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

FPA 2025-12-04

nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]

Applicant Np Medical

K-Number K251257

View Details →

MBI 2025-12-04

Tigon Medical Knotless and Dual Javelin All-Suture Anchors

Applicant Tigon Medical

K-Number K252596

View Details →

JNL 2025-12-04

ADVIA Centaur Anti-Thyroglobulin II (aTgII)

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K250816

View Details →

OEB 2025-12-03

AVIEW Lung Nodule CAD

Applicant Coreline Soft Co., Ltd.

K-Number K251203

View Details →

FYA 2025-12-03

Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL)

Applicant Yadu Medical (Henan) Co., Ltd.

K-Number K250564

View Details →

DSH 2025-12-03

VitaloJAK Clinic (Model 7100)

Applicant Vitalograph , Ltd.

K-Number K253293

View Details →

SCV 2025-12-03

Hugo™ RAS System

Applicant Covidien, LLC

K-Number K250725

View Details →

OLT 2025-12-03

HippoMind (v1.0)

Applicant Hippoclinic

K-Number K251881

View Details →

IYN 2025-12-03

Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/Fibrous 5 Diagnostic UltrasoundSystem

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K251601

View Details →

QJI 2025-12-03

Omnipod 5 algorithm

Applicant Insulet Corporation

K-Number K251779

View Details →

QJP 2025-12-03

Bendit17 Microcatheter

Applicant Bend IT Technologies, Ltd.

K-Number K252213

View Details →

JAD 2025-12-03

GentleBeam (GB1000)

Applicant Voxel Ray Solutions, LLC

K-Number K250692

View Details →

Page 195 of 2728

↑