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

PEK 2016-05-04

Precision Spine Interspinous Plate System

Applicant Precision Spine, Inc.

K-Number K160568

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FGE 2016-05-04

Soehendra Stent Retriever

Applicant Wilson-Cook Medical, Inc.

K-Number K161203

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NKB 2016-05-04

Xenco Medical Pedicle Screw System

Applicant Xenco Medical, LLC

K-Number K160986

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GEI 2016-05-04

Electrosurgical Generator ESG-200

Applicant Olympus Winter & Ibe GmbH

K-Number K160639

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KPI 2016-05-04

Yarlap II

Applicant International Trade Group, Inc.

K-Number K160773

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MAX 2016-05-04

SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF

Applicant Spinevision S.A.

K-Number K153783

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MQL 2016-05-04

Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit-Thaw Oocytes, Embryos and PN zygotes Vitrification Thaw Kit

Applicant Irvine Scientific

K-Number K160006

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KNT 2016-05-04

GastriSail Gastric Positioning System 40 Fr/CH (13.3mm)

Applicant Covidien, LLC

K-Number K160654

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ODG 2016-05-03

Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device

Applicant Boston Scientific Corporation

K-Number K160845

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BTT 2016-05-03

HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010

Applicant Hamilton Medical AG

K-Number K152029

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OVD 2016-05-03

ENZA Zero-Profile Anterior Interbody Fusion

Applicant Camber Spine Technologies

K-Number K153720

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DKZ 2016-05-03

UCP COMPACT DRUG TESTS

Applicant Ucp Biosciences, Inc.

K-Number K152908

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