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

HTY 2025-06-11

Impact PEEK Union Nail System

Applicant Nvision Biomedical Technologies

K-Number K250646

View Details →

SAH 2025-06-11

Self-Forming Magnet (Flexagon)

Applicant GI Windows, Inc.

K-Number K243482

View Details →

FAJ 2025-06-11

Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection)

Applicant Ambu A/S

K-Number K250269

View Details →

HQC 2025-06-11

MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)

Applicant Carl Zeiss Meditec Cataract Technology, Inc.

K-Number K242801

View Details →

KIF 2025-06-11

Injectable Root Canal Bioceramic Sealer (nRoot SP)

Applicant Enpuno Co., Ltd.

K-Number K250710

View Details →

NAY 2025-06-11

da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000)

Applicant Intuitive Surgical, Inc.

K-Number K240852

View Details →

BTO 2025-06-10

5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm; 5310600-5311000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, Fenestrated, sizes 6.0-10.0mm; 5400600-5401000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, sizes 6.0-10.0mm; 5410500-5411000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, Fenestrated, sizes 6.0-10.0mm

Applicant Vitaltec Corporation

K-Number K242921

View Details →

GEI 2025-06-10

EndyMed PRO MAX

Applicant Endymed Medical, Ltd.

K-Number K242996

View Details →

OWB 2025-06-10

EXTRON 3; EXTRON 5; EXTRON 7

Applicant DRTECH Corporation

K-Number K250010

View Details →

PEM 2025-06-10

Dental Barrier and Sleeves

Applicant Fomed Industries, Inc.

K-Number K250735

View Details →

FDS 2025-06-10

FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP

Applicant Fujifilm Corporation

K-Number K243512

View Details →

CCK 2025-06-10

TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)

Applicant Nihon Kohden Corporation

K-Number K243956

View Details →

Page 376 of 14156

↑