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calendar

4,365 catalysts · 4,728 grant · 4,365 device 510k · 3,359 8k filing · 3,180 approval · 2,000 device pma · 2,000 device recall

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2026-08-17: 10 catalysts2026-08-18: 2 catalysts2026-08-19: 3 catalysts2026-08-20: 0 catalysts2026-08-21: 0 catalysts2026-08-22: 0 catalysts2026-08-23: 0 catalysts2026-08-24: 0 catalysts2026-08-25: 0 catalysts2026-08-26: 1 catalyst2026-08-27: 1 catalyst2026-08-28: 0 catalysts2026-08-29: 0 catalysts2026-08-30: 0 catalysts2026-08-31: 0 catalysts2026-09-01: 1 catalyst2026-09-02: 0 catalysts2026-09-03: 1 catalyst2026-09-04: 0 catalysts2026-09-05: 0 catalysts2026-09-06: 0 catalysts2026-09-07: 0 catalysts2026-09-08: 0 catalysts2026-09-09: 0 catalysts2026-09-10: 0 catalysts2026-09-11: 0 catalysts2026-09-12: 0 catalysts2026-09-13: 0 catalysts2026-09-14: 0 catalysts2026-09-15: 0 catalysts2026-09-16: 0 catalysts2026-09-17: 0 catalysts2026-09-18: 0 catalysts2026-09-19: 0 catalysts2026-09-20: 0 catalysts2026-09-21: 0 catalysts2026-09-22: 0 catalysts2026-09-23: 2 catalysts2026-09-24: 0 catalysts2026-09-25: 0 catalysts2026-09-26: 0 catalysts2026-09-27: 0 catalysts2026-09-28: 0 catalysts2026-09-29: 0 catalysts2026-09-30: 0 catalysts2026-10-01: 0 catalysts2026-10-02: 0 catalysts2026-10-03: 0 catalysts2026-10-04: 0 catalysts2026-10-05: 0 catalysts2026-10-06: 0 catalysts2026-10-07: 0 catalysts2026-10-08: 2 catalysts2026-10-09: 0 catalysts2026-10-10: 0 catalysts2026-10-11: 0 catalysts2026-10-12: 0 catalysts2026-10-13: 1 catalyst2026-10-14: 1 catalyst2026-10-15: 0 catalysts2026-10-16: 0 catalysts2026-10-17: 0 catalysts2026-10-18: 0 catalysts2026-10-19: 1 catalyst2026-10-20: 2 catalysts2026-10-21: 2 catalysts2026-10-22: 2 catalysts2026-10-23: 1 catalyst2026-10-24: 0 catalysts2026-10-25: 0 catalysts2026-10-26: 1 catalyst2026-10-27: 8 catalysts2026-10-28: 12 catalysts2026-10-29: 21 catalysts2026-10-30: 4 catalysts2026-10-31: 0 catalysts2026-11-01: 0 catalysts2026-11-02: 9 catalysts2026-11-03: 18 catalysts2026-11-04: 22 catalysts2026-11-05: 37 catalysts2026-11-06: 2 catalysts2026-11-07: 0 catalysts2026-11-08: 0 catalysts2026-11-09: 1 catalyst2026-11-10: 0 catalysts2026-11-11: 0 catalysts2026-11-12: 0 catalysts2026-11-13: 0 catalysts2026-11-14: 0 catalysts2026-11-15: 0 catalysts
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type: device 510k×from 2024-12-06×clear all
type
  • grant4,728
  • device 510k4,365
  • 8k filing3,359
  • approval3,180
  • device pma2,000
  • device recall2,000
recall
1,064
  • device adverse event1,000
  • earnings584
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Dec 2, 2024

    26
    ›Dec 6, 2024device 510k620d agoPeek Health, S.A. — PeekMed web (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 6, 2024device 510k620d agoPiraeus Medical — 87 NeuGlide Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 6, 2024device 510k620d agoAbbott Molecular — Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 6, 2024device 510k620d agoSyntheticmr AB (Publ.) — SyMRI (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 6, 2024device 510k620d agoShenzhen Dazhou Medical Technology Co., Ltd. — DZ-Tabone Intervertebral Body Fusion Device (510k cleared)Guangzhou Dazhou Biomedical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Dec 6, 2024device 510k620d agoNeuraxis, Inc. — RED (510k cleared)Neuraxis, INC

