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

NUJ 2018-03-27

NES Reprocessed RF Stylet (RFS)

Applicant Northeast Scientific, Inc. (Nes)

K-Number K173214

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ERL 2018-03-27

OCM-G1 Attachment

Applicant The Anspach Effort, Inc.

K-Number K180063

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OOE 2018-03-27

LenSx Laser System

Applicant Alcon Laboratories, Inc.

K-Number K173660

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LFL 2018-03-26

Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw Dissectors (multiple lengths), Sonicision Battery Charger, Sonicision Battery Insertion Guide

Applicant Covidien, LLC

K-Number K180149

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LRK 2018-03-26

REST EAZY Appliance

Applicant Insert Molding Solutions, Inc.

K-Number K172760

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FAD 2018-03-26

Black Silicone Filiform Double Pigtail Stent Set

Applicant Cook Incorporated

K-Number K172017

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NBY 2018-03-26

C-PTFETM Surgical Suture

Applicant Cp Medical, Inc.

K-Number K173922

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QAR 2018-03-26

ThermoNeuroModulation Device, TNM Device

Applicant Scion Neurostim, LLC

K-Number DEN170023

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JEY 2018-03-26

OssBuilder System

Applicant Osstem Implant Co., Ltd.

K-Number K172354

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HRX 2018-03-26

DISKOM

Applicant Biopsybell S.R.L.

K-Number K180315

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CAF 2018-03-26

SmartTouch

Applicant Adherium (Nz), Ltd.

K-Number K173310

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JXG 2018-03-24

EKOS ultrasound EVD Device, EVD Control Unit

Applicant Btg International, Inc.

K-Number K172035

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