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

DTZ 2016-02-26

TandemLung Oxygenator

Applicant Cardiacassist, Inc.

K-Number K153295

View Details →

FRC 2016-02-26

BCR-30-min BI and RBIP-ST30 Readout Accessory

Applicant Bcr Diagnostics, Inc.

K-Number K151482

View Details →

DXK 2016-02-26

Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)

Applicant Boston Scientific Corporation

K-Number K160173

View Details →

MQB 2016-02-26

VIVIX-S 1717N

Applicant Vieworks Co., Ltd.

K-Number K152894

View Details →

PMV 2016-02-26

Beactive Brace

Applicant Natures Pillows, Inc.

K-Number K151476

View Details →

MQB 2016-02-26

VIVIX-S 1012N

Applicant Vieworks Co., Ltd.

K-Number K152855

View Details →

DTK 2016-02-26

VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM

Applicant B. Braun Interventional Systems, Inc.

K-Number K152765

View Details →

MWJ 2016-02-26

H3+ Holter Recorder

Applicant Mortara Instrument, Inc.

K-Number K152626

View Details →

MNI 2016-02-26

Sniper (R) Spine System

Applicant Spine Wave, Inc.

K-Number K160003

View Details →

EWY 2016-02-26

Illuminated Mediastinal Access Port

Applicant Aegis Surgical, Ltd.

K-Number K160171

View Details →

IYN 2016-02-26

E-CUBE i7

Applicant Alpinion Medical Systems Co., Ltd.

K-Number K153424

View Details →

EBF 2016-02-26

Calcium Bridge

Applicant Denali Corporation

K-Number K153191

View Details →

Page 2648 of 2685

↑