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

    full page →fda device 510k ↗
    ›Dec 6, 2024device 510k620d agoProject Chemistry, Inc. — INA Moisturizing Intimate Lubricant Water-Based Personal Lubricant (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 6, 2024device 510k620d agoFoshan Care Medical Technology Co., Ltd. — Oxygen Concentrator (ZY-10AB/115) (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Dec 6, 2024device 510k620d agoOxford Brain Diagnostics, Ltd. — CDM Insights (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 6, 2024device 510k620d agoEver Fortune.Ai, Co., Ltd. — EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 6, 2024device 510k620d agoShenzhen Jianchao Intelligent Technology Co., Ltd. — Hair Removal Device (R3C16-P, R3C16-W, R3C16-G, R3C16-P Pro, R3C16-W Pro, R3C16-G Pro, R3505-W, R3505-B, R3505-W Pro, R3505-B Pro) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 6, 2024device 510k620d agoPentax of America, Inc. — PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 6, 2024device 510k620d agoAngioDynamics, Inc. — NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090); NanoKnife Single Electrode Activation Probe, 25 cm (H787204001100); NanoKnife Single Electrode Probe Spacer (H787204003010) (510k cleared)ANGIODYNAMICS INC

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

    full page →fda device 510k ↗
    ›Dec 6, 2024device 510k620d agoVinbrain Joint Stock Company — DrAid™ for Liver Segmentation (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 6, 2024device 510k620d agoAmes Medical Prosthetic Solutions, S.A.U. — OsteoSinter® EVANS and COTTON wedges and related accessories (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 6, 2024device 510k620d agoOxos Medical — MC2 Portable X-ray System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 6, 2024device 510k620d agoBard Peripheral Vascular, Inc. — PeritX™ 1L Drainage Kit (90-1010); PeritX™ 2L Drainage Kit (90-2010); PeritX™ Peritoneal Catheter Kit (50-9000C); PeritX™ Peritoneal Catheter and Starter Kit (50-9900C); PeritX™ Peritoneal Catheter Mini Kit (50-9050A); PleurX™ Low Profile Catheter Mini Kit (50-8050); Valve Cap (50-7235A); PeritX™ Valve Kit (50-7272); Catheter Access Kit (50-7280A); Lockable Drainage Line (50-7245A); Lockable Drainage Line Kit (50-7265A); PleurX™ Supplemental Insertion Kit (50-7262); Procedure Pack (50- (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 6, 2024device 510k620d agoStryker Corporation (Tornier, Inc.) — Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 6, 2024device 510k620d agoCercare Medical A/S — Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 6, 2024device 510k620d agoMolecular Products , Ltd. — Rugged Oxygen Generator (ROG) (RO01-00001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 6, 2024device 510k620d agoGS Medical Co., Ltd. — AnyPlus Navigated Instruments System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 6, 2024device 510k620d agoBoston Scientific — WallFlex Biliary PLUS RX Stent System (510k cleared)BOSTON SCIENTIFIC CORP

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

    full page →fda device 510k ↗
    ›Dec 6, 2024device 510k620d agoYukon Medical, LLC — SmartSiteTM Vented Vial Access Device (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 6, 2024device 510k620d agoGlobus Medical, Inc. — ACTIFY™ Unicondylar Knee System (510k cleared)GLOBUS MEDICAL INC

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

    full page →fda device 510k ↗
    ›Dec 6, 2024device 510k620d agoLake Region Medical — PTFE Guidewire (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 8, 2024device 510k618d agoSomnomedics GmbH — HomeSleepTest (HST, HST REM+) (510k cleared)

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

    full page →fda device 510k ↗

    Week of Dec 9, 2024

    24
    ›Dec 9, 2024device 510k617d agoEdwards Lifesciences — HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100) (510k cleared)Edwards Lifesciences Corp

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

    full page →fda device 510k ↗
    ›Dec 9, 2024device 510k
    ← prev
    page 1 of 88
    next →
    617d ago
    Hartmann USA, Inc. — Atrauman® Ag (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 9, 2024device 510k617d agoVerily Life Sciences, LLC — Verily Numetric Retinal Camera (510k cleared)TAE Life Sciences LLC

