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5,000 catalysts · 18,987 approval · 5,811 phase readout · 5,000 device 510k · 4,728 grant · 2,984 8k filing · 2,000 device pma

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type: device 510k×clear all
type
  • approval18,987
  • phase readout5,811
  • device 510k5,000
  • grant4,728
  • 8k filing2,984
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • earnings572
  • therapy area

    no tagged catalysts yet

    Week of Mar 23, 2026

    50
    ›Mar 24, 2026device 510k138d agoShimadzu Corporation — Trinias (510k cleared)Shimadzu Corporation/ADR

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

    full page →fda device 510k ↗
    ›Mar 24, 2026device 510k138d agoBeckman Coulter, Inc. — Access BNP II (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 25, 2026device 510k137d agoSpectrum Vascular — Arterial Pressure Monitoring Set/Tray (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 25, 2026device 510k137d agoNvision Biomedical Technologies, Inc. — Vortex5 Tailor's Bunion Correction System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 25, 2026device 510k137d agoArthroCare Corporation — LYNX COBLATION Laryngeal Wand (72290254) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 25, 2026device 510k137d agoLetus Corporation — MiraChlor Antimicrobial Wound Solution (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 25, 2026device 510k137d agoAlphatec Spine, Inc. — Invictus Bands System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 25, 2026device 510k137d agoMedline Industries, LP — Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78” Infant Circuit, HUD99060KIT / Dri-Tech with 78” Infant Circuit Kit, HUD99001KIT / Single Limb Infant Circuit Dri-Tech Kit, HUD99009KIT / Dri-Tech with 60” Infant Circuit Kit, HUD99018KIT / Dri-Tech with 44” Infant Circuit Kit, HUD870NKIT / Dri-Tech Infant Accessory Bag, HUD1631 / Infant Wye Connector with Swivel) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 25, 2026device 510k137d agoNovastep SAS — Airlock® Ankle Plating System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 25, 2026device 510k137d agoZhuhai Wesee Meditech Co., Ltd. — Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B) (510k cleared)

    Product code: EOB. Advisory committee: Ear, Nose, Throat. Type: Traditional

    full page →fda device 510k ↗
    ›Mar 25, 2026device 510k137d agoSandstone Medical (Suzhou), Inc. — Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 25, 2026device 510k137d agoCurexo, Inc. — CUVIS-joint (CJ150) (510k cleared)Curevo Inc

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

    full page →fda device 510k ↗
    ›Mar 25, 2026device 510k137d agoSpinepoint, LLC — Flex-Z™ Cervical Cage (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 25, 2026device 510k137d agoMevion Medical Systems, Inc. — S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) (510k cleared)MERIT MEDICAL SYSTEMS INC

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

    full page →fda device 510k ↗
    ›Mar 25, 2026device 510k137d agoBausch and Lomb, Incorporated — Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 26, 2026device 510k136d agoLunit, Inc. — Lunit INSIGHT DBT (V1.2) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 26, 2026device 510k136d agoMedtronic Navigation, Inc. — Stealth AXiS Cranial clinical application (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 26, 2026device 510k136d agoVizaramed, Inc. — Multiflex Steerable Sheath 17.5F (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 26, 2026device 510k136d agoSurgify Medical OY — Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo (54.125.NVG.U1); Surgify Halo (54.000.SEE.U1); Surgify Halo (40.070.NVG.U1); Surgify Halo (40.125.NVG.U1); Surgify Halo (40.000.SEE.U1); Surgify Halo (30.070.NVG.U2); Surgify Halo (30.125.NVG.U2); Surgify Halo (30.000.SEE.U2) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 26, 2026device 510k136d agoBIOMERIEUX — VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 26, 2026device 510k136d agoBlue Belt Technologies, Inc. — REAL INTELLIGENCE™ CORI™ (510k cleared)BETA Technologies, Inc.

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

    full page →fda device 510k ↗
    ›Mar 26, 2026device 510k136d agoDevilbiss Healthcare, LLC — DeVilbiss 5 Liter Oxygen Concentrator (555) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 26, 2026device 510k136d agoShenzhen Urion Technology Co., Ltd. — Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Mar 26, 2026device 510k136d agoAirs Medical, Inc. — SwiftMR (510k cleared)AVITA Medical, Inc.

