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

JWY 2019-03-22

MTS Gentamicin 0.016 - 256 µg/mL

Applicant Liofilchem s.r.l.

K-Number K190252

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CCK 2019-03-22

Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Line with O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line with O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling Line

Applicant Oridion Medical 1987 , Ltd.

K-Number K181624

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OBP 2019-03-22

Nexstim Navigated Brain Therapy (NBT) System 2

Applicant Nexstim Plc

K-Number K182700

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NZT 2019-03-22

OARtrac System

Applicant Radialdyne, LLC

K-Number K182395

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OLO 2019-03-22

ROSA ONE Spine application

Applicant Medtech S.A

K-Number K182848

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DQY 2019-03-22

Telescope Guide Extension Catheter

Applicant Medtronic, Inc.

K-Number K183353

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MOF 2019-03-22

Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18 Guidewire, 200cm, Support Profile

Applicant Scientia Vascular, LLC

K-Number K183608

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NEU 2019-03-22

EnVisio Navigation Sytem

Applicant Elucent Medical, Inc.

K-Number K183400

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LZA 2019-03-22

Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs

Applicant He Chuang Plastic & Rubber Co., Ltd.

K-Number K182554

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FRG 2019-03-22

HALYARD SMART-FOLD* Sterilization Wrap (H450, H650)

Applicant Owens & Minor Halyard, Inc.

K-Number K181959

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HWC 2019-03-22

OsteoCentric Bone Plate and Screw System

Applicant Osteocentric Trauma

K-Number K190430

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GZB 2019-03-22

Nalu Neurostimulation System

Applicant Boston Scientific Neuromodulation

K-Number K183047

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