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

FCG 2016-03-21

Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle

Applicant Cook Ireland, Ltd.

K-Number K160229

View Details →

LRK 2016-03-21

Oniris

Applicant Sas Oniris

K-Number K150566

View Details →

MPO 2016-03-18

Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418)

Applicant CooperSurgical, Inc.

K-Number K151845

View Details →

GEI 2016-03-18

SPINAUT-P

Applicant Imedicom Co., Ltd.

K-Number K150915

View Details →

LAF 2016-03-18

Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators

Applicant Immunalysis Corporation

K-Number K153693

View Details →

JAK 2016-03-18

somatom Scope(with syngo CT VC30-easyIQ version), SOMATOM Scope Power(with syngo CT VC30-easyIQ version)

Applicant Siemens Medical Solutions USA, Inc.

K-Number K151749

View Details →

ONX 2016-03-18

OVA1 Next Generation

Applicant Vermillion, Inc.

K-Number K150588

View Details →

MQB 2016-03-18

Tuxedo Digital Dental Sensor

Applicant Led Dental, Inc.

K-Number K153710

View Details →

DXN 2016-03-18

CareTaker Continuous Non-Invasive Blood Pressure Monitor, CareTaker Wireless VItal Signs Monitor

Applicant Caretaker Medical, LLC

K-Number K151499

View Details →

LDJ 2016-03-18

CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test

Applicant Hangzhou Clongene Biotech Co., Ltd.

K-Number K153741

View Details →

DXX 2016-03-18

CorPath 200 System

Applicant Corindus, Inc.

K-Number K152999

View Details →

MNR 2016-03-18

AUDICOR CA300/CC100 Analyzer with SDB

Applicant Inovise Medical, Inc.

K-Number K151433

View Details →

Page 2632 of 2685

↑