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

NBW 2017-10-17

SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT Professional System, SD LipidoCare BT Home System

Applicant Sd Biosensor

K-Number K160282

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PLA 2017-10-17

EnsoETM

Applicant Attune Medical

K-Number K172493

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GEI 2017-10-17

X-SURGE

Applicant Genicon, Inc.

K-Number K171752

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LYA 2017-10-17

Chitogel Endoscopic Sinus Surgery Kit

Applicant Chitogel, Ltd.

K-Number K172179

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HKY 2017-10-17

Applanation tonometer AT-1

Applicant Takagi Seiko Co., Ltd.

K-Number K172728

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FET 2017-10-17

4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB, 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EA

Applicant Olympus Medical Systems Corp.

K-Number K172817

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MWI 2017-10-17

RVS-100 Vital Signs Monitor

Applicant Rudolf Riester GmbH

K-Number K170538

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GEX 2017-10-17

585

Applicant Quanta System Spa

K-Number K172198

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DRE 2017-10-16

Coaxial Dilator Set (Micro-Introducer)

Applicant Galt Medical Corp.

K-Number K172487

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LZF 2017-10-16

OptiScanner 5000 Glucose Monitoring System

Applicant Optiscan Biomedical Corp.

K-Number K162042

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OCC 2017-10-16

Solana RSV+hMPV Assay

Applicant Quidel Corporation

K-Number K171974

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MGQ 2017-10-16

HylaGuard Moisturizing Cream

Applicant Founders Science Group, LLC

K-Number K171879

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