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

DQO 2017-01-06

NAMIC ClearaCIL Contrast Injection Lines

Applicant AngioDynamics, Inc.

K-Number K163141

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DRE 2017-01-06

Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set

Applicant Cardiacassist, Inc.

K-Number K162181

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PKL 2017-01-06

SureClip(TM) Repositionable Hemostasis Clip

Applicant Micro-Tech (Nanjing) Co., Ltd.

K-Number K161463

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GXQ 2017-01-06

DuraGen Secure Dural Regeneration Matrix

Applicant Integra LifeSciences Corporation

K-Number K163456

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LFZ 2017-01-06

LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set

Applicant DiaSorin, Inc.

K-Number K162969

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MOS 2017-01-06

8ch Knee-Foot SPEEDER

Applicant Quality Electrodynamics, LLC

K-Number K162946

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JXI 2017-01-06

NeuraGen 3D Nerve Guide Matrix

Applicant Integra LifeSciences Corporation

K-Number K163457

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BXN 2017-01-06

MultiStim ECO

Applicant PAJUNK GmbH Medizintechnologie

K-Number K162086

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LNH 2017-01-06

Ingenia 1.5T CX and Ingenia 3.0T CX R5.3

Applicant Philips Medical Systems Nederland B.V.

K-Number K162931

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KPO 2017-01-06

PrismaSATE

Applicant Baxter Healthcare Corporation

K-Number K162887

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MPB 2017-01-06

Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray

Applicant Cook Incorporated

K-Number K161504

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GEI 2017-01-06

Disc-FX System

Applicant Elliquence, LLC

K-Number K162490

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