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476 catalysts · 3,230 8k filing · 1,368 grant · 1,000 device adverse event · 615 approval · 582 earnings · 476 device 510k

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2026-08-10: 0 catalysts2026-08-11: 0 catalysts2026-08-12: 0 catalysts2026-08-13: 60 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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type: device 510k×from 2026-02-24×clear all
type
  • 8k filing3,230
  • grant1,368
  • device adverse event1,000
  • approval615
  • earnings582
  • device 510k476
device pma
297
  • phase 2 completion172
  • drug shortage133
  • recall121
  • therapy area

    no tagged catalysts yet

    Week of Feb 23, 2026

    46
    ›Feb 24, 2026device 510k171d 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 510k171d 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 510k171d 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 510k171d 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 510k171d 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 510k171d agoOsteomni, Inc. — OSTEOMNI SPINAL FIXATION SYSTEM (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 24, 2026device 510k171d 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 510k171d agoOSSIO , Ltd. — OSSIOfiber® Suture Anchor (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 24, 2026device 510k171d 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 510k171d 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 510k171d 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 510k171d 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 510k170d 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 510k170d 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 510k170d 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 510k170d 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 510k170d agoGrindguard, Inc. — Remi Impression Material (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 25, 2026device 510k170d 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 510k170d 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 510k169d 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 510k169d 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 510k169d agoORO Co., Ltd. — CAPRI (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 26, 2026device 510k169d agoOsteonic Co., Ltd. — Aster (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 26, 2026device 510k169d agoImplanet — SWINGO-3D Lumbar Cage System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 26, 2026device 510k169d 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 510k169d 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 510k169d 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 510k169d 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 510k169d 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 510k169d 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 510k169d 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 510k169d 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 510k169d 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 510k169d agoEnbio Group AG — Enbio PRO (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 27, 2026device 510k168d agoHankil Tech Medical Co., Ltd. — HKT Anatomical Locking Trauma System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 27, 2026device 510k168d agoSiemens Healthcare Diagnostics, Inc. — Atellica CH Diazo Total Bilirubin (D_TBil) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 27, 2026device 510k168d agoBeijing HuaCheng Taike Technology Co., Ltd. — Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 27, 2026device 510k168d agoLigence Uab — Ligence Heart (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 27, 2026device 510k168d agoMediclus Co., Ltd. — One-Stop (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 27, 2026device 510k168d agoAvita Corporation — AViTA Pulse Oximeter (SP61) (510k cleared)Teva Pharmaceuticals USA Inc

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

    full page →fda device 510k ↗
    ›Feb 27, 2026device 510k168d agoElevate Oral Care — Allday Moisturizing Rinse (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 27, 2026device 510k168d agoBeijing HuaCheng Taike Technology Co., Ltd. — Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 27, 2026device 510k168d agoVigor Medical Technologies , Ltd. — C-Lant Port (510k cleared)KESTRA MEDICAL TECHNOLOGIES, LTD.

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

    full page →fda device 510k ↗
    ›Feb 27, 2026device 510k168d agoRiverpoint Medical, LLC — LigaMend (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 27, 2026device 510k168d agoEpineuron Technologies, Inc. — Evala Nerve Stimulator (EPNR002) (510k cleared)Exyn Technologies, Inc.

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

    full page →fda device 510k ↗
    ›Feb 27, 2026device 510k168d agoAtraverse Medical — HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) (510k cleared)

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

    full page →fda device 510k ↗

    Week of Mar 2, 2026

    4
    ›Mar 2, 2026device 510k165d agoNanjing Dewen Medical Technology Co., Ltd. — Microwave Ablation Device (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Mar 2, 2026device 510k
    ← prev
    page 1 of 10
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    165d ago
    Karl Storz SE & CO. KG — KARL STORZ Mediastinoscopes and Instruments (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 2, 2026device 510k165d agoNanjing Devin Medical Technology Co., Ltd. — Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14, DW-XR-II5, DW-XR-II6, DW-XR-II7, DW-XR-II8, DW-XR-II9, DW-XR-II10, DW-XR-II18, DW-XR-II19, DW-XR-II20, DW-XR-II21, DW-DG-II6, DW-DG-II7, DW-DG-II9, DW-DG-II10, DW-DG-II13) (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Mar 2, 2026device 510k165d agoClarius Mobile Health Corp. — Clarius Ejection Fraction AI (510k cleared)

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

    full page →fda device 510k ↗
    $EW91.33-2.47%
    $CIX23.11+2.78%
    $ICCM0.2280+3.64%
    $ISRG400.24-0.26%
    $BDX183.58+1.20%
    $GMED79.93+1.27%
    $KMTS20.35+8.13%
    $EXYN4.3000-14.00%