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

DZE 2016-11-30

Zeramex P6 Dental Implant System

Applicant Dentalpoint AG

K-Number K163043

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GCJ 2016-11-30

ReliaCatch Specimen Retrieval Bag 10mm; ReliaCatch Specimen Retrieval Bag 12mm

Applicant Covidien

K-Number K163102

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IYN 2016-11-30

Clarius Ultrasound System

Applicant Clarius Mobile Health Corp.

K-Number K163138

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DWF 2016-11-30

Protek Solo 24 Fr Venous Cannula Set

Applicant Cardiacassist, Inc.

K-Number K162214

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NBW 2016-11-30

One Drop Blood Glucose Monitoring System

Applicant Agamatrix, Inc.

K-Number K161834

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QSY 2016-11-29

InnoSEAL Hemostatic Pad

Applicant Innotherapy, Inc.

K-Number K161013

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MOS 2016-11-29

TxRx Knee 15 Flare MR Coil 3.0T

Applicant Quality Electrodynamics, LLC

K-Number K163066

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GKZ 2016-11-29

UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System

Applicant Beckman Coulter, Inc.

K-Number K162414

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PIF 2016-11-29

Medline ENFit Syringe

Applicant Medline Industries, Inc.

K-Number K160642

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GCJ 2016-11-29

Well Lead Extraction Bag

Applicant Well Lead Medical Co., Ltd.

K-Number K160801

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NQQ 2016-11-29

LuminScan (TM) Imaging System

Applicant Micro-Tech (Nanjing) Co., Ltd.

K-Number K162466

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MSS 2016-11-29

Lenstec LC Injection system

Applicant Lenstec, Inc.

K-Number K161776

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