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

MUI 2018-01-08

Other-Sonic Transmission Gel

Applicant Pharmaceutical Innovations, Inc.

K-Number K163023

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LLZ 2018-01-08

cNeuro cMRI

Applicant Combinostics OY

K-Number K171328

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OLX 2018-01-08

PreOp

Applicant Epilog

K-Number K172858

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KGO 2018-01-08

Pristeen (Latex Surgeons Gloves Powder Free, Polymer coated with protein content labeling claim of 50 ug/dm2 or less per glove of extractable protein

Applicant Beta Healthcare Products Pvt., Ltd.

K-Number K172942

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IYN 2018-01-08

DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K173471

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NXC 2018-01-05

Sureclear aligners

Applicant Emergo Global Consulting, LLC

K-Number K171860

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FEQ 2018-01-05

AquaShield System CO2- Fujifilm

Applicant United States Endoscopy Group, Inc.

K-Number K173650

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OAP 2018-01-05

Hair Up

Applicant Y & J Bio Co., Ltd.

K-Number K172968

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DQX 2018-01-05

Roadrunner Extra Support Wire Guide

Applicant Cook Incorporated

K-Number K171948

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OLO 2018-01-05

Spineology Navigation Instruments

Applicant Spineology, Inc.

K-Number K172518

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EBC 2018-01-05

Pulpdent (Activa) Pit and Fissure Sealant with MCP

Applicant Pulpdent Corporation

K-Number K172169

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PLA 2018-01-05

EnsoETM

Applicant Attune Medical

K-Number K172029

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