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

LZG 2017-04-18

OmniPod Insulin Management System

Applicant Insulet Corporation

K-Number K162296

View Details →

DXN 2017-04-18

Finapres Nova Noninvasive Hemodynamic Monitor

Applicant Finapres Medical Systems B.V.

K-Number K160967

View Details →

LZU 2017-04-17

Soft Plug Extended Duration 180 Canalicular Plug

Applicant Oasis Medical, Inc.

K-Number K162361

View Details →

PMC 2017-04-17

Paxman Scalp Cooler

Applicant Paxman Coolers Limited

K-Number K163484

View Details →

FFX 2017-04-17

EndoFLIP® System with FLIP Topography module

Applicant Crospon, Ltd.

K-Number K170833

View Details →

IOR 2017-04-17

Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual Wheelchair

Applicant Invacare Corporation

K-Number K162621

View Details →

GWM 2017-04-17

Pressio 2 ICP Monitoring System

Applicant Sophysa SA

K-Number K162108

View Details →

PTD 2017-04-17

PowerFlow Apheresis I.V. Port

Applicant C.R. Bard, Inc.

K-Number K163001

View Details →

HJO 2017-04-14

Marco Ultra M3, Marco Ultra M4

Applicant Takagi Seiko Co., Ltd.

K-Number K162636

View Details →

OLO 2017-04-14

Navigated ELEVATE Inserter, Navigated Disc Prep Instruments

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K163581

View Details →

KTT 2017-04-14

Hoffmann LRF System

Applicant Stryker GmbH

K-Number K163656

View Details →

NKB 2017-04-14

Fortress™ Pedicular Fixation System

Applicant Spineology, Inc.

K-Number K170268

View Details →

Page 2422 of 2738

↑