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

LEH 2016-01-08

ONLINE TDM Vancomycin Gen.3

Applicant Roche Diagnostics Operations (Rdo)

K-Number K152245

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NBW 2016-01-08

MyGlucoHealth Wireless System

Applicant Entra Health Systems

K-Number K143169

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EIH 2016-01-08

VINTAGE LD

Applicant Shofu Dental Corporation

K-Number K152392

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MQH 2016-01-08

Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette

Applicant Cook Incorporated

K-Number K151018

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BZD 2016-01-08

Sapphire

Applicant Respironics, Inc.

K-Number K152356

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LBS 2016-01-08

Direct HDL Cholesterol (HDL)

Applicant Randox Laboratories, Ltd.

K-Number K153435

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OWY 2016-01-08

BioBridge Collagen Matrix

Applicant Fibralign Corporation

K-Number K151083

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LNH 2016-01-08

MRI Dynamic Analysis Plus

Applicant Esaote, S.p.A.

K-Number K153039

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JKA 2016-01-07

TIVA¿

Applicant Velano Vascular

K-Number K152924

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EKX 2016-01-07

Tellos ISQ Buddy

Applicant Tellos Medical AB

K-Number K143445

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OMZ 2016-01-07

Edwards Balloon Catheter

Applicant Edwards Lifesciences

K-Number K153069

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HRS 2016-01-07

Treace Medical Concepts (TMC) Plating System

Applicant Treace Medical Concepts, Inc.

K-Number K153531

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