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

OCU 2019-05-07

Scope ProTech

Applicant Meditech Endoscopy, Ltd.

K-Number K191011

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FDF 2019-05-07

FUJIFILM Endoscope Model EC-760S-V/L

Applicant Fujifilm Corporation

K-Number K190649

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FMI 2019-05-07

SteriCap Mini Needle

Applicant Ocujet, LLC

K-Number K183016

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MLY 2019-05-07

Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chloride Mist, Ethyl Chloride Accustream 360* Medium Spray, Ethyl Chloride Accustream 360* Fine Spray

Applicant Gebauer Company

K-Number K190161

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JIL 2019-05-07

cobas u 601 urinalysis test system

Applicant Roche Diagnostics

K-Number K183432

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KCT 2019-05-07

Stryker ChestShield Sterilization Tray System

Applicant Paragon Medical

K-Number K183701

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DZL 2019-05-07

OssBuilder System

Applicant Osstem Implant Co., Ltd.

K-Number K181854

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KCT 2019-05-07

Neodent Instruments Kits

Applicant Jjgc Industria E Comercio DE Materiais Dentarios S.A.

K-Number K182865

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KPS 2019-05-06

Biograph Vision

Applicant Siemens Medical Solutions USA, Inc.

K-Number K190900

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FRN 2019-05-06

Unity Subcutaneous Delivery System for Remodulin

Applicant DEKA Research & Development

K-Number K190182

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QFM 2019-05-06

HealthPNX

Applicant Zebra Medical Vision, Ltd.

K-Number K190362

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IYO 2019-05-06

MD-6000P Bladder Scanner

Applicant MEDA Co., Ltd.

K-Number K182460

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