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

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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DRG 2018-10-03

Caretaker Remote Display App and Caretaker Software Library

Applicant Caretaker Medical, LLC

K-Number K181196

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LNH 2018-10-03

uMR 790

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K181371

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PQC 2018-10-03

FIREFLY® Midline Navigation Guide

Applicant Mighty Oak Medical, Inc.

K-Number K181883

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OUR 2018-10-03

Outlet Sacroiliac Joint Fusion System

Applicant Sij Surgical

K-Number K181881

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IYE 2018-10-03

Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy Therapist v4.3.1_MR3 Patch, syngo Radiation Therapy Oncologist v4.3.1_MR3 Patch

Applicant Siemens Medical Solutions USA, Inc.

K-Number K182050

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LNH 2018-10-03

uMR 780

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K181370

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