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

HRS 2018-11-16

AdvantageRib Anterior System

Applicant Sig Medical Corp.

K-Number K182179

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DWF 2018-11-16

PureFlex Arterial Cannulae

Applicant Sorin Group Italia S.R.L.

K-Number K180979

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OLV 2018-11-16

Serenity Piezo Sensor, Serenity Thermocouple Sensor

Applicant Neurotronics, Inc.

K-Number K181709

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OAP 2018-11-16

Hair Boom 69

Applicant Wontech

K-Number K182562

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DZE 2018-11-16

IT-III active System

Applicant Neobiotech Co., Ltd.

K-Number K181137

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QDT 2018-11-16

AposTherapy System

Applicant Apos Medical Assets , Ltd.

K-Number K182090

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DQK 2018-11-16

HemoSphere Advanced Monitor, HemoSphere Pressure Cable

Applicant Edwards Lifesciences, LLC

K-Number K180881

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LRK 2018-11-16

Oral Device OA, Oral Device S

Applicant Passion For Life Healthcare (Uk) Limited

K-Number K181396

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MQP 2018-11-16

Solidity Vertebral Body Replacement

Applicant Ulrich Medical USA

K-Number K181921

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KCT 2018-11-16

InstruSafe(R) Sterilization Container

Applicant Summit Medical, Inc.

K-Number K180528

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MOS 2018-11-16

1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil

Applicant Rapid Biomedical GmbH

K-Number K181948

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NHA 2018-11-16

Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant System

Applicant Dentalpoint AG

K-Number K180184

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