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

KPS 2017-11-21

Hybrid3D

Applicant Hermes Medical Solutions AB

K-Number K171719

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ELC 2017-11-21

Ultrasonic scaler

Applicant Nanning VV Dental Co., Ltd.

K-Number K163414

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KLE 2017-11-21

Parkell Universal Adhesive

Applicant Parkell, Inc.

K-Number K172176

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KPS 2017-11-21

Hermes Medical Imaging Suite v5.7

Applicant Hermes Medical Solutions AB

K-Number K171681

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LLZ 2017-11-21

MIM – Y90 Dosimetry

Applicant Mim Software, Inc.

K-Number K172218

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GEH 2017-11-21

Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel

Applicant Galil Medical, Inc.

K-Number K173037

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ODP 2017-11-21

Vertera Spine Cohere Cervical Interbody Fusion Device

Applicant Nu Vasive, Incorporated

K-Number K173030

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DQY 2017-11-21

TXM Support Catheter

Applicant Texasmedical Technologies, Inc.

K-Number K170914

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LCP 2017-11-21

Alere Afinion HbA1c and ACR on Afinion 2 analyzer

Applicant Abbott Rapid Diagnostics

K-Number K171650

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KMW 2017-11-21

Surgical Angle Handpiece, Surgical Straight Handpiece

Applicant Nakanishi, Inc.

K-Number K171155

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JEY 2017-11-21

KLS Martin Individual Patient Solutions

Applicant KLS Martin L.P.

K-Number K163579

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NUC 2017-11-21

Climax Personal Lubricant

Applicant Wsm Investment, LLC, Dba Topco Sales

K-Number K171044

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