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

MBB 2019-06-09

SpaceFlex Knee

Applicant G21, S.R.L.

K-Number K190216

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KIF 2019-06-07

CeraSeal

Applicant Meta Biomed Co., Ltd.

K-Number K190503

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DRF 2019-06-07

Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable

Applicant Baylis Medical Company, Inc.

K-Number K183632

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QHH 2019-06-07

IB-Stim

Applicant Innovative Health Solutions (Ihs), Inc.

K-Number DEN180057

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ODC 2019-06-07

Andorate Auxiliary Water Connector, Andorate Valves Set

Applicant Smartdata Suzhou Co., Ltd.

K-Number K191231

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FRN 2019-06-07

Ivenix Infusion System (IIS)

Applicant Ivenix, Inc.

K-Number K183311

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MUD 2019-06-07

Masimo O3 Regional Oximeter System

Applicant Masimo Corporation

K-Number K182429

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NGX 2019-06-07

Miha Bodytec II

Applicant Miha Bodytec GmbH

K-Number K182519

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DRF 2019-06-07

Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable

Applicant Baylis Medical Company, Inc.

K-Number K183649

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LRK 2019-06-07

TD Clip

Applicant Zephyr Sleep Technologies, Inc.

K-Number K190051

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ELC 2019-06-07

tün® ultrasonic tips product family

Applicant Engineered Endodontics

K-Number K182145

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HRS 2019-06-07

RIVAL View Plating Systems and Reduce Fracture Plating Systems

Applicant Orthofix Srl

K-Number K190388

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