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

DQA 2016-01-06

Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D

Applicant Guangdong Biolight Meditech Co., Ltd.

K-Number K151287

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PML 2016-01-06

KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set

Applicant Medtronic Sofamor Danek USA, Incorporated

K-Number K152604

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GAD 2016-01-06

OTELO LL

Applicant Spineart

K-Number K151104

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DXC 2016-01-06

VasoStat Hemostasis Device

Applicant Forge Medical, Inc.

K-Number K153259

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DPS 2016-01-06

Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems

Applicant Mortara Instrument, Inc.

K-Number K152944

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OAP 2016-01-06

iRestore

Applicant Freedom Laser Therapy, Inc.

K-Number K151662

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KNW 2016-01-05

K2M Fenestrated Tap System

Applicant K2m

K-Number K152872

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IOR 2016-01-05

MyOn HC Manual Wheelchair

Applicant Invacare Corporation

K-Number K152536

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DYB 2016-01-05

SoloPath Re-Collapsible Access System

Applicant Onset Medical Corporation

K-Number K152498

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NUH 2016-01-05

Quell

Applicant Neurometrix, Inc.

K-Number K152954

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OMP 2016-01-05

VENTURI MiNO TG600/14

Applicant Talley Group, Ltd.

K-Number K143004

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MPB 2016-01-05

Zenysis Short-Term Dialysis Catheter

Applicant C.R. Bard, Inc.

K-Number K153190

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