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

PKL 2018-06-01

Single Use MultiClip Device

Applicant Micro-Tech (Nanjing) Co., Ltd.

K-Number K180325

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ONB 2018-06-01

NEOSHIELD

Applicant JMS North America Corporation

K-Number K172499

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DPS 2018-06-01

Kenz Cardico1211

Applicant Suzuken Co., Ltd.

K-Number K172068

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GXY 2018-06-01

Silverwear Silver Pro Garment Device

Applicant Media Plus, LLC

K-Number K171798

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NUC 2018-06-01

BioNude Lubricant

Applicant Good Clean Love, Inc.

K-Number K180136

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OAP 2018-06-01

Hair Up

Applicant Y & J Bio Co., Ltd.

K-Number K180617

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OMP 2018-06-01

Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System

Applicant Kci USA, Inc.

K-Number K180855

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BSP 2018-06-01

Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.) Syringes., Portex EpiFuse Catheter Connector, Portex Regional Anaesthesia Portfolio Filters

Applicant Smiths Medical Asd, Inc.

K-Number K172410

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GEI 2018-06-01

InMode System with Fractora3D/3D-90 Applicators

Applicant Inmode MD , Ltd.

K-Number K180189

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DZE 2018-06-01

UF(II) Wide Fixture

Applicant Dio Corporation

K-Number K173975

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KPL 2018-06-01

Colonic Plus Regular, Small, and Straight Shape Hydrokit

Applicant Colonic Plus

K-Number K180800

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NXC 2018-06-01

Smart Moves Complete

Applicant Great Lakes Orthodontics, Ltd.

K-Number K172765

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