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

GXY 2018-01-05

Electrodes with silver conductive

Applicant Shenzhen Konmed Technology Co., Ltd.

K-Number K171721

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LON 2018-01-05

BD Phoenix Automated Microbiology System - GN Ceftolozane/tazobactam (0.25/4-32/4 ug/mL)

Applicant Becton, Dickinson and Company

K-Number K173252

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FIP 2018-01-05

EON Portable Reverse Osmosis Water Purification System

Applicant Cantel

K-Number K171099

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BSP 2018-01-05

Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles

Applicant Zhejiang Kindly Medical Devices Co., Ltd.

K-Number K171518

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EGS 2018-01-05

STRONG Dental Handpieces

Applicant Saeshin Precision Co., Ltd.

K-Number K171436

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LLZ 2018-01-05

ViewPoint 6

Applicant Ge Medical Systems Ultrasound and Primary

K-Number K173456

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MBI 2018-01-05

ToggleLoc System

Applicant Biomet, Inc.

K-Number K173278

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DSH 2018-01-04

ePatch

Applicant Braemar Manufacturing, LLC

K-Number K171410

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BZQ 2018-01-04

EarlySense Bed Sensing Unit

Applicant Earlysense, Ltd.

K-Number K171836

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HIH 2018-01-04

LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI cable and on-board LCD-6 units, LiNA OperaScope Recording Module

Applicant Lina Medical Aps

K-Number K171113

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DQY 2018-01-04

Attain Assist CS Access Catheter

Applicant Creganna Medical Also Doing Business AS Ceganna Tactx Medica

K-Number K171819

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CAD 2018-01-04

Tec 820, Tec 850

Applicant Datex-Ohmeda, Inc.

K-Number K172702

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