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

IYO 2018-04-13

LIGHTSonic BUBM

Applicant Lightmed USA, Inc.

K-Number K170761

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JAK 2018-04-13

SOMATOM go.Up, SOMATOM go.Now, SOMATOM go.Top, SOMATOM go.All, Scan&GO

Applicant Siemens Medical Solutions USA, Inc.

K-Number K173632

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IYN 2018-04-13

SonoSite iViz Ultrasound System

Applicant FUJIFILM Sonosite, Inc.

K-Number K180704

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JAQ 2018-04-13

Best Instruminal Applicator

Applicant Best Medical International, Inc.

K-Number K162499

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MQF 2018-04-13

Pivet and Soft-Pass Embryo Transfer Catheter Sets

Applicant Cook Incorporated

K-Number K173103

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CIX 2018-04-13

ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400

Applicant Biosystems S.A.

K-Number K170901

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HNO 2018-04-13

VisuMax Femtosecond Laser

Applicant Carl Zeiss Meditec, Inc.

K-Number K173371

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LZA 2018-04-13

mCare Powder-free Blue Nitrile Examination Gloves

Applicant Mercator Medical (Thailand), Ltd.

K-Number K172930

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KPS 2018-04-13

uMI 780 PET/CT System

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K172143

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JIN 2018-04-13

KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System

Applicant I-Sens, Inc.

K-Number K170463

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DZI 2018-04-13

Piezosurgery White

Applicant Mectron S.P.A.

K-Number K171326

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OVD 2018-04-13

SeaSpine Vu aPOD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu aPOD Prime Intervertebral Body Fusion Device

Applicant SeaSpine Orthopedics Corporation

K-Number K173606

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