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

MAX 2019-03-01

IdentiTi Porous Ti Interbody System

Applicant Alphatec Spine, Inc.

K-Number K183705

View Details →

PNP 2019-03-01

DTX Studio design

Applicant Nobel Biocare AB

K-Number K181932

View Details →

JOJ 2019-03-01

Lead-free Chemical Indicators for Steam Sterilization

Applicant Kem Medical Products Corp.

K-Number K181788

View Details →

GEX 2019-03-01

Vydence Laser Family

Applicant Vydence Medical Industria E Comercio Ltda

K-Number K190007

View Details →

KNT 2019-03-01

Traditional Length GJ Feeding Device

Applicant Applied Medical Technology, Inc.

K-Number K182804

View Details →

MNR 2019-03-01

XactTrace Single Use Respiratory Effort Belt System

Applicant Embla Systems

K-Number K173793

View Details →

GKZ 2019-03-01

DxH 520 Hematology Instrument

Applicant Beckman Coulter

K-Number K181475

View Details →

MVM 2019-03-01

EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay

Applicant Phadia AB

K-Number K181871

View Details →

MBI 2019-03-01

Tenodesis Screw System

Applicant Paragon 28, Inc.

K-Number K183690

View Details →

DQK 2019-03-01

EP-TRACER System

Applicant Schwarzer Cardiotek GmbH

K-Number K183266

View Details →

IOR 2019-03-01

Manual Wheelchair

Applicant Jiangyin Newrise Medical Equipment Co., Ltd.

K-Number K180852

View Details →

QFJ 2019-03-01

Early Bird Bleed Monitoring System

Applicant Saranas, Inc.

K-Number DEN180021

View Details →

Page 1881 of 2685

↑