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

IYN 2018-12-04

HS50 / HS60 Diagnostic Ultrasound System

Applicant Samsung Medison Co., Ltd.

K-Number K181336

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LKN 2018-12-04

AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter

Applicant Fresenius Kabi USA,Llc

K-Number K180615

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LLZ 2018-12-04

CAAS MR Solutions

Applicant Pie Medical Imaging BV

K-Number K181825

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OCL 2018-12-04

Coolrail Linear Pen

Applicant AtriCure, Inc.

K-Number K183065

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MAX 2018-12-04

MectaLIF Posterior Extension

Applicant Medacta International S.A.

K-Number K181970

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MUJ 2018-12-04

Monaco RTP System

Applicant Elekta, Inc.

K-Number K183037

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FTL 2018-12-04

Endoform Reconstructive Template - Non Absorbable

Applicant Aroa Biosurgery , Ltd.

K-Number K181935

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IYE 2018-12-04

Elekta Unity

Applicant Elekta Limited

K-Number K182076

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HCG 2018-12-04

Spartan eCoil System

Applicant Spartan Micro, Inc.

K-Number K180653

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LLZ 2018-12-03

IMPLANTER DENTAL PLANNING SOFTWARE

Applicant Implanter, LLC

K-Number K173083

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ITI 2018-12-03

Action Trackchair

Applicant Action Manufacturing, Inc.

K-Number K181908

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DJG 2018-12-03

LZI Fentanyl Enzyme Immunoassay

Applicant Lin-Zhi International, Inc.

K-Number K181159

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