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5,000 catalysts · 18,987 approval · 5,811 phase readout · 5,000 device 510k · 4,728 grant · 2,984 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: 0 catalysts2026-08-08: 0 catalysts2026-08-09: 0 catalysts2026-08-10: 14 catalysts2026-08-11: 16 catalysts2026-08-12: 19 catalysts2026-08-13: 19 catalysts2026-08-14: 4 catalysts2026-08-15: 0 catalysts2026-08-16: 0 catalysts2026-08-17: 1 catalyst2026-08-18: 2 catalysts2026-08-19: 2 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: 11 catalysts2026-10-29: 20 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 filing2,984
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • earnings571
  • therapy area

    no tagged catalysts yet

    Week of Mar 9, 2026

    10
    ›Mar 13, 2026device 510k149d agoShenzhen Kingboom Technology Co., Ltd. — Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Mar 13, 2026device 510k149d agoWeero Co., Ltd. — Apollo Quattro (APQ-10M) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 13, 2026device 510k149d agoPegavision Corporation — Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses (510k cleared)

    Product code: LPL. Advisory committee: Ophthalmic. Type: Traditional

    full page →fda device 510k ↗
    ›Mar 13, 2026device 510k149d agoBoston Scientific Corporation — TheraSphere 360™ Y-90 Management Platform (510k cleared)BOSTON SCIENTIFIC CORP

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

    full page →fda device 510k ↗
    ›Mar 13, 2026device 510k149d agoZeto, Inc. — New Wave System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 13, 2026device 510k149d agoTaewoong Medical Co., Ltd. — Niti-S SPAXUS Stent (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 13, 2026device 510k149d agoPressure Products Medical Device Manufacturing, LLC — SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 13, 2026device 510k149d agoSolventum Germany GmbH — Promogran Prisma™ Collagen Matrix with ORC and Silver (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 13, 2026device 510k149d agoGenbody.Inc. — GenBody COVID-19 Ag Home Test (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 15, 2026device 510k147d agoTechnomed Europe — Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable Concentric Needle Electrode 0.40x25mm Yellow (TE/B50700-002); Disposable Concentric Needle Electrode 0.30x30mm Pink (TE/B50700-006); Disposable Concentric Needle Electrode 0.45x37mm Green (TE/B50700-003); Disposable Concentric Needle Electrode 0.45x50mm Blue (TE/B50700-004); Disposable Concentric Needle Electrode 0.60x75mm Violet (TE/B50700-005) (510k cleared)

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

    full page →fda device 510k ↗

    Week of Mar 16, 2026

    40
    ›Mar 16, 2026device 510k146d agoOrthocon, Inc. — Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 16, 2026device 510k
    ← prev
    page 95 of 100
    next →
    146d ago
    Shanghai Achieva Medical Suzhou Co., Ltd. — DCwire Micro-guidewire (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 16, 2026device 510k146d agoLifemotion Medical Technology Co., Ltd. — Lifemotion Disposable Membrane Oxygenator (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Mar 16, 2026device 510k146d agoIzenimplant Co., Ltd. — ZENEX Implant System_Short (R-System) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 16, 2026device 510k146d agoMedartis AG — APTUS Shoulder Proximal Humerus System, PentaLock 3.5 (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 16, 2026device 510k146d agoCarboFix Orthopedics , Ltd. — CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 16, 2026device 510k146d agoMedtronic Navigation, Inc. — Stealth AXiS™ ENT clinical application (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 16, 2026device 510k146d agoStryker Instruments — SurgiCount+ System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 16, 2026device 510k146d agoSonio — Sonio Detect (v3) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 16, 2026device 510k146d agoHealgen Scientific,, LLC — Healgen® Accurate Oral Fluid Drug Test (510k cleared)

