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

HQD 2016-12-08

Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens

Applicant Acuity Polymers, Inc.

K-Number K162005

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JIT 2016-12-08

DC-UIBC-CAL

Applicant Sekisui Diagnostics P.E.I., Inc.

K-Number K163078

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DHR 2016-12-07

Rheumatoid Factor (RF) Kit for use on SPAPLUS

Applicant The Binding Site Group , Ltd.

K-Number K160070

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MBI 2016-12-07

SUTUREFIX Curved Suture Anchor

Applicant Smith and Nephew, Inc.

K-Number K163034

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DZE 2016-12-07

s-Clean OneQ-SL Narrow Implant System

Applicant Dentis Co., Ltd.

K-Number K161244

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ODP 2016-12-07

OIC Cervical PEEK Spacer

Applicant The Orthopaedic Implant Company

K-Number K160222

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KPR 2016-12-07

GC70

Applicant Samsung Electronics Co., Ltd.

K-Number K163115

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LLZ 2016-12-07

CT CoPilot

Applicant Zepmed, LLC

K-Number K161322

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FDF 2016-12-06

DiLumen Endolumenal Interventional Platform

Applicant Lumendi, LLC

K-Number K162428

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MRZ 2016-12-06

Hospira Sapphire Sets

Applicant Hospira, Inc.

K-Number K160492

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ODP 2016-12-06

ShurFit CpTi-HA ACIF Interbody Fusion System

Applicant Precision Spine, Inc.

K-Number K161809

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FPA 2016-12-06

Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension Sets

Applicant Quest Medical, Inc.

K-Number K162304

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