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

FOZ 2019-05-17

Cook Unimpregnated Central Venous Catheter

Applicant Cook Incorporated

K-Number K182252

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KWI 2019-05-17

Revolution Radial Head

Applicant Ignite Orthopedics, Inc.

K-Number K183618

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OAP 2019-05-17

iRestore Professional 282

Applicant Freedom Laser Therapy, Inc.

K-Number K183417

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OLO 2019-05-17

Navigation Enabled Instruments

Applicant Stryker

K-Number K183381

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DSH 2019-05-16

Carnation Ambulatory Monitor

Applicant Bardy Diagnostics, Inc.

K-Number K191000

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CAZ 2019-05-16

VPC

Applicant PAJUNK GmbH Medizintechnologie

K-Number K190345

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JWH 2019-05-16

Precision Casting Solutions Total Knee System

Applicant Precision Casting Solutions, Inc.

K-Number K190355

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HIH 2019-05-16

Aveta System

Applicant Meditrina, Inc.

K-Number K190372

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DXN 2019-05-16

Fully Automatic Electronic Blood Pressure Monitor

Applicant Andon Health Co, Ltd.

K-Number K183534

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IYN 2019-05-16

Dolphin/IQ, Dolphin/4D and Dolphin/MAX

Applicant Viasonix , Ltd.

K-Number K191023

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LPL 2019-05-16

Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contac

Applicant Unicon Optical Co., Ltd.

K-Number K182734

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LLZ 2019-05-16

syngo.via (Version VB40A)

Applicant Siemens Healthcare GmbH

K-Number K191040

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