Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

KCT 2016-01-25

Ellipse Supplemental Instrument Trays

Applicant Ellipse Technologies, Incorporated

K-Number K151594

View Details →

LLZ 2016-01-25

Fusion Bx

Applicant Focal Healtcare, Inc.

K-Number K153166

View Details →

KPS 2016-01-25

ImagenSPECT

Applicant Cardiovascular Imaging Technologies

K-Number K152503

View Details →

DQX 2016-01-22

PW Guidewires

Applicant Tatara Vascular, LLC

K-Number K152497

View Details →

DQY 2016-01-22

ASAHI Caravel

Applicant Asahi Intecc Co., Ltd.

K-Number K152447

View Details →

OMP 2016-01-22

Mepiseal Soft Silicone Sealant

Applicant Molnlycke Health Care Us, LLC

K-Number K152741

View Details →

OQU 2016-01-22

SonarMed AirWave, Airway Monitoring System

Applicant Sonarmed, Inc.

K-Number K143042

View Details →

HCG 2016-01-22

MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)

Applicant MicroVention, Inc.

K-Number K153594

View Details →

MAH 2016-01-22

Ponto Bone Anchored Hearing System

Applicant Oticon Medical AB

K-Number K152820

View Details →

NLH 2016-01-22

Livewire Electrophysiology Catheter

Applicant Surgical Instrument Service and Savings Inc.(Dba Medline Ren

K-Number K151617

View Details →

GWM 2016-01-22

DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables

Applicant Medos International SARL

K-Number K152670

View Details →

EIA 2016-01-22

TAURUS C1

Applicant Shinhung Company, Ltd.

K-Number K151996

View Details →

Page 2748 of 2763

↑