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23,239 catalysts · 4,900 device 510k · 4,728 grant · 3,532 approval · 3,288 8k filing · 2,000 device pma · 2,000 device recall

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2026-08-10: 0 catalysts2026-08-11: 0 catalysts2026-08-12: 0 catalysts2026-08-13: 118 catalysts2026-08-14: 4 catalysts2026-08-15: 0 catalysts2026-08-16: 0 catalysts2026-08-17: 1 catalyst2026-08-18: 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 catalysts
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  • device 510k4,900
  • grant4,728
  • approval3,532
  • 8k filing3,288
  • device pma2,000
  • device recall2,000
recall
1,126
  • device adverse event1,000
  • earnings584
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Dec 2, 2024

    26
    ›Dec 6, 2024device 510k616d agoPeek Health, S.A. — PeekMed web (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 6, 2024device 510k616d agoPiraeus Medical — 87 NeuGlide Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 6, 2024device 510k616d 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 510k616d agoSyntheticmr AB (Publ.) — SyMRI (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 6, 2024device 510k616d 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 510k616d agoNeuraxis, Inc. — RED (510k cleared)Neuraxis, INC

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

    full page →fda device 510k ↗
    ›Dec 6, 2024device 510k616d 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 510k616d 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 510k616d agoOxford Brain Diagnostics, Ltd. — CDM Insights (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 6, 2024device 510k616d 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 510k616d 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 510k616d 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 510k616d 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 510k616d 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 510k616d 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 510k616d 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 510k616d 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 510k616d 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 510k616d 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 510k616d 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 510k616d 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 510k616d 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 510k616d 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 510k616d 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 510k616d agoLake Region Medical — PTFE Guidewire (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 8, 2024device 510k614d 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, 2024approval613d agoOZEMPIC (SEMAGLUTIDE) — FDA approvalNovo Nordisk AS

    Sponsor: NOVO. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Dec 9, 2024approval
    ← prev
    page 20 of 465
    next →
    613d ago
    OZEMPIC (SEMAGLUTIDE) — FDA approvalNovo Nordisk AS

    Sponsor: NOVO. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Dec 9, 2024approval613d agoERTUGLIFLOZIN — FDA approvalERTUGLIFLOZIN

    Sponsor: AUROBINDO PHARMA LTD. Form: TABLET. Route: ORAL

    full page →ERTUGLIFLOZIN →fda approvals ↗
    ›Dec 9, 2024approval613d agoPREGABALIN — FDA approvalPREGABALIN

    Sponsor: STRIDES PHARMA. Form: CAPSULE. Route: ORAL

    full page →PREGABALIN →fda approvals ↗
    ›Dec 9, 2024device 510k613d 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 510k613d agoHartmann USA, Inc. — Atrauman® Ag (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 9, 2024device 510k613d 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 510k613d 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 510k613d 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 510k613d 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 510k613d agoRadformation, Inc. — AutoContour (Model RADAC V4) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 10, 2024approval612d agoACTEMRA (TOCILIZUMAB) — FDA approvaltocilizumab

    Sponsor: GENENTECH. Form: INJECTABLE. Route: INJECTION

    full page →tocilizumab →fda approvals ↗
    ›Dec 10, 2024approval612d agoACTEMRA (TOCILIZUMAB) — FDA approvaltocilizumab

    Sponsor: GENENTECH. Form: INJECTABLE. Route: INTRAVENOUS, SUBCUTANEOUS

    full page →tocilizumab →fda approvals ↗
    ›Dec 10, 2024approval612d agoHEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (HEPARIN SODIUM) — FDA approvalHEPARIN SODIUM

    Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

    full page →HEPARIN SODIUM →fda approvals ↗
    ›Dec 10, 2024device 510k612d 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 510k612d 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 510k612d 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 510k612d agoJeisys Medical, Inc. — POTENZA (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 10, 2024device 510k612d 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 510k612d 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 510k612d 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 510k612d 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 510k612d 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 510k612d 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 ↗
    $NRXS
    $GMED79.93+1.27%
    $ANGO13.82-2.81%
    $BSX51.69+0.53%
    $HSTM
    $ISRG401.270.00%
    $SNN30.00+0.55%
    $AEMD
    $EW91.33-2.47%
    $MMSI90.50-0.77%
    $ADI