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calendar

540 catalysts · 3,369 8k filing · 1,458 grant · 1,000 device adverse event · 701 approval · 582 earnings · 540 device 510k

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2026-08-17: 20 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 2026-02-17×clear all
type
  • 8k filing3,369
  • grant1,458
  • device adverse event1,000
  • approval701
  • earnings582
  • device 510k540
device pma
346
  • phase 2 completion172
  • recall157
  • drug shortage133
  • therapy area

    no tagged catalysts yet

    Week of Feb 16, 2026

    48
    ›Feb 17, 2026device 510k182d agoBiomendex OY — Adaptos®Fuse Bone Graft (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 17, 2026device 510k182d agoLiquet Medical, Inc. — Versus™ Catheter (VS110-9NB) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 17, 2026device 510k182d agoJiangsu Yuyue Medical Equipment & Supply Co., Ltd. — YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 17, 2026device 510k182d agoBiocomposites, Ltd. — Biosteon® Screw (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 17, 2026device 510k182d agoFujifilm Corporation — FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit (510k cleared)Fujifilm Holdings Corp

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

    full page →fda device 510k ↗
    ›Feb 17, 2026device 510k182d agoNingbo Shenyu Medical Equipment Co.,Ltd — Electric Wheelchair (W-A807, W-A807L) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 17, 2026device 510k182d agoCenterline Biomedical, Inc. — IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Simple Curve Catheter, 125cm (C01251); IOPS Viewpoint Double Curve Catheter, 75cm (C00752); IOPS Viewpoint Double Curve Catheter, 125cm (C02152); IOPS Guidewire 2 (ATW-2); IOPS Fiducial Tracking Pad (T02111); IOPS Guidewire Handle (H01035) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 18, 2026device 510k181d agoStryker Endoscopy — 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 18, 2026device 510k181d agoAxis-Shield Diagnostics, Ltd. — Alere NT-proBNP for Alinity i (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 18, 2026device 510k181d agoBTL Industries, Inc. — BTL-754FF (510k cleared)NL INDUSTRIES INC

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

    full page →fda device 510k ↗
    ›Feb 18, 2026device 510k181d agoNobel Biocare AB — Nobel Biocare S Series Implants (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 18, 2026device 510k181d agoHowmedica Osteonics Corp., Dba Stryker Orthopaedics — Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 18, 2026device 510k181d agoShenzhen Zhimahuaerkai Technology Co., Ltd. — Mobility Scooter (S3) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 18, 2026device 510k181d agoMethyl Co., Ltd. — PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 19, 2026device 510k180d agoMiRus, LLC — ATLAS™ Expandable Osteotomy Wedge System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 19, 2026device 510k180d agoErchonia Corporation — Erchonia DPN Laser (Model# EVRL) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 19, 2026device 510k180d agoAlphatec Spine, Inc. — Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 19, 2026device 510k180d agoGM Dos Reis Industria e Comercio Ltda. — Meniscus Versaflex (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 19, 2026device 510k180d agoEsthetic Medical, Inc. — SkinStylus SteriLock MicroSystem (MP1209SL) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 19, 2026device 510k180d agoAS Software, LLC — AS Software Version Asera (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 19, 2026device 510k180d agoSilony Medical GmbH — VERTICALE GPS Instruments (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 19, 2026device 510k180d agoElekta Solutions AB — Monaco RTP System (6.3) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 19, 2026device 510k180d agoEfofex, Inc. — Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 19, 2026device 510k180d agoBeckman Coulter, Inc. — Access anti-HBc Total (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 19, 2026device 510k180d agoGuilin Refine Medical Instrument Co., Ltd. — Portable Dental X-ray Device (GT-1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 19, 2026device 510k180d agoLacerta Life Sciences — LacertaMatrix (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 19, 2026device 510k180d agoStryker Leibinger GmbH & Co KG — Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update; Spine Guidance 5.4 Software Enable; Spine Guidance 5.4 Sales Demo; Q Drill Tracker; NavLock Adapter; Elite Q Attacments; Elite Cutting Accessories; Maestro Air Motor (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 19, 2026device 510k180d agoAcclarent, Inc. — Acclarent AERA Eustachian Tube Balloon Dilation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 19, 2026device 510k180d agoCMT Health PTE., Ltd. — Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe; Profoject™ Low Dead Space Syringe with Needle /Profoject™ Tuberculin Syringe with Needle; Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle; Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety Syringe (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 19, 2026device 510k180d agoAdaptiiv Medical Technologies, Inc. — TrueFit Bolus (510k cleared)Medical Care Technologies Inc.

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

    full page →fda device 510k ↗
    ›Feb 19, 2026device 510k180d agoMedtronic, Inc. — Retrograde Coronary Sinus Perfusion Cannulae (510k cleared)Medtronic plc

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

    full page →fda device 510k ↗
    ›Feb 19, 2026device 510k180d agoCenterPoint Systems, LLC — AuST CSP Introducer (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 20, 2026device 510k179d agoSoterix Medical, Inc. — SPRY TMS Therapy System (0550) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 20, 2026device 510k179d agoForeo, Inc. — FAQ™ (LED Panel); FAQ™ (Dual LED Panel) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 20, 2026device 510k179d agoKLS Martin L.P. — KLS Martin Ixos System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 20, 2026device 510k179d agoCepheid — Xpert Hemorrhagic Fever (510k cleared)

    Advisory committee: Unknown. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 20, 2026device 510k179d agoIntertape Polymer Group — LF Process Indicator Tape for Steam Sterilization (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 20, 2026device 510k179d agoZhejiang Chuangxiang Medical Technology Co., Ltd. — Disposable Ureteral Stents (510k cleared)Zhejiang Xinkanghe Biomedical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Feb 20, 2026device 510k179d agoBd — BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 20, 2026device 510k179d agoPoint Robotics MedTech, Inc. — “POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories Set (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 20, 2026device 510k179d agoNingbo Medsun Medical Co., Ltd. — Safety Heel Lancet (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 20, 2026device 510k179d agoCara Medical, Ltd. — CARA System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 20, 2026device 510k179d agoKLS-Martin L.P. — KLS Martin Pure Pectus System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 20, 2026device 510k179d agoCasebioscience, Inc. — CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5) (510k cleared)BJ Bioscience Inc

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

    full page →fda device 510k ↗
    ›Feb 20, 2026device 510k179d agoBiosense Webster, Inc. — CARTO™ 3 EP Navigation System V8.4 (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 20, 2026device 510k179d agoQstag, Inc. — QSCHECK UISACR (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 21, 2026device 510k178d agoMicro-Tech (Nanjing) Co., Ltd. — Advanced Tissue Resection Device (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 22, 2026device 510k177d agoOlympus Medical Systems Corp. — Single Use Distal Cover MAJ-2315 (MAJ-2315) (510k cleared)

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

    full page →fda device 510k ↗

    Week of Feb 23, 2026

    2
    ›Feb 23, 2026device 510k176d agoPoskom Co., Ltd. — AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 23, 2026device 510k
    ← prev
    page 1 of 11
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    176d ago
    Vita Zahnfabrik H. Rauter GmbH & Co. Kg. — VITA VMLC Primer (510k cleared)

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

    full page →fda device 510k ↗
    $MDCE0.00020.00%
    $NL6.0500-1.14%
    $MDT91.06-0.23%