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

LZO 2018-10-22

Quadra P

Applicant Medacta International S.A.

K-Number K181254

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FLL 2018-10-22

TD-1035 Thermometer

Applicant Taidoc Technology Corporation

K-Number K172733

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KIF 2018-10-22

Sonendo Material A

Applicant Sonendo, Inc.

K-Number K181922

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HRS 2018-10-22

ANTHEM Fracture System

Applicant Globus Medical, Inc.

K-Number K180554

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MRC 2018-10-22

Nutrifill

Applicant Contamac, Ltd.

K-Number K181566

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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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