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

EJR 2017-09-11

AIR-FLOW PLUS Prophylaxis powder

Applicant E.M.S Electro Medical Systems S.A

K-Number K171189

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NAY 2017-09-11

da Vinci Xi EndoWrist Instruments and Accessories

Applicant Intuitive Surgical, Inc.

K-Number K170645

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KNT 2017-09-11

Navina Classic System

Applicant Dentsply Sirona

K-Number K170487

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NBL 2017-09-11

Electronic Caries Detector

Applicant Ortek Therapeutics, Inc.

K-Number K170822

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NAY 2017-09-11

da Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE Curved Shears (5mm & 8mm)

Applicant Intuitive Surgical, Inc.

K-Number K170644

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LYZ 2017-09-11

Clear Vinyl Powder-free Patient Examination Gloves

Applicant Shandong Zhi Hong Medical Products, Co. , Ltd.

K-Number K171317

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GWO 2017-09-11

Sterile NS System

Applicant Jeil Medical Corporation

K-Number K170368

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EKX 2017-09-11

Tri Auto ZX2

Applicant J. Morita USA, Inc.

K-Number K170275

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ELB 2017-09-11

TN-Brush

Applicant Genoss Co., Ltd.

K-Number K170596

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KNW 2017-09-11

Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle

Applicant Care Fusion

K-Number K171531

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DYB 2017-09-11

Prelude Pursuit Splittable Sheath Introducer

Applicant Merit Medical Systems, Inc.

K-Number K172117

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HSN 2017-09-11

INVISION Total Ankle Revision System

Applicant Wrightmedicaltechnologyinc

K-Number K171067

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