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

LLZ 2018-02-15

Velocity

Applicant Varian Medical Systems, Inc.

K-Number K173636

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GXH 2018-02-15

AtriCure cryoICE cryo-ablation probe (CRYO2)

Applicant AtriCure, Inc.

K-Number K180138

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POL 2018-02-15

Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever)

Applicant Concentric Medical, Inc.

K-Number K173352

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LYZ 2018-02-15

Vinyl Patient Examination Glove (Yellow)

Applicant Nature Medical Products Co., Ltd.

K-Number K173580

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GEX 2018-02-14

Surgical Laser fibers

Applicant Quanta System Spa

K-Number K180158

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GEX 2018-02-14

Siberian Fit

Applicant Vydence

K-Number K172439

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NKB 2018-02-14

SEURAT™ Universal Pedicle Screw System

Applicant Ctl Medical Corporation

K-Number K173185

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LEJ 2018-02-14

Sunrise 6200, Sunrise 7200

Applicant Jk-Holding GmbH

K-Number K173565

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KDJ 2018-02-14

Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K-Number K173651

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EWO 2018-02-14

Sera

Applicant Interacoustics A/S

K-Number K173567

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HIF 2018-02-14

TEMED Gas Diffuser

Applicant Temed

K-Number K173545

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DJG 2018-02-13

DRI Hydrocodone Assay

Applicant Microgenics Corporation

K-Number K173195

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