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

POM 2018-10-20

ImPACT

Applicant Impact Applications, Inc.

K-Number K181223

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NPM 2018-10-19

Straumann cerabone

Applicant Institut Straumann AG

K-Number K173594

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MOS 2018-10-19

1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, 1.5T 30ch AIR AA

Applicant GE Healthcare

K-Number K182590

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LNH 2018-10-19

Vantage Orian 1.5T, MRT-1550, V4.5

Applicant Canon Medical Systems Corporation

K-Number K182282

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DBL 2018-10-19

Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts

Applicant Immuno Concepts, N.A. , Ltd.

K-Number K180202

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OMP 2018-10-19

AVELLE Negative Pressure Wound Therapy System

Applicant Convatec Limited

K-Number K180205

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MSB 2018-10-19

Paragonix SherpaPak Cardiac Transport System

Applicant Paragonix Technologies

K-Number K182735

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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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