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

LZA 2018-06-14

Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low-Dermatitis Potential Claim and Tested For Use with Chemotherapy Drugs (White)

Applicant Hartalega Sdn Bhd

K-Number K180505

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ODP 2018-06-14

TiWAVE-C™ Porous Titanium Cervical Cage

Applicant Kalitec Direct, LLC

K-Number K180401

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FMI 2018-06-14

Disposable Sterile Needle

Applicant Jiangsu Caina Medical Co.,Ltd

K-Number K172938

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FHN 2018-06-14

Ligation Device

Applicant Leo Medical Co., Ltd.

K-Number K172985

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DQX 2018-06-14

Double Flexible Tipped Wire Guides

Applicant Cook Incorporated

K-Number K181351

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DQK 2018-06-14

CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module

Applicant Biosense Webster, Inc.

K-Number K173977

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GWQ 2018-06-14

Natus Brain Monitor Amplifier

Applicant Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)

K-Number K180290

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NGX 2018-06-14

BTL 799-2

Applicant BTL Industries, Inc.

K-Number K180813

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NBW 2018-06-14

POGO Automatic Blood Glucose Monitoring System

Applicant Intuity Medical, Inc.

K-Number K181316

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MUI 2018-06-13

EcoVue Sterile and Non-Sterile Ultrasound Gels

Applicant H R Pharmaceuticals, Inc.

K-Number K181363

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MQB 2018-06-13

PEDRA-17F Digital Flat Panel X-ray Detector

Applicant Radisen, Inc.

K-Number K180989

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KCT 2018-06-13

Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories

Applicant Case Medical, Inc.

K-Number K173259

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