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

NDN 2017-04-12

HIGH V+

Applicant Teknimed Sas

K-Number K161114

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PSY 2017-04-12

Philips IntelliSite Pathology Solution

Applicant Philips Medical Systems Nederland B.V.

K-Number DEN160056

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GZL 2017-04-12

Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes

Applicant Ad-Tech Medical Instrument Corporation

K-Number K163355

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FMF 2017-04-12

BD Ultra-Fine Insulin Syringe, BD Ultra-Fine II Insulin Syringe, BD Insulin Syringes with the BD Ultra-Fine needle and BD Insulin Syringes with Micro-Fine IV Needle

Applicant Becton Dickinson & Company

K-Number K170386

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IYE 2017-04-11

CyberKnife Treatment Delivery System

Applicant Accuray Incorportaed

K-Number K170788

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LPN 2017-04-11

Bausch + Lomb Sensitive Eyes Plus Saline Solution

Applicant Bausch & Lomb, Incorporated

K-Number K170483

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PTC 2017-04-11

Nova Max Uric Acid Monitoring System

Applicant Nova Biomedical Corporation

K-Number K160990

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HKI 2017-04-11

HAAG-STREIT FUNDUS MODULE 300

Applicant Optomed OY

K-Number K163021

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GXY 2017-04-11

MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96

Applicant Neurovirtual USA, Inc.

K-Number K163547

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GDW 2017-04-11

OptiFix Open Absorbable Fixation System - 20 absorbable fasteners

Applicant C.R. Bard, Inc.

K-Number K163698

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IYN 2017-04-11

LOGIQ S8

Applicant GE Healthcare

K-Number K170445

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DYX 2017-04-11

MINNE TIES MMF Suture System

Applicant Summit Medical, Inc.

K-Number K162046

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