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

PRI 2018-07-06

Elecsys BRAHMS PCT

Applicant Roche Diagnostics

K-Number K173927

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DIO 2018-07-06

DRI Cocaine Metabolite Assay

Applicant Microgenics Corporation

K-Number K181499

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JSO 2018-07-06

CHROMID CARBA agar (CARB)

Applicant Biomerieux S.A.

K-Number K181092

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OCX 2018-07-06

Endorate Valve Sets

Applicant Smartdata Suzhou Co., Ltd.

K-Number K181509

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FGE 2018-07-06

Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary Drainage Set, Leung Nasal Biliary Drainage Set

Applicant Cook Ireland

K-Number K180868

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LZO 2018-07-06

BIOLOX delta Option and Extra-long Heads

Applicant Microport Orthopedics, Inc.

K-Number K173776

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GCA 2018-07-06

Howell D.A.S.H Extraction Balloon with Multiple Sizing

Applicant Wilson-Cook Medical, Inc.

K-Number K173659

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NKG 2018-07-06

ASTRA-OCT Spine System

Applicant Spinecraft, LLC

K-Number K181350

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NDC 2018-07-06

InPen Dose Calculator

Applicant Companion Medical, Inc.

K-Number K181327

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KWQ 2018-07-06

Vail ALIF Buttress Plate System

Applicant Evolution Spine, LLC

K-Number K180755

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NKB 2018-07-06

OLYMPIC Posterior Spinal Fixation System

Applicant Astura Medical, LLC

K-Number K181139

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GEX 2018-07-05

Fractional CO2 Surgical Laser System

Applicant Ami, Inc.

K-Number K173359

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