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

DWF 2018-10-19

DLP Aortic Root Cannula, DLP Aortic Root Cannula with Vent Line, DLP Pressure Monitoring Extension Line Adapter, DLP Cardioplegia Adapter with Pressure Port

Applicant Medtronic, Inc.

K-Number K182586

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MBI 2018-10-19

ICONN Revolution Knotless Suture Anchor

Applicant Iconn Orthopedics, LLC

K-Number K182264

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OVE 2018-10-19

Stable-C Interbody System

Applicant Nexus Spine, LLC

K-Number K181621

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IYN 2018-10-19

Vivid S60N, Vivid S70N

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K-Number K182450

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OBO 2018-10-18

Spectralis HRA+OCT and variants with High Magnification Module

Applicant Heidelberg Engineering GmbH

K-Number K182569

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FPA 2018-10-18

BD FlowSmart Set/MiniMed Pro-Set

Applicant Becton, Dickinson and Company

K-Number K181718

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NLH 2018-10-18

Reprocessed Torqr Diagnostic EP Catheter

Applicant Innovative Health, LLC

K-Number K181618

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KNW 2018-10-18

Medax Biopsy Systems III

Applicant Medax Srl Unipersonale

K-Number K181803

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DTX 2018-10-18

Quantum Ventilation Module

Applicant Spectrum Medical , Ltd.

K-Number K181942

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CHH 2018-10-18

Extended Lipid Panel Assay

Applicant Laboratory Corporation of America Holdings

K-Number K181373

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PIF 2018-10-18

Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube with ENFit Connection, Entuit LP Patient Care Kit, Entuit LP Patient Care Kit with ENFit Connection, PromaX Low Profile Gastrostomy Feeding Tube, PromaX LP Patient Care Kit with ENFit

Applicant Xeridiem Medical Devices, A Spectrum Plastics Group Company

K-Number K180708

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NKB 2018-10-18

OLYMPIC Posterior Spinal Fixation System

Applicant Astura Medical, LLC

K-Number K182239

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