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

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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OMP 2016-01-05

FloSure Ventilation Patch

Applicant Simex Medizintechnik GmbH

K-Number K150459

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JXM 2016-01-05

Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators

Applicant Immunalysis Corporation

K-Number K151771

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GEI 2016-01-05

New Deantronics Disposable Laparoscopic Electrodes, non-coated, and coated

Applicant New Deantronics Taiwan , Ltd.

K-Number K153265

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GEI 2016-01-04

InMode FRF Applicator

Applicant Inmode MD , Ltd.

K-Number K151273

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