Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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

MUJ 2025-04-11

Oncospace

Applicant Oncospace, Inc.

K-Number K242748

View Details →

FET 2025-04-11

FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R

Applicant Fujifilm Corporation

K-Number K243260

View Details →

NDN 2025-04-11

XeliteMed VertehighFix High Viscosity Spinal Bone Cement System

Applicant Xelite Biomed , Ltd.

K-Number K243537

View Details →

QIH 2025-04-11

GBrain MRI

Applicant Galileo Cds, Inc.

K-Number K250416

View Details →

EBW 2025-04-11

Dental Implant Unit

Applicant Guilin Aesthedent Medical Instruments Co., Ltd.

K-Number K242646

View Details →

HIF 2025-04-11

AirSurgN Insufflator (10030/AirSurgN)

Applicant SmartsurgN, Inc.

K-Number K242772

View Details →

JDR 2025-04-11

Medline UNITE® REFLEX® Hybrid Nitinol Implant System

Applicant Medline Industries, LP

K-Number K243888

View Details →

MSY 2025-04-11

Chlorine Sentinel II

Applicant Nelson Environmental Technologies, Inc.

K-Number K243898

View Details →

QWR 2025-04-11

cobas liat SARS-CoV-2 v2 nucleic acid test

Applicant Roche Molecular Systems, Inc.

K-Number K243346

View Details →

EIH 2025-04-11

Dental Zirconia Ceramic

Applicant Aidite (Qinhuangdao) Technology Co., Ltd.

K-Number K250811

View Details →

HHW 2025-04-11

CooperSurgical Milex® Pessaries

Applicant CooperSurgical, Inc.

K-Number K250438

View Details →

ITI 2025-04-11

KLAXON (TWIST); KLAXON (TWIST R)

Applicant Klaxon-Mobility GmbH

K-Number K250748

View Details →

Page 299 of 2685

↑