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

PSZ 2020-04-03

Osom Ultra Plus Flu A&B Test Kit

Applicant SEKISUI Diagnostics, LLC

K-Number K192719

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DZE 2020-04-03

Faico Dental Implant System

Applicant Faico Medical, LLC

K-Number K192015

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MAX 2020-04-02

SIRION Lateral Lumbar Interbody System

Applicant Astura Medical, LLC

K-Number K192006

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JOJ 2020-04-02

QwikCheck Chemical Indicators

Applicant Serim Research Corporation

K-Number K192445

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GEI 2020-04-02

ARC 400

Applicant Bowa-Electronics GmbH & Co. KG

K-Number K193591

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KNW 2020-04-02

MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy and Aspiration System, MED-B Bone Marrow Biopsy System, MED-J Bone Marrow Biopsy and Aspiration System

Applicant Medax Srl Unipersonale

K-Number K192099

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DQY 2020-04-02

NovaCross CTO Microcatheter

Applicant Nitiloop , Ltd.

K-Number K193322

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LLZ 2020-04-02

IntelePACS

Applicant Intelerad Medical Systems Incorporated

K-Number K192176

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FAJ 2020-04-02

Ambu aScope 4 Cysto

Applicant Ambu A/S

K-Number K193095

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NKG 2020-04-02

SYMPHONY OCT System

Applicant Medos International SARL

K-Number K192646

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FMT 2020-04-02

HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable

Applicant Deroyal Industries, Inc.

K-Number K200319

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MHX 2020-04-02

Patient Monitor

Applicant Edan Instruments, Inc.

K-Number K192514

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