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

ODP 2016-07-15

Ascential IBD PEEKc Spacer

Applicant Stryker Spine

K-Number K161407

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OVD 2016-07-15

TransContinental® M Spacers and InterContinental® Plate-Spacers

Applicant Globus Medical, Inc.

K-Number K161223

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NKB 2016-07-15

Threshold™ Pedicular Fixation System

Applicant Spineology, Inc.

K-Number K161694

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KWQ 2016-07-15

Belvedere™ Lateral Plating System

Applicant Neurostructures, Inc.

K-Number K153097

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FLL 2016-07-15

Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT)

Applicant Fudakang Industrial Co., Ltd.

K-Number K160308

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MSH 2016-07-15

N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12

Applicant San-M Package Co., Ltd.

K-Number K160271

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MAX 2016-07-15

Keos Lumbar IBFD

Applicant Keos

K-Number K160631

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JWH 2016-07-15

ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)

Applicant Conformis, Inc.

K-Number K161668

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EBF 2016-07-15

CAD/CAMouflage Milling Bock

Applicant Prismatik Dentalcraft, Inc.

K-Number K160425

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DQY 2016-07-14

Wingman 18 Crossing Catheter

Applicant Reflow Medical, Inc.

K-Number K160848

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GZL 2016-07-14

PMT Platinum Depthalon Depth Electrode

Applicant Pmt Corporation

K-Number K151790

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EIH 2016-07-14

Amber Mill Series and Amber Press Series

Applicant Hass Corp.

K-Number K160102

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