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

KHE 2017-05-14

Wondfo One Step Fecal Occult Blood (FOB) Test

Applicant Guangzhou Wondfo Biotech Co., Ltd.

K-Number K162333

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NDY 2017-05-12

N Latex Cystatin C; N Protein Standard UY

Applicant Siemens Healthcare Diagnostics Products GmbH

K-Number K171072

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MWI 2017-05-12

Unity Network ID

Applicant GE Healthcare

K-Number K170199

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MQL 2017-05-12

Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase

Applicant Genea Biomedx Pty, Ltd.

K-Number K161261

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HRS 2017-05-12

Piccolo Composite® Plate System

Applicant CarboFix Orthopedics , Ltd.

K-Number K170401

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JIL 2017-05-12

iChemVELOCITY Automated Urine Chemistry System

Applicant Iris Diagnostics, A Division of Iris International, Inc.

K-Number K171083

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NUH 2017-05-12

Avazzia

Applicant Avazzia, Inc.

K-Number K162392

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FLE 2017-05-12

Belimed Steam Sterilizer MST-H TOP 5000

Applicant Belimed AG

K-Number K170228

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IZL 2017-05-12

GM85

Applicant Samsung Electronics Co., Ltd.

K-Number K171119

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IOR 2017-05-11

Winner Transfer Wheelchair

Applicant Winner SG Pte, Ltd.

K-Number K162328

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JWH 2017-05-11

ANTHEM CR Total Knee System

Applicant Smith & Nephew, Inc.

K-Number K170648

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GEI 2017-05-11

Active Needle Endoscopic Treatment (ANET) Electrosurgical Applicator

Applicant Spiration, Inc.

K-Number K170990

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