Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

FYA 2026-07-10

NYES Tuff Cuff L3 Disposable Gowns

Applicant New York Embroidery Studio

K-Number K261949

View Details →

PBX 2026-07-10

Capenergy C Equipments RF C200 and C400 Drakarian

Applicant Capenergy Medical S.L.

K-Number K253480

View Details →

ITI 2026-07-10

Electric Wheelchair (DY611A-2, DY612A-1)

Applicant Zhejiang Lumbre Electric Appliance Co., Ltd.

K-Number K261149

View Details →

NEW 2026-07-09

Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture

Applicant Teleflex Medical, LLC

K-Number K261988

View Details →

FOZ 2026-07-09

MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV Catheter

Applicant MedSource Labs, LLC

K-Number K260539

View Details →

QJI 2026-07-09

SmartGuard Technology; Predictive Low Glucose Technology

Applicant Medtronic MiniMed

K-Number K261962

View Details →

QFF 2026-07-09

Zeta TMS Navigation System

Applicant Zeta Surgical, Inc.

K-Number K261471

View Details →

DRG 2026-07-09

UbiqVue™ 2AYe Cardiac System (UX2253)

Applicant Lifesignals, Inc.

K-Number K261569

View Details →

EMA 2026-07-09

DIA-CEM

Applicant DiaDent Group International

K-Number K261166

View Details →

DSH 2026-07-09

LifeLens Physiological Monitor

Applicant LifeLens Technologies, Inc.

K-Number K260157

View Details →

PZP 2026-07-09

HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYDROS TRUS Probe (HU1000)

Applicant Procept Biorobotics

K-Number K260723

View Details →

LLZ 2026-07-09

3D-Anywhere

Applicant Provect.AI

K-Number K253899

View Details →

Page 82 of 14156

↑