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

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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JWH 2019-09-05

Freedom Primary PCK

Applicant Maxx Orthopedics, Inc.

K-Number K192148

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QEW 2019-09-05

FlowTriever Retrieval/Aspiration System

Applicant Inari Medical

K-Number K191710

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QBO 2019-09-04

Cartiva SCI instrumentation set

Applicant Cartiva, Inc.

K-Number K192156

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GXY 2019-09-04

Myo Plus

Applicant Otto Bock Healthcare Products GmbH

K-Number K191179

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OWB 2019-09-04

MobileRay Pulse SE Digital Imaging System

Applicant Portavision Medical, LLC

K-Number K191503

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IWB 2019-09-04

Akesis Galaxy

Applicant Akesis, Inc.

K-Number K190844

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EIA 2019-09-04

K3

Applicant Osstem Implant Co., Ltd.

K-Number K183347

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HRX 2019-09-04

Smith & Nephew DYONICS 25 Fluid Management System

Applicant Smith & Nephew, Inc.

K-Number K192155

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