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

FTL 2017-03-11

PROLENE Soft Polypropylene Mesh

Applicant ETHICON, Inc.

K-Number K163152

View Details →

OUR 2017-03-10

iFuse Implant System® - iFuse-3D implant

Applicant SI-BONE, Inc.

K-Number K162733

View Details →

DQK 2017-03-10

RHYTHMIA HDx Mapping System

Applicant Boston Scientific Corporation

K-Number K162793

View Details →

FLL 2017-03-10

Infrared Non-contact Thermometer, Model ACT8100

Applicant Easywell Biomedicals, Inc.

K-Number K162509

View Details →

FOZ 2017-03-10

BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless Connector

Applicant Becton, Dickinson and Company

K-Number K170336

View Details →

OBP 2017-03-10

Rapid2 Therapy System

Applicant Magstim Company, Ltd.

K-Number K162935

View Details →

DXO 2017-03-10

Mikro-Cath Pressure Catheter

Applicant Millar, Inc.

K-Number K163376

View Details →

MAX 2017-03-10

Altus Spine Titanium Interbody Fusion System

Applicant Altus Partners, LLC

K-Number K170512

View Details →

NAY 2017-03-10

EndoWrist Stapler 45 Instrument, EndoWrist Stapler 45 Reloads, EndoWrist Stapler 30 Instrument, EndoWrist Stapler 30 Reloads

Applicant Intuitive Surgical, Inc.

K-Number K170508

View Details →

JJY 2017-03-10

Audit MicroControls Linearity FD Tumor Markers II

Applicant Aalto Scientific, Ltd.

K-Number K163629

View Details →

GCJ 2017-03-10

InterLock Trocar

Applicant Fujifilm New Development U.S.A., Inc.

K-Number K170084

View Details →

DQD 2017-03-10

Adscope 658 Electronic Stethoscope

Applicant American Diagnostic Corp.

K-Number K162589

View Details →

Page 2391 of 2685

↑