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

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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DQK 2016-04-07

Merge Hemo

Applicant Merge Healthcare Incorporated

K-Number K152864

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PMU 2016-04-07

PneumoLiner

Applicant Advanced Surgical Concepts, Ltd.

K-Number DEN150028

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PGY 2016-04-07

CX50N, CX50YQS

Applicant Wide Corporation

K-Number K160351

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GZI 2016-04-07

ReGrasp

Applicant Rehabtronics, Inc.

K-Number K153163

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MTD 2016-04-07

FIRMap Catheter

Applicant Abbott Electrophysiology

K-Number K153093

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IYN 2016-04-07

SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner

Applicant Beijing East Whale Imaging Technology Co., Ltd.

K-Number K160343

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JXG 2016-04-07

StrataMR Valves and Shunts

Applicant Medtronic Neurosurgery

K-Number K152700

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