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526 catalysts · 3,350 8k filing · 1,425 grant · 1,000 device adverse event · 662 approval · 582 earnings · 526 device 510k

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2026-08-10: 0 catalysts2026-08-11: 0 catalysts2026-08-12: 0 catalysts2026-08-13: 0 catalysts2026-08-14: 0 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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type: device 510k×from 2026-02-19×clear all
type
  • 8k filing3,350
  • grant1,425
  • device adverse event1,000
  • approval662
  • earnings582
  • device 510k526
device pma
329
  • phase 2 completion172
  • drug shortage133
  • recall121
  • therapy area

    no tagged catalysts yet

    Week of Feb 16, 2026

    34
    ›Feb 19, 2026device 510k178d 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 510k178d 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 510k178d 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 510k178d 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 510k178d 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 510k178d 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 510k178d agoSilony Medical GmbH — VERTICALE GPS Instruments (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 19, 2026device 510k178d 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 510k178d 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 510k178d 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 510k178d 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 510k178d agoLacerta Life Sciences — LacertaMatrix (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 19, 2026device 510k178d 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 510k178d 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 510k178d 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 510k178d 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 510k178d 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 510k178d agoCenterPoint Systems, LLC — AuST CSP Introducer (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 20, 2026device 510k177d 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 510k177d 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 510k177d 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 510k177d agoCepheid — Xpert Hemorrhagic Fever (510k cleared)

    Advisory committee: Unknown. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 20, 2026device 510k177d 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 510k177d 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 510k177d 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 510k177d 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 510k177d 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 510k177d agoCara Medical, Ltd. — CARA System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 20, 2026device 510k177d 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 510k177d 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 510k177d 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 510k177d agoQstag, Inc. — QSCHECK UISACR (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 21, 2026device 510k176d 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 510k175d 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

    16
    ›Feb 23, 2026device 510k174d 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
    next →
    174d 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 ↗
    ›Feb 23, 2026device 510k174d agoXenix Medical — LUX Expandable Lumbar Interbody System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 23, 2026device 510k174d agoResmed Pty , Ltd. — Mariana Minerva; Mariana Nimbus (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 23, 2026device 510k174d agoBox Spine, LLC — Duet™ Spinal Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 23, 2026device 510k174d agoSiemens Shenzhen Magnetic Resonance , Ltd. — MAGNETOM Flow.Ace; MAGNETOM Flow.Plus (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 23, 2026device 510k174d agoArgon Medical Devices, Inc. — ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863212130 / ZeniCore Automatic Biopsy Device 12ga x 13cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214100 / ZeniCore Automatic Biopsy Device 14ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214130 / ZeniCore Automatic Biopsy Device 14ga x 13cm with Coaxial (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 23, 2026device 510k174d agoSmart Reactors — Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 23, 2026device 510k174d agoC.R. Bard, Inc. — Rubber Utility Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 23, 2026device 510k174d agoPhilips Medical Systems Nederland B.V. — Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 23, 2026device 510k174d agoCMT Health PTE., Ltd. — Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe (510k cleared)Shanghai Jiao Tong University

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

    full page →fda device 510k ↗
    ›Feb 23, 2026device 510k174d agoApplied Medical Resources Corporation — Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 23, 2026device 510k174d agoShenzhen Mlay Intelligent Technology Co., Ltd. — IPL Hair Removal Device (Models: T31A, T32A) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 23, 2026device 510k174d agoJiangsu Yuyue Medical Equipment & Supply Co., Ltd. — YUWELL® Electronic Blood Pressure Monitor (YE650AR) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 23, 2026device 510k174d agoZhejiang Wei Ling New Energy Technology Co., Ltd. — Mobility Scooter (CL-Q3, CL-Q4) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 23, 2026device 510k174d agoSkia, Inc. — SKIA-Head (Model: SKIA-ST00) (510k cleared)

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

    full page →fda device 510k ↗
    $MDT91.27+0.76%
    $MDCE0.00020.00%