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

    full page →fda device 510k ↗
    ›Mar 26, 2026device 510k136d agoRestore Robotics — Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 27, 2026device 510k135d agoCanon Medical Systems Corporation — Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 27, 2026device 510k135d agoButterfly Network, Inc. — Butterfly Gestational Age Tool (510k cleared)Butterfly Network, Inc.

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

    full page →fda device 510k ↗
    ›Mar 27, 2026device 510k135d agoSS GLOBAL — CyClean Cord (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 27, 2026device 510k135d agoETHICON, Inc. — STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control Device (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 27, 2026device 510k135d agoSamsung Medison Co., Ltd. — EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10 Diagnostic Ultrasound System; EVO XQ30 Diagnostic Ultrasound System; EVO XQ20 Diagnostic Ultrasound System; EVO XQ10 Diagnostic Ultrasound System; EVO QH30 Diagnostic Ultrasound System; EVO QH20 Diagnostic Ultrasound System; EVO QH10 Diagnostic Ultrasound System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 27, 2026device 510k135d agoPhilips Ultrasound, LLC — EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 27, 2026device 510k135d agoVy Spine, LLC — VyPlate™ Anterior Cervical Plate System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 27, 2026device 510k135d agoFoshan Dahao Medical Technology Co., Ltd. — Electric wheelchair (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Mar 27, 2026device 510k135d agoMedcad — MedCAD® AccuStride™ System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 27, 2026device 510k135d agoStreck, LLC — MDx-Chex for BCP (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 27, 2026device 510k135d agoPhilips Medical Systems Technologies , Ltd. — Spectral CT Verida Family (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 27, 2026device 510k135d agoAmerican Medical Endoscopy, Inc. — Strauss Surgical cystoscope, hysteroscope and accessories Instruments (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 27, 2026device 510k135d agoEsaote, S.p.A. — S-scan Open (100001800) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 27, 2026device 510k135d agoAneuvo — ExaStim® Stimulation System (EXA-001); ExaStim® Stimulation System (EXA-011); ReCure® Electrode Pad (PAD-003); ReCure® Electrode Pad (PAD-013) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 27, 2026device 510k135d agoIcu Medical, Inc. — OTTO™ Disinfecting Cap (510k cleared)ICU MEDICAL INC/DE

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

    full page →fda device 510k ↗
    ›Mar 27, 2026device 510k135d agoBoston Scientific Corporation — Asurys Fluid Management System (510k cleared)BOSTON SCIENTIFIC CORP

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

    full page →fda device 510k ↗
    ›Mar 27, 2026device 510k135d agoSurgical Fusion Technologies GmbH — SF Push-in Anchor (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 27, 2026device 510k135d agoTerumo Corporation — Ryurei (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 27, 2026device 510k135d agoGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC — Automated Aortic Stenosis Software (AutoAS) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 27, 2026device 510k135d agoArtiness S.R.L — ARTICOR planner (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 27, 2026device 510k135d agoSynergy Spine Solutions, Inc. — Synergy Disc Instruments (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 27, 2026device 510k135d agoMim Software, Inc. — Contour ProtégéAI+ (510k cleared)ASURE SOFTWARE INC

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

    full page →fda device 510k ↗
    ›Mar 27, 2026device 510k135d agoNingbo Zhishan Medical Technology Co., Ltd. — Power wheelchair (ZS-EW8026) (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Mar 27, 2026device 510k135d agoYurob Rehabilitation Medical Co., Ltd. — Electrically Powered Wheelchair (Model YC-01) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 27, 2026device 510k135d agoMedos International SARL — SYMPHONY Navigation Ready Instruments (510k cleared)

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

    full page →fda device 510k ↗
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    $SHMXY11.810.00%
    $MMSI89.04+1.54%
    $BETA16.10+2.09%
    $BSX49.31+0.02%
    $ICUI184.56+10.93%
    $FRTRY
    $RCEL7.7700+63.58%
    $BFLY8.9000+55.87%
    $ASUR8.2700+1.35%