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

FGE 2017-01-25

Reliant Multistage Dilatation Balloon Catheter

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

K-Number K162226

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MAX 2017-01-25

Altus Spine Interbody Fusion System

Applicant Altus Partners, LLC

K-Number K160976

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MBB 2017-01-25

StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis

Applicant Biomet, Inc.

K-Number K161273

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DXC 2017-01-25

PreludeSYNC Radial Compression Device

Applicant Merit Medical Systems, Inc.

K-Number K162988

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MBI 2017-01-25

CrossFT Knotless Suture Anchor with Disposable Driver

Applicant Conmed Corporation

K-Number K163258

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NKB 2017-01-25

PASS LP Spinal System

Applicant Medicrea International SA

K-Number K162786

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GEI 2017-01-24

Barrx Anorectal RFA Wand

Applicant Covidien, LLC

K-Number K162802

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EHD 2017-01-24

EzRay Air W

Applicant VATECH Co., Ltd.

K-Number K163705

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HSB 2017-01-24

ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System

Applicant Orthofix Srl

K-Number K161466

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ODP 2017-01-24

nvc

Applicant Nvision Biomedical Technologies, LLC

K-Number K170074

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LON 2017-01-24

VITEK 2 AST-GN Tigecycline (<0.5->8 ug/mL)

Applicant bioMerieux, Inc.

K-Number K163006

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LZA 2017-01-24

Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White); Dark Violet Blue (DVBU); Dark Blue (DKBU)

Applicant Hartalega Sdb. Bhd.

K-Number K162924

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