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

ODP 2016-10-26

NuVasive CoRoent Small Ti-C System

Applicant Nu Vasive, Incorporated

K-Number K162138

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OBO 2016-10-26

PLEX Elite 9000 SS-OCT

Applicant Carl Zeiss Meditec, Inc.

K-Number K161194

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GEX 2016-10-26

NeuroBlate System

Applicant Monteris Medical, Inc.

K-Number K162762

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LZO 2016-10-26

Zimmer M/L Taper Hip Prosthesis

Applicant Zimmer, Inc.

K-Number K161830

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JJX 2016-10-26

Multichem A1c

Applicant Technopath Manufacturing

K-Number K162514

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NLH 2016-10-26

Reprocessed Orbiter ST Steerable Diagnostic EP Catheter

Applicant Innovative Health, LLC

K-Number K161393

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KWQ 2016-10-26

FortiBridge Anterior Cervical Plate System

Applicant Nanovis Spine, LLC

K-Number K162250

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GEH 2016-10-25

truFreeze System

Applicant CSA Medical, Inc.

K-Number K162695

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JSO 2016-10-25

chromID MRSA

Applicant bioMerieux, Inc.

K-Number K162076

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PGX 2016-10-25

Solana Strep Complete Assay

Applicant Quidel Corporation

K-Number K162274

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LZG 2016-10-25

t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater

Applicant Tandem Diabetes Care, Inc.

K-Number K162080

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KPS 2016-10-25

Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CT

Applicant Siemens Medical Solutions USA, Inc.

K-Number K162736

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