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

MAX 2021-01-29

XYPAN Expandable Lumbar Cage System

Applicant Aegis Spine, Inc.

K-Number K203531

View Details →

BZE 2021-01-29

Sunset Heated CPAP Tube

Applicant Sunset Healthcare Solutions, Inc.

K-Number K201418

View Details →

EKX 2021-01-29

E-connect S Endo Motor with built-in Apex Locator

Applicant Changzhou Sifary Medical Technology Co., Ltd.

K-Number K201993

View Details →

ODP 2021-01-29

Ti3Z Cervical Interbody System

Applicant Zavation Medical Products, LLC

K-Number K202398

View Details →

NHA 2021-01-29

Neodent Implant System - Zirconia Implant System

Applicant Jjgc Industria E Comercio DE Materiais Dentarios S.A.

K-Number K202282

View Details →

KRA 2021-01-29

MAGIC Infusion Catheter

Applicant Balt USA, LLC

K-Number K202366

View Details →

HTY 2021-01-29

PediFlex Flexible Nail System

Applicant OrthoPediatrics Corp.

K-Number K201838

View Details →

QAU 2021-01-29

EndoClot

Applicant Endoclot Plus Co., Ltd.

K-Number K190677

View Details →

BTY 2021-01-28

MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU

Applicant Eresearchtechnology GmbH

K-Number K202754

View Details →

QJP 2021-01-28

BOSS 8F Balloon Guide Catheter

Applicant Marblehead Medical, LLC

K-Number K203840

View Details →

DWF 2021-01-28

Michler-Kapp Cardiovascular Vent Catheter

Applicant Kapp Surgical Instrument, Inc.

K-Number K200289

View Details →

MWI 2021-01-28

Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s

Applicant Edan Instruments, Inc.

K-Number K202892

View Details →

Page 1486 of 2744

↑