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

LKN 2018-11-01

Spectra Optia Apheresis System

Applicant Terumobct, Inc.

K-Number K181049

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DZE 2018-11-01

Implantswiss Dental Implant System, Implantswiss Dental Abutment System

Applicant Novodent SA

K-Number K181266

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NBW 2018-11-01

GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring System

Applicant I-Sens, Inc.

K-Number K181273

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DXT 2018-11-01

MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit

Applicant Bayer Medical Care, Inc.

K-Number K182276

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HRS 2018-11-01

DePuy Synthes Trauma Orthopedic Plates and Screws

Applicant Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.

K-Number K180310

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DXT 2018-11-01

MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT

Applicant Bayer Medical Care, Inc.

K-Number K182273

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DFH 2018-11-01

N Latex FLC kappa assay, N Latex FLC lambda assay

Applicant Siemens Healthcare Diagnostics Products GmbH

K-Number K182098

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FCG 2018-11-01

Clear-Tip EUS-FNA

Applicant Finemedix Co., Ltd.

K-Number K180363

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LPL 2018-11-01

Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens

Applicant Largan Medical Co., Ltd.

K-Number K182523

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GXY 2018-11-01

DAEHAN Adhesive Surface Electrodes

Applicant Daehan Medical Systems Co., Ltd.

K-Number K180247

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HRS 2018-11-01

Medline Unite Mini Plates and Screws

Applicant Medline Industries, Inc.

K-Number K181820

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EIH 2018-10-31

LUXEN Zr, LUXEN Smile

Applicant Dentalmax Co., Ltd.

K-Number K171585

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