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

OLI 2017-11-22

Vevazz LED

Applicant Vevazz, LLC

K-Number K172111

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JAK 2017-11-22

CereTom Elite

Applicant Neurologica Corporation, A Subsidiary of Samsung Electronics

K-Number K172539

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OVE 2017-11-22

Velofix SA Cervical Cage

Applicant U&I Corporation

K-Number K172424

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DAP 2017-11-22

HemosIL D-Dimer HS 500

Applicant Instrumentation Laboratory CO

K-Number K172903

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GWN 2017-11-22

I-Portal Portable Assessment System - Nystagmograph (I-PAS)

Applicant Neuro Kinetics, Inc.

K-Number K171884

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DJG 2017-11-22

CEDIA Heroin Metabolite (6-AM) Assay

Applicant Microgenics Corporation

K-Number K173183

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MOS 2017-11-22

AIR Anterior Array, AIR Posterior Array

Applicant Ge Healthcare Coils (Usa Instruments, Inc.)

K-Number K172695

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GBM 2017-11-22

Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent

Applicant Cook Incorporated

K-Number K172278

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OLO 2017-11-22

OrthAlign Plus System

Applicant Orthalign, Inc.

K-Number K172462

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OWB 2017-11-22

Azurion series R1.2

Applicant Philips Medical Systems Nederland B.V.

K-Number K172822

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PIE 2017-11-22

EsoFLIP® ES-310 Balloon Catheter

Applicant Crospon, Ltd.

K-Number K172128

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NTK 2017-11-22

CamX Triton HD Proxi Head

Applicant Duerr Dental AG

K-Number K172007

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