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 2018-10-04

WishBone Medical Plate and Screw System

Applicant Wishbone Medical, Inc.

K-Number K180736

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EOB 2018-10-04

Rhino-Laryngo Fiberscope Olympus ENF-GP2

Applicant Olympus Medical Systems Corp.

K-Number K181240

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MQB 2018-10-04

PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels

Applicant Pixxgen Corporation

K-Number K182533

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NOZ 2018-10-04

Diazyme 1,5-AG Assay

Applicant Diazyme Laboratories, Inc.

K-Number K180209

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NKG 2018-10-04

SYMPHONY OCT System

Applicant Medos International SARL

K-Number K181949

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IYE 2018-10-04

Encompass SRS Headframe ; Encompass MR SRS Headframe

Applicant Qfix

K-Number K182189

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HBE 2018-10-04

POWEREASE System

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K182436

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HRS 2018-10-03

ARIX Clavicle System

Applicant Jeil Medical Corporation

K-Number K180972

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JAQ 2018-10-03

BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes, and Length Assessment Device

Applicant Varian Medical Systems, Inc.

K-Number K181903

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PGY 2018-10-03

2MP Color LCD Monitor CL-R211

Applicant Jvckenwood Corporation

K-Number K182539

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DZE 2018-10-03

IS-III active System

Applicant Neobiotech Co., Ltd.

K-Number K181138

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NBW 2018-10-03

On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System

Applicant ACON Laboratories, Inc.

K-Number K181527

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