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

PEK 2016-07-28

Spinal Elements' Spinous Process Plate System

Applicant Spinal Elements, Inc.

K-Number K160465

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FYC 2016-07-28

Cardinal Health Isolation Gown

Applicant Cardinal Health200, LLC

K-Number K160339

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KGO 2016-07-28

POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVE

Applicant Hartalega Sdn Bhd

K-Number K161008

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DHN 2016-07-28

AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM

Applicant Aesku Systems GmbH&Co.Kg

K-Number K153117

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GEX 2016-07-28

Medilas H Laser Fibers

Applicant Dornier Medtech America, Inc.

K-Number K161771

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PGZ 2016-07-28

XSTAT-12, 3-Pack, XSTAT-12, 1-Pack

Applicant Revmedx, Inc.

K-Number K161020

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LLZ 2016-07-28

SIMPLANT Online Case Review and SIMPLANT Editor

Applicant Dentsply Sirona

K-Number K161118

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MQL 2016-07-28

PBS(-), Phosphate Buffered Saline

Applicant Kitazato Biopharma Co., Ltd.

K-Number K160863

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OVE 2016-07-28

Genesys Spine Apache® Anchored Cervical Interbody Fusion System

Applicant Genesys Spine

K-Number K152099

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FRO 2016-07-28

Atteris Antimicrobial Skin & Wound Cleanser

Applicant Rochal Industries, LLC

K-Number K160192

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MOS 2016-07-28

8ch Foot Ankle Coil

Applicant Shenzhen RF Tech Co., Ltd.

K-Number K160935

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PNS 2016-07-28

Angel Catheter

Applicant Bio2 Medical, Inc.

K-Number K160747

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