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

KWQ 2017-12-06

Boundary Anterior Lumbar Buttress Plate

Applicant Nvision Biomedical Technologies, LLC

K-Number K173091

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NUC 2017-12-06

wettrust D2care

Applicant Wettrust Korea Co., Ltd.

K-Number K170797

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EBF 2017-12-06

BEAUTIFIL Flow Plus X

Applicant Shofu Dental Corporation

K-Number K172530

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MAX 2017-12-06

Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion System

Applicant Nu Vasive, Incorporated

K-Number K173153

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DQY 2017-12-06

091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm

Applicant Inneuroco, Inc.

K-Number K172468

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GDW 2017-12-05

Disposable Circular Stapler

Applicant Changzhou Kangdi Medical Stapler Co., Ltd.

K-Number K172561

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LPL 2017-12-05

OxyPure Color Silicone Hydrogel Soft Contact Lenses

Applicant Visco Vision, Inc.

K-Number K171447

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NKB 2017-12-05

Arisstos™ Spinal System

Applicant Ingenium Spine

K-Number K173126

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GEI 2017-12-05

Vivaer ARC Stylus

Applicant Aerin Medical, Inc.

K-Number K172529

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GCJ 2017-12-05

SYSTEMS INTEGRATION ENDOALPHA MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4 Software Version 1

Applicant Olympus Medical Systems Corp.

K-Number K172618

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IYN 2017-12-05

P20 Series Digital Color Doppler Ultrasound System

Applicant Sonoscape Medical Corp.

K-Number K172993

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EBF 2017-12-05

Renamel Microfill

Applicant Cosmedent, Inc.

K-Number K172707

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