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5,000 catalysts · 18,987 approval · 5,811 phase readout · 5,000 device 510k · 4,728 grant · 2,966 8k filing · 2,000 device pma

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2026-08-03: 0 catalysts2026-08-04: 0 catalysts2026-08-05: 0 catalysts2026-08-06: 0 catalysts2026-08-07: 16 catalysts2026-08-08: 0 catalysts2026-08-09: 0 catalysts2026-08-10: 11 catalysts2026-08-11: 6 catalysts2026-08-12: 13 catalysts2026-08-13: 11 catalysts2026-08-14: 3 catalysts2026-08-15: 0 catalysts2026-08-16: 0 catalysts2026-08-17: 1 catalyst2026-08-18: 2 catalysts2026-08-19: 0 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: 0 catalysts2026-08-28: 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: 0 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: 9 catalysts2026-10-29: 17 catalysts2026-10-30: 4 catalysts2026-10-31: 0 catalysts2026-11-01: 0 catalysts
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type: device 510k×clear all
type
  • approval18,987
  • phase readout5,811
  • device 510k5,000
  • grant4,728
  • 8k filing2,966
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • earnings479
  • therapy area

    no tagged catalysts yet

    Week of Feb 16, 2026

    8
    ›Feb 20, 2026device 510k169d 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 510k169d agoCara Medical, Ltd. — CARA System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 20, 2026device 510k169d 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 510k169d 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 510k169d 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 510k169d agoQstag, Inc. — QSCHECK UISACR (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 21, 2026device 510k168d 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 510k167d 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

    42
    ›Feb 23, 2026device 510k166d 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 91 of 100
    next →
    166d 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 510k166d 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 510k166d 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 510k166d 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 510k166d 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 510k166d 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 510k166d 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 510k166d 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 510k166d 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 510k166d 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 510k166d 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 510k166d 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 510k166d 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 510k166d 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 510k166d 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 510k165d 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 510k165d 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 510k165d 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 510k165d 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 510k165d 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 510k165d agoOsteomni, Inc. — OSTEOMNI SPINAL FIXATION SYSTEM (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 24, 2026device 510k165d 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 510k165d agoOSSIO , Ltd. — OSSIOfiber® Suture Anchor (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 24, 2026device 510k165d 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 510k165d 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 510k165d 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 510k165d 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 510k164d 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 510k164d 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 510k164d 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 510k164d 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 510k164d agoGrindguard, Inc. — Remi Impression Material (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 25, 2026device 510k164d 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 510k164d 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 510k163d 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 510k163d 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 510k163d agoORO Co., Ltd. — CAPRI (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 26, 2026device 510k163d agoOsteonic Co., Ltd. — Aster (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 26, 2026device 510k163d agoImplanet — SWINGO-3D Lumbar Cage System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 26, 2026device 510k163d 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 510k163d 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 ↗
    $ISRG376.21+0.67%
    $GMED79.93+1.27%
    $EW91.33-2.47%
    $ICCM0.2280+3.64%
    $BDX175.27-1.02%