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

IYE 2016-11-01

Z-Box/Z-Tilt Breast and Thoracic Positioning Device, Z-Square Indexing System, Z-Foam, Z-Bar Index Bar, Z-Pulls Patient Hand Grip Overlay

Applicant Zdi, Solutions, LLC

K-Number K162002

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HRX 2016-11-01

AVAmax Vertebral Balloon, AVAflex Vertebral Balloon

Applicant Stryker Corporation

K-Number K162062

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NDN 2016-11-01

13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex)

Applicant Pan Medical , Ltd.

K-Number K162453

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HSD 2016-11-01

Anatomical Shoulder Domelock Dome centric

Applicant Zimmer GmbH

K-Number K161620

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MAX 2016-11-01

T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System

Applicant Synthes USA Products, LLC

K-Number K162358

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JXI 2016-10-31

AxoGuard Nerve Connector

Applicant Cook Biotech Incorporated

K-Number K162741

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LCJ 2016-10-31

Unger Quad Injector

Applicant Stradis Healthcare

K-Number K161483

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MSQ 2016-10-31

BreathID Hp Lab System

Applicant Exalenz Bioscience , Ltd.

K-Number K162150

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DRS 2016-10-31

Disposable Pressure Transducer

Applicant Zhejiang Haisheng Medical Device Co., Ltd.

K-Number K152472

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NEY 2016-10-31

miraDry System

Applicant Miramar Labs, Inc.

K-Number K160141

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HRS 2016-10-31

Footmotion Plating System

Applicant Newclip Technics

K-Number K161448

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QEY 2016-10-31

Squirt Fluid Delivery System

Applicant Merit Medical Systems, Inc.

K-Number K162777

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