Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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

MAI 2017-05-05

Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor

Applicant Nanova Biomaterials, Inc.

K-Number K163672

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KGO 2017-05-05

POLYCHLOROPRENE POWDER FREE SURGICAL GLOVE (GREEN)

Applicant Hartalega Sdn Bhd

K-Number K170152

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OOE 2017-05-05

LENSAR Laser System - fs 3D (LLS-fs 3D)

Applicant Lensar, Inc.

K-Number K170576

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PUJ 2017-05-05

ARK Voriconazole II Assay Test System

Applicant Ark Diagnostics, Inc.

K-Number DEN160033

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CBN 2017-05-05

MINISCAV

Applicant Sedation Systems, LLC

K-Number K160950

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JAK 2017-05-05

In Reach

Applicant Curvebeam, LLC

K-Number K170789

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MUM 2017-05-04

Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered

Applicant Cook Ireland, Ltd.

K-Number K163468

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PIO 2017-05-04

Cedic Enteral ENFit Transition Connectors

Applicant Cedic S.R.L.

K-Number K162254

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EIH 2017-05-04

Eclipse Kiss Zirconia

Applicant Ams

K-Number K163238

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LLZ 2017-05-04

Nucleus Image Management System

Applicant Nucleushealth, LLC

K-Number K171130

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FDF 2017-05-04

Flex Robotic System and Flex Colorectal Drive

Applicant Medrobotics Corporation

K-Number K162330

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GEI 2017-05-04

Snowden-Pencer MicroLap 3mm Laparoscopic Instruments

Applicant Carefusion 2200, Inc.

K-Number K163615

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