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

LPL 2017-01-04

Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A)

Applicant Supervision Optimax Sdn Bhd

K-Number K162223

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GEI 2017-01-04

Relign System

Applicant Relign Corporation

K-Number K162770

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LSE 2017-01-04

LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set

Applicant DiaSorin, Inc.

K-Number K162959

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IYN 2017-01-03

X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System

Applicant Sonoscape Medical Corp.

K-Number K163427

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HSX 2017-01-03

MOTO Partial Knee System

Applicant Medacta International S.A.

K-Number K162084

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HCG 2017-01-03

Axium Prime Detachable Coil System

Applicant Micro Therapeutics, Inc. d/b/a ev3 Neurovascular

K-Number K162704

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CAC 2017-01-03

Haemonetics Cell Saver Elite/Elite+ Autotransfusion System

Applicant Haemonetics Corporation

K-Number K162423

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OCL 2017-01-03

Isolator Multifunctional Linear Pen

Applicant AtriCure, Inc.

K-Number K163408

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LLZ 2017-01-03

syngo.via MI Workflows

Applicant Siemens Medical Solutions USA, Inc.

K-Number K163421

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HAW 2016-12-30

Cranial Reducing Tubes

Applicant Medtronic Navigation, Inc.

K-Number K162604

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GYB 2016-12-30

NuFACE Gel Primer

Applicant Carol Cole Company

K-Number K161654

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LNH 2016-12-30

MultiBand SENSE

Applicant Philips Medical Systems Nederland B.V.

K-Number K162940

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