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

PIF 2016-04-05

NUTRICARE-ISOSAF NASO-GASTRIC FEEDING TUBE

Applicant Gbuk Enteral Limited

K-Number K151503

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EMA 2016-04-05

PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement

Applicant Gaia Dental Products, Inc.

K-Number K152652

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GEI 2016-04-05

Non-Telescopic PenEvac

Applicant I.C Medical, Inc.

K-Number K160160

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BZD 2016-04-05

SleepWeaver Advance Pediatric Nasal CPAP Mask

Applicant Circadiance, LLC

K-Number K151683

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JOW 2016-04-04

Hydroven 12, Hydroven 12 Garments

Applicant Huntleigh Healthcare , Ltd.

K-Number K152228

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MEB 2016-04-04

SMARTez elastomeric infusion pump

Applicant Epic Medical Pte. , Ltd.

K-Number K151650

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MAX 2016-04-04

Opticage(R) Expandable Interbody Fusion Device

Applicant Interventional Spine, Inc.

K-Number K160464

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IYN 2016-04-04

Acclarix LX8 Diagnostic Ultrasound System

Applicant Edan Instruments, Inc.

K-Number K160790

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HSB 2016-04-04

PRECICE Intramedullary Limb Lengthening System

Applicant Ellipse Technologies, Inc.

K-Number K160325

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LZA 2016-04-04

HG Pro Nitrile Powder Free Examination Gloves

Applicant Healthy Glove Co., Ltd.

K-Number K152479

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MNI 2016-04-04

LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System

Applicant Spinevision S.A.

K-Number K160124

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NGT 2016-04-04

0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe

Applicant Becton, Dickinson and Company

K-Number K153481

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