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492 catalysts · 3,590 8k filing · 1,378 grant · 1,000 device adverse event · 644 approval · 583 earnings · 492 device 510k

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2026-08-24: 0 catalysts2026-08-25: 0 catalysts2026-08-26: 0 catalysts2026-08-27: 0 catalysts2026-08-28: 17 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: 1 catalyst2026-10-01: 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 catalysts2026-11-16: 0 catalysts2026-11-17: 0 catalysts2026-11-18: 0 catalysts2026-11-19: 0 catalysts2026-11-20: 0 catalysts2026-11-21: 0 catalysts2026-11-22: 0 catalysts
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type: device 510k×from 2026-02-23×clear all
type
  • 8k filing3,590
  • grant1,378
  • device adverse event1,000
  • approval644
  • earnings583
  • device 510k492
device pma
302
  • phase 2 completion172
  • drug shortage133
  • recall121
  • therapy area

    no tagged catalysts yet

    Week of Feb 23, 2026

    50
    ›Feb 23, 2026device 510k187d 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 510k187d agoVita 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 510k187d 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 510k187d 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 510k187d 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 510k187d 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 510k187d 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 510k187d 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 510k187d 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 510k187d 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 510k187d 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 510k187d 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 510k187d 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 510k187d 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 510k187d 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 510k187d agoSkia, Inc. — SKIA-Head (Model: SKIA-ST00) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 24, 2026device 510k186d agoEdwards Lifesciences, LLC — HemoSphere Nano Monitor (HSNANO1) (510k cleared)Edwards Lifesciences Corp

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

    full page →fda device 510k ↗
    ›Feb 24, 2026device 510k186d agoExo Imaging — AI Platform 2.2 (AIP002) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 24, 2026device 510k186d agoPhilips Image Guided Therapy Corporation — IntraSight Plus (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 24, 2026device 510k186d agoIceCure Medical , Ltd. — XSense Cryoablation System with CryoProbes (510k cleared)IceCure Medical Ltd.

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

    full page →fda device 510k ↗
    ›Feb 24, 2026device 510k186d agoShenzhen Zhimahuaerkai Technology Co., Ltd. — Electric wheelchair (W1,W3) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 24, 2026device 510k186d agoOsteomni, Inc. — OSTEOMNI SPINAL FIXATION SYSTEM (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 24, 2026device 510k186d agoIntuitive Surgical, Inc. — Universal Seal (5-12 mm) (510k cleared)INTUITIVE SURGICAL INC

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

    full page →fda device 510k ↗
    ›Feb 24, 2026device 510k186d agoOSSIO , Ltd. — OSSIOfiber® Suture Anchor (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 24, 2026device 510k186d agoWingderm Electro-Optics , Ltd. — Diode Laser Therapy Systems (WLA-02) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 24, 2026device 510k186d agoSingle Pass, Inc. — SP Electrocautery Device (SP20) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 24, 2026device 510k186d agoSwift Medical, Inc. — Swift Ray 1 (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 24, 2026device 510k186d agoMego Afek , Ltd. — NanoPress 760A-BT (760A-BT) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 25, 2026device 510k185d agoBecton, Dickinson and Company (BD) — BD Surgiphor™ Antimicrobial Irrigation System (910110) (510k cleared)BECTON DICKINSON & CO

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

    full page →fda device 510k ↗
    ›Feb 25, 2026device 510k185d agoSpinal Elements, Inc. — Ventana™ A Anterior Lumbar Interbody System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 25, 2026device 510k185d agoZhejiang Yikang Medical Technology Co., Ltd. — Electric wheelchair (510k cleared)Zhejiang Xinkanghe Biomedical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Feb 25, 2026device 510k185d agoMedline Industries, LP — Konig Bell Circumcision Clamp (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 25, 2026device 510k185d agoGrindguard, Inc. — Remi Impression Material (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 25, 2026device 510k185d agoMako Surgical Corp. — Mako Total Knee Application (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 25, 2026device 510k185d agoMighty Oak Medical — FIREFLY® Pedicle Screw Navigation Guide (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 26, 2026device 510k184d agoSibel Health, Inc. — ANNE Maternal (510k cleared)Seed Health Inc

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

    full page →fda device 510k ↗
    ›Feb 26, 2026device 510k184d agoGlobus Medical, Inc. — RIB LINK™ Fixation System (510k cleared)GLOBUS MEDICAL INC

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

    full page →fda device 510k ↗
    ›Feb 26, 2026device 510k184d agoORO Co., Ltd. — CAPRI (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 26, 2026device 510k184d agoOsteonic Co., Ltd. — Aster (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 26, 2026device 510k184d agoImplanet — SWINGO-3D Lumbar Cage System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 26, 2026device 510k184d agoMedacta International S.A. — GMK 3D Metal Tibial Tray Extension (510k cleared)Stemedica International S.A.

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

    full page →fda device 510k ↗
    ›Feb 26, 2026device 510k184d agoKarl Storz SE & CO. KG — KARL STORZ ICG Imaging System with RUBINA® Lens (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 26, 2026device 510k184d agoShanghai AnQing Medical Instrument Co., Ltd. — InnovexView (GC146-17, GC150-20, GC155-23) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 26, 2026device 510k184d agoAidoc Medical , Ltd. — BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 26, 2026device 510k184d agoDePuy Mitek, Inc. — PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System Lid (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 26, 2026device 510k184d agoCopioumed International, Inc. — Copioumed AAMI 3 Surgical Gown (510k cleared)COMPX INTERNATIONAL INC

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

    full page →fda device 510k ↗
    ›Feb 26, 2026device 510k184d agoOwl Dental Lab, Inc. — Owl Night Guard (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 26, 2026device 510k184d agoDisior, Ltd. — ENOS Software Guided External Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 26, 2026device 510k184d agoSpeciality Fibres and Materials Limited — Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG100400); Ganymede 10cm x 10cm (FG100500); Ganymede 15cm x 15cm (FG100600); Ganymede 20cm x 30cm (FG100700); Ganymede 25cm x 25cm (FG100800); Ganymede 30cm x 30cm (FG100900); Ganymede 40cm x 40cm (FG100999); Ganymede 7.5cm x 120cm (FG100100); Ganymede-X 2cm diameter (FG100301); Ganymede-X 5cm x 5cm (FG100401); Ganymede-X 10cm x 10cm (FG100501); Ganymede-X 15cm x 15cm (FG100601); Ganymede-X 20cm x 30cm (FG100701); Ganymede-X 25cm (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 26, 2026device 510k184d agoEnbio Group AG — Enbio PRO (510k cleared)

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

    full page →fda device 510k ↗
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    $EW91.33-2.47%
    $BDX188.13-1.09%
    $ISRG370.42-0.38%
    $GMED79.93+1.27%
    $ICCM0.2280+3.64%
    $CIX23.11+2.78%