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

PDQ 2017-07-18

ES2 Neuromonitoring Accessory Instruments

Applicant Stryker Corporation

K-Number K171807

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NUC 2017-07-18

JO Agapé Personal Lubricant

Applicant United Consortium

K-Number K171021

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NPM 2017-07-18

OSSIX BONE

Applicant Datum Dental, Ltd.

K-Number K163714

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LZA 2017-07-18

Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue

Applicant Ug Global Resources Sdn. Bhd.

K-Number K162510

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MWP 2017-07-18

Faxitron Bioptics Speciemen Radiography System

Applicant Faxitron Bioptics, LLC

K-Number K170786

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EGS 2017-07-18

Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE)

Applicant Bonart Co., Ltd.

K-Number K162856

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PTI 2017-07-18

20G x 5/8 Pro-Lock CT Safety Infusion Set

Applicant Medcomp (Dba Medical Components, Inc.)

K-Number K171333

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IYO 2017-07-18

Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound System

Applicant Edan Instruments, Inc.

K-Number K171824

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LLZ 2017-07-18

Examion X-AQS

Applicant Examion GmbH

K-Number K170729

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DWJ 2017-07-18

Altrix Temperature Management Wraps

Applicant Stryker Medical

K-Number K171149

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NJM 2017-07-18

Inspire ICE aka Inspire ICE Clear Brackets

Applicant Ormco Corporation

K-Number K171844

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LLZ 2017-07-18

Arterys Viewer

Applicant Arterys, Inc.

K-Number K171544

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