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

HET 2025-04-25

i-Cut

Applicant A.M.I. Agency For Medical Innovations GmbH

K-Number K243821

View Details →

FRN 2025-04-25

BD Alaris Infusion System with Guardrails Suite MX

Applicant Carefusion 303, Inc.

K-Number K243855

View Details →

MCW 2025-04-25

FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)

Applicant Cardio Flow Inc.,

K-Number K250723

View Details →

JAQ 2025-04-25

Intracavitary/Interstitial System

Applicant Varian Medical Systems

K-Number K250289

View Details →

JOJ 2025-04-25

VERIFY STEAM Integrating Indicator

Applicant STERIS Corporation

K-Number K243876

View Details →

BTM 2025-04-25

butterflyBVM

Applicant Compact Medical, Inc.

K-Number K243861

View Details →

DYB 2025-04-25

Prelude Wave Hydrophilic Sheath Introducer

Applicant Merit Medical Systems, Inc.

K-Number K250909

View Details →

JLW 2025-04-25

Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)

Applicant Siemens Healthcare Diagnostics

K-Number K243570

View Details →

GYD 2025-04-25

Neu Platform

Applicant Neuhealth Digital , Ltd.

K-Number K250153

View Details →

QLQ 2025-04-25

prodisc® L Instruments

Applicant Centinel Spine, LLC

K-Number K250554

View Details →

IRP 2025-04-25

Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617)

Applicant Shenzhen Urion Technology Co., Ltd.

K-Number K250046

View Details →

QPB 2025-04-25

PAL 7020 Console

Applicant Microaire Surgical Instruments, LLC

K-Number K244026

View Details →

Page 368 of 2738

↑