    Product code: DJC. Advisory committee: Clinical Toxicology. Type: Traditional

    full page →fda device 510k ↗
    ›Mar 16, 2026device 510k146d agoPerfuze, Ltd. — Millipede System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 16, 2026device 510k146d agoBAAT Medical Products B.V. — SINEFIX (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 16, 2026device 510k146d agoVoronoi Health Analytics Incorporated — Data Analysis Facilitation Suite (DAFS) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 16, 2026device 510k146d agoShenzhen Desida Technology Co., Ltd. — LED Light Therapy Mask (Models: T2, RLD10) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Mar 16, 2026device 510k146d agoShenzhen Ulike Smart Electronics Co., Ltd. — Ulike Reglow Light Therapy Device (UM10) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 17, 2026device 510k145d agoEncore Guards — enCore Impression Material (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 17, 2026device 510k145d agoTyto Care , Ltd. — Tyto Insights for Eardrum Bulging Detection (510k cleared)

    Product code: SHL. Advisory committee: Ear, Nose, Throat. Type: Direct

    full page →fda device 510k ↗
    ›Mar 17, 2026device 510k145d agoCompal Electronics, Inc. — BreathePal Bilevel (GFM50-MD2201) (510k cleared)ARROW ELECTRONICS, INC.

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

    full page →fda device 510k ↗
    ›Mar 17, 2026device 510k145d agoStreck, LLC — MDx-Chex for BCY (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 17, 2026device 510k145d agoElesta S.P.A — LASER THERMAL THERAPY KIT (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 17, 2026device 510k145d agoBTL Industries, Inc. — BTL-785NEH (510k cleared)NL INDUSTRIES INC

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

    full page →fda device 510k ↗
    ›Mar 17, 2026device 510k145d agoA Plus Biotechnology Co., Ltd. — APS Spear Locking Plate (510k cleared)Avistone Biotechnology Co Ltd

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

    full page →fda device 510k ↗
    ›Mar 17, 2026device 510k145d agoGM Dos Reis Industria e Comercio Ltda. — Super Upper Limbs Versalock Plating System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 17, 2026device 510k145d agoParagon 28, Inc. — Grappler Suture Anchor PCFD Tether System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 17, 2026device 510k145d agoLerado Zhongshan Peaceful Cove Business Trading Co., Ltd. — Electrical Scooter (SM4226) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 17, 2026device 510k145d agoSerim Research — GUARDIAN™ Quick Dip Residual Chlorine (5212) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 17, 2026device 510k145d agoC.R. Bard, Inc. — Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 17, 2026device 510k145d agoPhilips Medical Systems Nederland B.V. — EchoNavigator R5.0 (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 17, 2026device 510k145d agoCala Health, Inc. — Cala kIQ Plus (510k cleared)CARDINAL HEALTH INC

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

    full page →fda device 510k ↗
    ›Mar 17, 2026device 510k145d agoK2m, Inc. — Q Pedicle Instruments (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 18, 2026device 510k144d agoLimFlow, Inc. — LimFlow Vector (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 18, 2026device 510k144d agoVarian Medical Systems, Inc. — syngo.via RT Image Suite VC10 (510k cleared)MERIT MEDICAL SYSTEMS INC

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

    full page →fda device 510k ↗
    ›Mar 18, 2026device 510k144d agoO&M Halyard, Inc. — HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround Visor (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 18, 2026device 510k144d agoMedShape, Inc. — DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 18, 2026device 510k144d agoVision Rt, Ltd. — AlignRT Plus (8.0) (510k cleared)Rail Vision Ltd.

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

    full page →fda device 510k ↗
    ›Mar 18, 2026device 510k144d agoFusion Orthopedics USA, LLC — Fusion FibFix Nail (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 18, 2026device 510k144d agoMiRus, LLC — EUROPA™ Posterior Cervical Fusion Navigated Instruments (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 18, 2026device 510k144d agoNingbo Medsun Medical Co., Ltd. — Safety Pen Needle (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 18, 2026device 510k144d agoSangi Co., Ltd. — APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste) (510k cleared)SanBio Co Ltd

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

    full page →fda device 510k ↗
    ›Mar 18, 2026device 510k144d agoCarl Zeiss Vision GmbH — VISUREF 600 (510k cleared)

    Product code: HJO. Advisory committee: Ophthalmic. Type: Traditional

    full page →fda device 510k ↗
    $FRTRY
    $BSX49.31+0.02%
    $NL6.0500-1.14%
    $ARW226.78+1.76%
    $FRTRY
    $RVSN4.4000-4.56%
    $CAH236.40-0.53%
    $MMSI89.04+1.54%