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

CGN 2016-11-04

Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set

Applicant Diazyme Laboratories

K-Number K161646

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KRA 2016-11-04

SwiftNINJA Microcatheter

Applicant Merit Medical Systems, Inc.

K-Number K161921

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LXM 2016-11-04

VSTAAR AdjusteR

Applicant Spinal Acoustics, LLC

K-Number K160278

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KXK 2016-11-04

Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source

Applicant Source Production and Equipment Co., Inc.

K-Number K162573

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DQK 2016-11-04

CardioInsight Cardiac Mapping System

Applicant Cardioinsight Technologies, Inc.

K-Number K162440

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MUU 2016-11-04

Lipogems System

Applicant Lipogems International Spa

K-Number K161636

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JSM 2016-11-04

Puritan Fecal Opti-Swab Collection and Transport System

Applicant Puritan Medical Products, LLC

K-Number K162284

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FYC 2016-11-04

PRIMAGARD Isolation Gown (AAMI PB70 Level 3)

Applicant Primed Medical Products, Inc.

K-Number K160361

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IYO 2016-11-03

MicrUs

Applicant Telemed

K-Number K161968

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JAK 2016-11-03

Vitrea CT Dual Energy Image View

Applicant Vital Images, Inc.

K-Number K161157

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HSX 2016-11-03

Persona Partial Knee System

Applicant Biomet, Inc.

K-Number K161592

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PSW 2016-11-03

CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical TD-5 High Level Disinfectant, CS Medical TD-8 High Level Disinfectant

Applicant Cs Medical, LLC

K-Number K160921

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