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

OMP 2016-11-04

Avance Foam Dressing Kit - XL

Applicant Molnlycke Health Care Us, LLC

K-Number K161935

View Details →

ORZ 2016-11-04

LipiFlow Thermal Pulsation System

Applicant Tearscience, Inc.

K-Number K161357

View Details →

LIT 2016-11-04

Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Express SD Biliary Monorail Premounted Stent System, Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter, Sterling Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Ultra-Soft SV Monorail Balloon Dilatation Catheter 0.018

Applicant Boston Scientific Corporation

K-Number K162350

View Details →

DYB 2016-11-04

Pinpoint GT Introducer Needle

Applicant C.R. Bard, Inc.

K-Number K162769

View Details →

CHL 2016-11-04

ABL90 FLEX PLUS

Applicant Radiometer Medical Aps

K-Number K160153

View Details →

MUH 2016-11-04

SuniIQ Digital Radiography System

Applicant Suni Medical Imaging, Inc.

K-Number K162585

View Details →

HRS 2016-11-04

AOS Small Fragment Plating System

Applicant Advanced Orthopaedic Solutions, Inc. (Aos)

K-Number K161913

View Details →

NHA 2016-11-04

Inclusive Abutments

Applicant Prismatik Dentalcraft, Inc.

K-Number K160979

View Details →

KPS 2016-11-04

D-SPECT Scanner, D-SPECT L Scanner

Applicant Spectrum Dynamics Medical, Ltd.

K-Number K161740

View Details →

GWQ 2016-11-04

Trex_HD

Applicant Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)

K-Number K162595

View Details →

HRS 2016-11-04

LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer

Applicant Aap Implantate AG

K-Number K161703

View Details →

FRG 2016-11-04

Barrier Supreme Sterilization Wrapper

Applicant Standard Textile Co., Inc.

K-Number K162162

View Details →

Page 2477 of 2685

↑