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

HWC 2016-11-22

ToeTac™ 10° Hammertoe Fixation System

Applicant Restore Surgical, LLC Dba Instratek

K-Number K161778

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HRS 2016-11-22

LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ® VA Distal Fibula Plate 2.7/3.5

Applicant Aap Implantate AG

K-Number K161747

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PNR 2016-11-22

U&U Enteral Syringe

Applicant U&U Medical Technology Co, Ltd.

K-Number K160855

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MRZ 2016-11-22

WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System

Applicant Welldoc, Inc.

K-Number K162225

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OVD 2016-11-22

Leva® Anterior Interbody System

Applicant Spine Wave, Inc.

K-Number K161993

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DXT 2016-11-22

Disposable High Pressure Injector Syringe

Applicant Wuxi Yushou Medical Appliances Co., Ltd.

K-Number K152906

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LIT 2016-11-22

Pirouette 014

Applicant Arravasc, Ltd.

K-Number K162316

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KRA 2016-11-22

CXI Support Catheter

Applicant Cook Incorporated

K-Number K160884

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HIH 2016-11-22

Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device

Applicant Smith & Nephew, Inc.

K-Number K161763

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QEW 2016-11-22

FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction Aspirator

Applicant Inari Medical

K-Number K162970

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NKG 2016-11-22

Reform® POCT System

Applicant Precision Spine, Inc.

K-Number K162300

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DXN 2016-11-22

Evolv Model BP7000 Upper Arm Blood Pressure Monitor

Applicant Omron Healthcare, Inc.

K-Number K162092

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