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

FMI 2019-09-05

Dual-Safety Pen Needle

Applicant Promisemed Hangzhou Meditech Co., Ltd.

K-Number K191853

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GEX 2019-09-05

Holinwon 30

Applicant Wontech Co., Ltd.

K-Number K183563

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FLL 2019-09-05

Advocate Non-Contact Infrared Thermometer

Applicant Broadmaster Biotech, Corp.

K-Number K191004

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MQL 2019-09-05

GM501 Wash

Applicant Hamilton Thorne, Inc.

K-Number K190383

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EBG 2019-09-05

SmarTemp X1

Applicant Parkell, Inc.

K-Number K190930

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JWH 2019-09-05

Persona Revision Knee System

Applicant Zimmer, Inc.

K-Number K191625

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NXC 2019-09-05

3M Clarity Aligners

Applicant 3M Company

K-Number K192119

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MED 2019-09-05

SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900

Applicant STERIS Corporation

K-Number K191343

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LBI 2019-09-05

bili-hut

Applicant Little Sparrows Technologies, Inc.

K-Number K190899

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ODG 2019-09-05

FUJIFILM Ultrasonic Endoscope

Applicant Fujifilm Corporation

K-Number K183433

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EOQ 2019-09-05

EVIS EXERA III Bronchovideoscope Olympus BF-XT190

Applicant Olympus Medical Systems Corp.

K-Number K183419

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LCX 2019-09-05

HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream

Applicant Qingdao Hightop Biotech Co., Ltd.

K-Number K192123

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