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

FED 2016-01-07

Well Lead Ureteral Access Sheath

Applicant Well Lead Medical Co., Ltd.

K-Number K151084

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NKG 2016-01-07

VuePoint OCT System

Applicant Nu Vasive, Incorporated

K-Number K153336

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JWH 2016-01-07

ConforMIS iTotal Posterior Stabilized Knee Replacement System

Applicant Conformis, Inc.

K-Number K153217

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MAX 2016-01-06

Amendia Interbody Fusion Devices

Applicant Amendia, Inc.

K-Number K151310

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HSB 2016-01-06

Piccolo Composite® Nailing System

Applicant CarboFix Orthopedics , Ltd.

K-Number K153536

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KRA 2016-01-06

ClariVein IC

Applicant Vascular Insights, LLC

K-Number K153502

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KTT 2016-01-06

Galaxy UNYCO System

Applicant Orthofix Srl

K-Number K153233

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NUJ 2016-01-06

Medline ReNewal Reprocessed Endopath Endoscopic Instruments

Applicant Surgical Instrument Services and Savings, Inc.

K-Number K152313

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DQA 2016-01-06

Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D

Applicant Guangdong Biolight Meditech Co., Ltd.

K-Number K151287

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PML 2016-01-06

KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set

Applicant Medtronic Sofamor Danek USA, Incorporated

K-Number K152604

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GAD 2016-01-06

OTELO LL

Applicant Spineart

K-Number K151104

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DXC 2016-01-06

VasoStat Hemostasis Device

Applicant Forge Medical, Inc.

K-Number K153259

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