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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

    4
    ›Nov 1, 2024device 510k630d agoBoston Scientific Corporation — EP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ Unidirectional Steerable Diagnostic Catheter; Dynamic XT™ Unidirectional Steerable Diagnostic Catheter (510k cleared)BOSTON SCIENTIFIC CORP

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

    full page →fda device 510k ↗
    ›Nov 1, 2024device 510k630d agoParagon 28, Inc. — Monkey Bars Pin to Bar External Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 1, 2024device 510k630d agoMvitro Co., Ltd. — ORTIV (ORTIV-BL, ORTIV-WH) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 1, 2024device 510k630d agoSpident Co., Ltd. — FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack) (510k cleared)

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

    full page →fda device 510k ↗

    Week of Nov 4, 2024

    46
    ›Nov 4, 2024device 510k627d agoBionime Corporation — RIGHTEST Blood Glucose Monitoring System Max Tel (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 4, 2024device 510k
    ← prev
    page 8 of 100
    next →
    627d ago
    JLK, Inc. — JLK-PWI (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 4, 2024device 510k627d agoLumithera, Inc. — Valeda Light Delivery System (510k cleared)

    Product code: SDE. Advisory committee: Ophthalmic. Type: Direct

    full page →fda device 510k ↗
    ›Nov 4, 2024device 510k627d agoNovoxel , Ltd. — Tixel i (TXLI0001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 4, 2024device 510k627d agoZheJiang Decans Medical Devices Co., Ltd. — Gemini Cervical Fusion Cage System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 4, 2024device 510k627d agoChangsha Anxiang Medical Technology Co., Ltd. — Muscle and Nerve Stimulator TENS & EMS (TP2208), Muscle and Nerve Stimulator TENS & EMS (TP2208C) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 4, 2024device 510k627d agoSonostik, LLC — SonoStik Guide Wire Introducer (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 4, 2024device 510k627d agoComercializadora Brever — CDB Hospital ® Sterilization Wrap (70 gsm); CDB Hospital ® Sterilization Wrap (44 gsm) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 5, 2024device 510k626d agoKyocera Medical Technologies, Inc. — Skyway Anterior Cervical Plate System (510k cleared)Medical Care Technologies Inc.

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

    full page →fda device 510k ↗
    ›Nov 5, 2024device 510k626d agoFirst Medical Source, LLC — InfuLife (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 5, 2024device 510k626d agoTerrats Medical SL — DESS Dental Smart Solutions (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 5, 2024device 510k626d agoQuantalx Neuroscience — Delphi Stimulator (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 5, 2024device 510k626d agoShenzhen Kentro Medical Electronics Co., Ltd. — Transcutaneous Electronic Nerve Stimulator (KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2491, KTR-2492, KTR-2493, KTR-2494) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 5, 2024device 510k626d agoImaxeon Pty, Ltd. — MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 5, 2024device 510k626d agoGri-Alleset, Inc. — gentleheel® Adult Incision Device (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 5, 2024device 510k626d agoOrthopedic Designs North America, Inc. (Odi-Na) — Atlas™ Humeral Nail System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 5, 2024device 510k626d agoJeisys Medical, Inc. — POTENZA (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 5, 2024device 510k626d agoCardio Flow Inc., — FreedomFlow™ Orbital Circumferential Atherectomy System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 5, 2024device 510k626d agoTerarecon,Inc. — TeraRecon Cardiac.Chambers.MR (1.0.0) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 5, 2024device 510k626d agoCarboFix Orthopedics , Ltd. — CarboClear® Hybrid Pedicle Screw System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 6, 2024device 510k625d agoNu Eyne Co., Ltd. — ELEXIR 2.0 (ALLIVE3) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 6, 2024device 510k625d agoAcuitive Technologies, Inc. — Citrepore™ (510k cleared)Aeva Technologies, Inc.

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

    full page →fda device 510k ↗
    ›Nov 6, 2024device 510k625d agoBiofire Diagnostics, LLC (Biomerieux) — BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus) (510k cleared)

    Product code: QDS. Advisory committee: Pathology. Type: Special

    full page →fda device 510k ↗
    ›Nov 6, 2024device 510k625d agoMedtech Products, Inc. — Compound W Skin Tag Remover (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 6, 2024device 510k625d agoBiotech Dental, LLC — Accelx Implant System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 6, 2024device 510k625d agoAsclepion Laser Technologies GmbH — MultiCut Solo (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 6, 2024device 510k625d agoMedisurge, LLC — Agility Symmetric™ Total Knee System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 6, 2024device 510k625d agoShenzhen Ulike Smart Electronics Co., Ltd. — Ice Cooling IPL Hair Removal Device (UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 6, 2024device 510k625d agoABBOTT MEDICAL — Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 7, 2024device 510k624d agoExostat Medical, Inc. — MicroTrend System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 7, 2024device 510k624d agoInrad, Inc. — Trilogy Tissue Marker (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 7, 2024device 510k624d agoSpident Co., Ltd. — VioSeal (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 7, 2024device 510k624d agoRebotix — Remanufactured EndoWrist ProGrasp Forceps (420093) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 7, 2024device 510k624d agoNeurocareai, Inc. — NeuroICH (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 7, 2024device 510k624d agoVarian Medical Systems, Inc. — Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical Sleeve (510k cleared)MERIT MEDICAL SYSTEMS INC

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

    full page →fda device 510k ↗
    ›Nov 7, 2024device 510k624d agoStryker Spine — OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal System; MESA® Small Stature Spinal System; CASPIAN® Spinal System; DENALI® Spinal System; DENALI® MI Spinal System; YUKON OCT Spinal System; Xia® 3 Spinal System; K2M Patient Specific; CASCADIA™ Interbody System; CAYMAN® Plate System; CAYMAN® Plate System-MI (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 7, 2024device 510k624d agoAspen Imaging Healthcare, Inc. — IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 7, 2024device 510k624d agoBiofire Diagnostics, LLC — BIOFIRE FILMARRAY Gastrointestinal (GI) Panel (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 7, 2024device 510k624d agoZsfab — ZSFab Cervical Interbody System; ZSFab Lumbar Interbody System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 7, 2024device 510k624d agoOssvis Co., Ltd. — LL Implant System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 7, 2024device 510k624d agoShenzhen Greatro Electronic Technology Co., Ltd. — Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 7, 2024device 510k624d agoFoundation Surgical Group, Inc. — Vertiwedge® Intraosseous System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 7, 2024device 510k624d agoMako Surgical Corp. — Mako Shoulder Application (1.0) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 7, 2024device 510k624d agoIcometrix NV — icobrain aria (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 7, 2024device 510k624d agoNewclip Technics — Newclip Patient-matched instrumentation non sterile PSI (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 8, 2024device 510k623d agoIcad, Inc. — ProFound Detection (V4.0) (510k cleared)

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

    full page →fda device 510k ↗
    $BSX43.58+1.42%
    $AEVA
    $MMSI73.110.00%
    $MDCE0.00020.00%