agoGM Dos Reis Industria e Comercio Ltda. — EXPERT - Flexible Joint Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 1, 2024device 510k630d agoDRTECH Corporation — XERO-alpha (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 1, 2024device 510k630d agoPollogen, Ltd. — Legend X Desktop System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 1, 2024device 510k630d agoDepuy Orthopedics, Inc. — DePuy ATTUNE™ Total Knee System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 1, 2024device 510k630d agoBaylis Medical Company — VersaCross™ RF Wire (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 1, 2024device 510k630d ago4Web Medical, Inc. — Osteotomy Truss System (OTS) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 1, 2024device 510k630d agoAcuity Polymers, Inc. — Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 1, 2024device 510k630d agoApplied Medical Technology, Inc. — AMT Low-Profile Suprapubic Catheter & Drainage Set (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 1, 2024device 510k630d agoSkeletal Dynamics, Inc. — Total Wrist Arthroplasty System (TWA) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 1, 2024device 510k630d agoShenzhen Breo Technology Co., Ltd. — Breo Laser Hair Growth Comb (Scalp 3L) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
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    $UTMD69.19+0.06%
    $RVSN4.4000-4.56%
    $TTMI
    $BDX152.97-0.12%
    $NRXS
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    $CRE
    $SNN30.25+5.29%
    $FRTRY
    $MDT82.01+0.15%
    $BDX152.97-0.12%
    $FRTRY