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

KWL 2026-07-24

REMEDY POLY+PLUS SNAP FIT Acetabular Cup

Applicant Osteoremedies, LLC

K-Number K262290

View Details →

ITX 2026-07-24

Accuro® 3S Needle Guide Kit

Applicant Rivanna Medical, Inc.

K-Number K261014

View Details →

KDI 2026-07-24

Careflux H60;Careflux H70;Careflux V500

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K-Number K261267

View Details →

IYN 2026-07-23

ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/ MOZI-X1/ MOZI-X12/ DF-41E Diagnostic ultrasound system

Applicant Esonic Technology (Wuhan) Co., Ltd.

K-Number K261272

View Details →

KDN 2026-07-23

Perfadex Plus

Applicant Xvivo Perfusion AB

K-Number K261644

View Details →

DQD 2026-07-23

CORE 300 Digital Stethoscope

Applicant Eko Health, Inc.

K-Number K261694

View Details →

BZD 2026-07-23

RXiBreeze PAP System (RXiBreeze 20C)

Applicant Resvent Medical Technology Co., Ltd.

K-Number K253044

View Details →

SFF 2026-07-23

Total Flow Medical Femoral Arterial (TFA) cannula

Applicant Total Flow Medical Limited

K-Number K251576

View Details →

NFO 2026-07-23

FACEGYM Pro Device (HD-109)

Applicant Shenzhen Kaiyan Medical Equipment Co., Ltd.

K-Number K253932

View Details →

DXN 2026-07-23

Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)

Applicant Guangzhou Daxin Health Technology Co., Ltd.

K-Number K261136

View Details →

ODP 2026-07-23

3d Cage Cervical

Applicant Fims Co., Ltd.

K-Number K253041

View Details →

QIH 2026-07-23

VELMENI for DENTISTS (V4D) 3D

Applicant Velmeni, Inc.

K-Number K254096

View Details →

Page 68 of 14150

↑