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

DYB 2025-04-30

AuST Steerable Sheath

Applicant CenterPoint Systems, LLC

K-Number K251051

View Details →

OWB 2025-04-30

Persona C HR

Applicant A.T.S. Applicazione Tecnologie Speciali S.R.L.

K-Number K250282

View Details →

NRY 2025-04-30

APRO 45 Catheter and Alembic Aspiration Tubing

Applicant Alembic, LLC

K-Number K251015

View Details →

BTR 2025-04-29

LMA Fastrach ETT SU

Applicant Teleflex Medical

K-Number K242495

View Details →

HRS 2025-04-29

Pediatric Plating Platform Hip

Applicant OrthoPediatrics Corp.

K-Number K243963

View Details →

KGC 2025-04-29

PUMA-G Pediatric System

Applicant Coaptech, Inc.

K-Number K242211

View Details →

KNW 2025-04-29

ExpressCore Biopsy Device

Applicant Inrad, Inc.

K-Number K243886

View Details →

FMG 2025-04-29

Qitexio® 4-Way Stopcock (QIT014)

Applicant Medex

K-Number K242255

View Details →

CAF 2025-04-29

AllNEB

Applicant Enchant Tek Co. , Ltd.

K-Number K242354

View Details →

EBI 2025-04-29

Apex Flex

Applicant Sprintray, Inc.

K-Number K250617

View Details →

OAP 2025-04-29

Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S, KCA441-120S, KCA441-88S, KCA441-56S, KCA451-200, KCA451-120, KCA451-88, KCA451-56, KCA451-200S, KCA451-120S, KCA451-88S, KCA451-56S)

Applicant Dongguan Boyuan Intelligent Technology Co.,Ltd

K-Number K250308

View Details →

DQY 2025-04-29

APRO 55 Intermediate Catheter

Applicant Alembic, LLC

K-Number K250962

View Details →

Page 287 of 2685

↑