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

IYO 2016-04-08

Bladder Scanner

Applicant Caresono Technology Co., Ltd.

K-Number K153581

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GEI 2016-04-08

PERCUVANCE PERCUTANEOUS SURGICAL SYSTEM

Applicant Teleflexmedical, Inc.

K-Number K153063

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MEA 2016-04-08

LifeCare PCA Infusion System

Applicant Hospira, Inc.

K-Number K143612

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LLZ 2016-04-08

spineEOS

Applicant Onefit Medical

K-Number K160407

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NHC 2016-04-08

VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation, VentriClear II Ventricular Drainage Catheter

Applicant Cook Incorporated

K-Number K160223

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LLZ 2016-04-08

Xmaru View V1 and Xmaru PACS, Medical Image Processing Software

Applicant Rayence Co., Ltd.

K-Number K160579

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JDR 2016-04-08

First Ray Internal Bone Staple System

Applicant First Ray, LLC

K-Number K153622

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IPF 2016-04-08

geko(TM) Plus R-2 Neuromuscular Stimulator

Applicant Firstkind Limited

K-Number K160299

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JAK 2016-04-08

Philips Multislice CT System with Low Dose CT Lung Cancer

Applicant Philips Medical Systems (Cleveland), Inc.

K-Number K153444

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LPH 2016-04-08

ICONACY(TM) I-Hip(TM)

Applicant Iconacy Orthopedic Implants, LLC

K-Number K160266

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PGY 2016-04-07

CX20N(CX20PUX)

Applicant Wide Corporation

K-Number K160355

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KWY 2016-04-07

U2 Bipolar Implant and 22mm Femoral Head

Applicant United Orthopedic Corporation

K-Number K152439

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