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

PMT 2018-07-16

Atellica IM BRAHMS Procalcitonin (PCT)

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K181002

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DXJ 2018-07-16

Philips IntelliVue GuardianSoftware

Applicant Philips Medizin Systeme Boeblingen GmbH

K-Number K180534

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GEX 2018-07-16

Diode Laser System

Applicant Guangzhou Huafei Tongda Technology Co., Ltd.

K-Number K181019

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OUR 2018-07-16

PathLoc-SI Joint Fusion System

Applicant L&K BIOMED Co., Ltd.

K-Number K181600

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MYC 2018-07-16

EIDON FA

Applicant Centervue S.P.A.

K-Number K180526

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ODP 2018-07-16

CxHA PEEK Cervical IBF System

Applicant Innovasis, Inc.

K-Number K181115

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KRD 2018-07-16

Embosphere Microspheres

Applicant Biosphere Medical, S.A.

K-Number K181300

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PZS 2018-07-16

MC3 Jugular Dual Lumen Catheter

Applicant Mc3 Incorporated

K-Number K180151

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NFJ 2018-07-16

Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System

Applicant Welch Allyn, Inc.

K-Number K181016

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OZZ 2018-07-15

Solana Bordetella Complete Assay

Applicant Quidel Corporation

K-Number K181029

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MQB 2018-07-13

Aquarius 8600 Digital Radiography Sensor

Applicant Biokinemetrics, Inc.

K-Number K181565

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JXG 2018-07-13

IRRAflow CNS System

Applicant Irras, Inc.

K-Number K171880

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