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

LNH 2018-10-19

MAGNETOM Vida

Applicant Siemens Medical Solutions USA, Inc.

K-Number K181433

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LLZ 2018-10-19

UroNav (Version 3.0)

Applicant Invivo Corporation

K-Number K182561

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HRS 2018-10-19

Titanium TomoFix Medial High Tibia Plate Anatomical

Applicant Synthes (USA) Products, LLC

K-Number K180213

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DQK 2018-10-19

EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2

Applicant Abbott

K-Number K182644

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MUA 2018-10-19

EchoS

Applicant Echolight S.P.A

K-Number K180516

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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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