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

FEQ 2017-01-04

AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON

Applicant United State Endoscopy Group, Inc.

K-Number K163424

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LLZ 2017-01-04

CephSimulation

Applicant Anatomage, Inc.

K-Number K161270

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MWI 2017-01-04

Truscope Ultra Patient Monitor

Applicant Guangdong Biolight Meditech Co., Ltd.

K-Number K162234

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IYN 2017-01-04

ACUSON P500 Ultrasound System

Applicant Siemens Medical Solutions USA, Inc.

K-Number K163396

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KPR 2017-01-04

DigitalDiagnost C50

Applicant Philips Healthcare (Suzhou) Co., Ltd.

K-Number K163410

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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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