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

GXY 2017-04-14

Complete Control System

Applicant Coapt, LLC

K-Number K162891

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DQK 2017-04-14

HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable

Applicant Edwards Lifesciences, LLC

K-Number K163381

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NBW 2017-04-14

Smart Dongle Blood Glucose Monitoring System

Applicant Taidoc Technology Corporation

K-Number K162382

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HQC 2017-04-14

CENTURION Vision System (Active SentryTM)

Applicant Alcon Research, Ltd.

K-Number K161794

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HSX 2017-04-14

GMK UNI

Applicant Medacta International S.A.

K-Number K161741

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PME 2017-04-14

CeraClean

Applicant Bisco, Inc.

K-Number K163171

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MAX 2017-04-14

Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System

Applicant Rti Surgical, Inc. Dba Rti Biologics

K-Number K170643

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DZE 2017-04-14

Etgar Dental Implant System

Applicant Etgar Medical Instruments, Ltd.

K-Number K161743

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PSZ 2017-04-14

Sofia Influenza A+B FIA on Sofia 2

Applicant Quidel Corporation

K-Number K162438

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OHS 2017-04-14

Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72

Applicant Pulsaderm, LLC

K-Number K163329

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CAF 2017-04-14

Velox Nebulizer System

Applicant Pari Respiratory Equipment, Inc.

K-Number K162785

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GEI 2017-04-14

Saf-T-Vac Smoke and Fluid Evacuator

Applicant Surgical Technology Laboratories, Inc.

K-Number K170582

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