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

    full page →fda device 510k ↗
    ›Dec 9, 2024device 510k617d agoShenzhen Browiner Tech Co., Ltd. — Digital Radiography System (ManntiX B, ManntiX K) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 9, 2024device 510k617d agoGanshorn Medizin Electronic GmbH — PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 9, 2024device 510k617d agoSmith & Nephew, Inc. — TRIGEN META-TAN Trochanteric Antegrade Nail (510k cleared)SMITH & NEPHEW PLC

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

    full page →fda device 510k ↗
    ›Dec 9, 2024device 510k617d agoRadformation, Inc. — AutoContour (Model RADAC V4) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 10, 2024device 510k616d agoInstitut Straumann AG — Straumann® PURE Ceramic Implants (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 10, 2024device 510k616d agoIntuitive Surgical, Inc. — IRISeg (510k cleared)INTUITIVE SURGICAL INC

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

    full page →fda device 510k ↗
    ›Dec 10, 2024device 510k616d agoCarestream Health, Inc. — DRX-Revolution Mobile X-ray System (510k cleared)HEALTHSTREAM INC

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

    full page →fda device 510k ↗
    ›Dec 10, 2024device 510k616d agoJeisys Medical, Inc. — POTENZA (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 10, 2024device 510k616d agoConcourse Assistive Technology Pty, Ltd. — Empulse M90 (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 10, 2024device 510k616d agoAerin Medical, Inc. — Aerin Console (510k cleared)AETHLON MEDICAL INC

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

    full page →fda device 510k ↗
    ›Dec 10, 2024device 510k616d agoPhilips Medical Systems Nederland B.V. — Philips IntelliSite Pathology Solution 5.1 (510k cleared)

    Product code: PSY. Advisory committee: Pathology. Type: Traditional

    full page →fda device 510k ↗
    ›Dec 10, 2024device 510k616d agoElos Medtech Pinol A/S — Elos Accurate® Hybrid Base™ (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 10, 2024device 510k616d agoMerit Medical Systems, Inc. — Prelude Small O.D. Introducer Guide Wire (510k cleared)MERIT MEDICAL SYSTEMS INC

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

    full page →fda device 510k ↗
    ›Dec 10, 2024device 510k616d agoAnalog Devices — Sensinel Cardiopulmonary Management (CPM) System (ADCP1100) (510k cleared)ANALOG DEVICES INC

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

    full page →fda device 510k ↗
    ›Dec 10, 2024device 510k616d agoSamsung Medison Co., Ltd. — V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultrasound System, V4 Diagnostic Ultrasound System, H4 Diagnostic Ultrasound System, XV4 Diagnostic Ultrasound System, XH4 Diagnostic Ultrasound System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 10, 2024device 510k616d agoShantou Institute of Ultrasonic Instruments Co., Ltd. — Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler Ultrasound Imaging System (Readius P8); Digital Color Doppler Ultrasound Imaging System (Readius V6); Digital Color Doppler Ultrasound Imaging System (Readius C6) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 11, 2024device 510k615d agoVarian Medical Systems — Eclipse Treatment Planning System (18.1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 11, 2024device 510k615d agoMicrogenics Corporation — Alinity c Benzodiazepines Reagent Kit (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 11, 2024device 510k615d agoMonarch Medical Technologies — EndoTool IV (3.1) (510k cleared)Medical Care Technologies Inc.

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

    full page →fda device 510k ↗
    ›Dec 11, 2024device 510k615d agoRafael Medical Devices, LLC — VECTR – Video Endoscopic Carpal Tunnel Release System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 11, 2024device 510k615d agoLife Spine, Inc. — Cervical Plating System (510k cleared)

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

    full page →fda device 510k ↗
    $EW91.33-2.47%
    $ANGO13.82-2.81%
    $GMED79.93+1.27%
    $NRXS
    $BSX51.83+0.27%
    $SNN29.81-1.00%
    $HSTM
    $AEMD
    $MMSI90.76+0.29%
    $ISRG394.51-1.68%
    $ADI
    $MDCE0.00020.00%