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

OAS 2019-09-20

SeeFactorCT3

Applicant Epica International, Inc.

K-Number K190856

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NFW 2019-09-20

BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip

Applicant Shenzhen Bioeasy Biotechnology Co., Ltd.

K-Number K192301

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NQW 2019-09-20

Hinged Laminoplasty System

Applicant Life Spine, Inc.

K-Number K191927

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FRO 2019-09-20

Clyra Wound Irrigation Solution

Applicant Clyra Medical Technologies, Inc.

K-Number K181428

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LLZ 2019-09-20

Merge Cardio

Applicant Merge Healthcare Incorporated

K-Number K192276

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QFG 2019-09-20

Omnipod DASH Insulin Management System with interoperable technology

Applicant Insulet Corporation

K-Number K191679

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QEW 2019-09-20

ClotTriever Thrombectormy System, ClotTriever Catheter, ClotTriever Sheath

Applicant Inari Medical

K-Number K192332

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DQY 2019-09-20

Medtronic 6F Taiga Guiding Catheter

Applicant Medtronic Vascular

K-Number K192296

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FOZ 2019-09-20

Supercath 5

Applicant Togo Medikit Co., Ltd.

K-Number K190001

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PSY 2019-09-20

Philips IntelliSite Pathology Solution

Applicant Philips Electronics Nederland B.V.

K-Number K192259

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JAK 2019-09-20

syngo.CT Extended Functionality

Applicant Siemens Medical Solutions USA, Inc.

K-Number K192402

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LOX 2019-09-19

Sapphire NC Plus Coronary Dilatation Catheter

Applicant Orbusneich Medical Trading, Inc.

K-Number K192344

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