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

NPL 2016-08-04

OSSIX PLUS

Applicant Datum Dental, Ltd.

K-Number K160281

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DXN 2016-08-04

Fully Automatic Electronic Blood Pressure Monitor

Applicant Andon Health Co, Ltd.

K-Number K160563

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NPL 2016-08-04

OSSIX VOLUMAX

Applicant Datum Dental, Ltd.

K-Number K153549

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LYY 2016-08-04

Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove

Applicant Hartalega Sdn Bhd

K-Number K161006

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MMK 2016-08-04

Med-Tainer Single Deposit Container

Applicant Snyder Industries, Inc.

K-Number K153274

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LYY 2016-08-04

A1 Glove Powder Free Latex Patient Examination Gloves with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein)

Applicant A1 Glove Sdn Bhd

K-Number K153744

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NKB 2016-08-04

Mont Blanc and Mont Blanc MIS Spinal Systems

Applicant Spineway SA

K-Number K161387

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MRW 2016-08-04

FacetBRIDGE® System

Applicant Ldr Spine USA, Inc.

K-Number K161798

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FRO 2016-08-04

Microlyte Ag

Applicant Imbed Biosciences, Inc.

K-Number K153756

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NHX 2016-08-04

ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials.

Applicant Axis-Shield Diagnostics Limited

K-Number K153551

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FIP 2016-08-04

MED-TECH Water Systems Inc Exchangeable Carbon Tanks for Dialysis

Applicant Med-Tech Water Systems, Inc.

K-Number K153329

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EBF 2016-08-04

CAPO BULK FILL

Applicant Schuetz Dental GmbH

K-Number K152471

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