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

HRS 2026-06-02

Pectus Blu System

Applicant Biomet Microfixation

K-Number K261002

View Details →

GEI 2026-06-02

MILAN System

Applicant Lumenis Be, Ltd.

K-Number K253803

View Details →

QAU 2026-06-02

Hemospray Endoscopic Hemostat (HEMO-[X])

Applicant Wilson-Cook Medical, Inc.

K-Number K253302

View Details →

NKG 2026-06-02

TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems

Applicant ZheJiang Decans Medical Devices Co., Ltd.

K-Number K253195

View Details →

IOR 2026-06-02

Manual Wheelchair (LW01108)

Applicant Anhui Longway Medical Technology Co., Ltd.

K-Number K260642

View Details →

PHZ 2026-06-02

Tyto Insights for Wheeze Detection (with PCCP)

Applicant Tyto Care , Ltd.

K-Number K252844

View Details →

MQV 2026-06-02

Device 300419 Strip

Applicant Geistlich Pharma AG

K-Number K260364

View Details →

KDN 2026-06-01

VI°Port™ Liver Preservation System

Applicant Traferox Technologies, Inc.

K-Number K260456

View Details →

NWA 2026-06-01

VisionAir Enhanced Stock Stent

Applicant VisionAir Solutions

K-Number K261541

View Details →

QVF 2026-06-01

CorDx Tyfast COVID-19 Ag Rapid Test Rx

Applicant CorDx, Inc.

K-Number K253882

View Details →

HWC 2026-05-30

CoLink® & CoLag® Non-Sterile Screws

Applicant In2Bones USA, LLC

K-Number K261154

View Details →

FCM 2026-05-29

BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit

Applicant C.R. Bard, Inc.

K-Number K254076

View Details →

Page 114 of 14156

↑