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

PCA 2020-02-21

Applied Biosystems 3500 Dx Genetic Analyzer and Applied Biosystems 3500xL Dx Genetic Analyzer

Applicant Life Technologies Corporation

K-Number K191030

View Details →

GXD 2020-02-21

Coolief Radiofrequency Generator (CRG) System

Applicant Avanos Medical, Inc.

K-Number K192491

View Details →

FRO 2020-02-21

Biatain Silicone Ag

Applicant Coloplast A/S

K-Number K191536

View Details →

FED 2020-02-21

PatCom Single-Use Introducer

Applicant H&A Mui Enterprises, Inc.

K-Number K192691

View Details →

PHX 2020-02-21

Glenoid Baseplate with Screw

Applicant Fx Shoulder USA, Inc.

K-Number K192799

View Details →

PGY 2020-02-21

3MP Monochrome Digital Mammography LCD Monitor MS-S300

Applicant Jvckenwood Corporation

K-Number K200161

View Details →

MAX 2020-02-21

Omnia Medical TiBrid Cervical Cage, Omnia Medical TiBrid Lateral Cage, Omnia Medical TiBrid ALIF Cage, Omnia Medical TiBrid PLIF Cage, Omnia Medical TiBrid TLIF Cage

Applicant Omnia Medical, LLC

K-Number K190363

View Details →

OHP 2020-02-21

ULTepap Expiratory Positive Airway Pressure (EPAP) Device

Applicant Bryggs Medical, LLC

K-Number K191728

View Details →

NHA 2020-02-21

UCLA CCM Abutment

Applicant Dio Corporation

K-Number K192263

View Details →

QJY 2020-02-21

Unity Subcutaneous Infusion System for Remodulin

Applicant DEKA Research & Development

K-Number K191313

View Details →

NQQ 2020-02-20

Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter

Applicant Gentuity, LLC

K-Number K192922

View Details →

PHX 2020-02-20

Exactech® Equinoxe® Reverse Shoulder Glenospheres

Applicant Exactech, Inc.

K-Number K193098

View Details →

Page 1642 of 2685

↑