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

PAM 2026-08-06

QIAstat-Dx BCID GPF Plus AMR Panel

Applicant QIAGEN GmbH

K-Number K254194

View Details →

QNP 2026-08-05

CAD - Lower GI (EC07-01)

Applicant Xiamen Inno Medical Technology Co., Ltd.

K-Number K252853

View Details →

MMK 2026-08-05

Huahong Sharps Container (HHR-I, HHR-II)

Applicant Tianjin Huahong Technology Co., Ltd.

K-Number K260845

View Details →

KNY 2026-08-05

Transurethral Catheter Safety Valve (TUCSV) (80050)

Applicant Class Medical , Ltd.

K-Number K260919

View Details →

POW 2026-08-05

Ruthinium Disc

Applicant Dental Manufacturing S.p.A.

K-Number K261456

View Details →

N/A 2026-08-05

pVasc Net Mechanical Thrombectomy Device

Applicant Vesalio, Inc.

K-Number K254211

View Details →

HAW 2026-08-05

Leksell® Vantage Stereotactic System

Applicant Elekta Solutions AB

K-Number K261932

View Details →

OLR 2026-08-05

NaturaJel™ Oral Wound Care Kit

Applicant HCS Innovation, LLC

K-Number K260120

View Details →

EZD 2026-08-05

Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18).

Applicant Convatec

K-Number K260737

View Details →

EZL 2026-08-05

Rusch Latex Gold Foley Catheter

Applicant Teleflex Medical Sdn. Bhd.

K-Number K262056

View Details →

HWC 2026-08-05

GFS - Sterile Screws and Top Hat

Applicant T.A.G. Medical Products Corporation, Ltd.

K-Number K253858

View Details →

QKQ 2026-08-05

Concentriq AP-Dx

Applicant Proscia, Inc.

K-Number K261380

View Details →

Page 57 of 14150

↑