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

OVD 2017-09-07

T-Rex Standalone ALIF

Applicant Siats, LLC

K-Number K170855

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LLZ 2017-09-07

NeuroQuant

Applicant Cortechs Labs, Inc.

K-Number K170981

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GEI 2017-09-07

Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini

Applicant Medtronic Advanced Energy

K-Number K170381

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ODP 2017-09-07

Reliance Cervical IBF System

Applicant Reliance Medical Systems, LLC

K-Number K172489

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NUC 2017-09-07

FuckWater

Applicant Non-Friction Products, Inc.

K-Number K171730

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HWC 2017-09-07

S4 Screw System

Applicant Subchondral Solutions

K-Number K162171

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KRD 2017-09-06

QuadraSphere Microspheres

Applicant Biosphere Medical, S.A.

K-Number K172372

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ODP 2017-09-06

Tritanium C Anterior Cervical Cage

Applicant Stryker Spine

K-Number K171496

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HGM 2017-09-06

Central Monitoring System

Applicant Edan Instruments, Inc.

K-Number K171178

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CAF 2017-09-06

The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS)

Applicant Shenzhen Homed Medical Device Co., Ltd.

K-Number K161586

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DZE 2017-09-06

Dentis Dental Implant System

Applicant Dentis Co., Ltd.

K-Number K171027

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NBS 2017-09-06

QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls

Applicant Inova Diagnostics, Inc.

K-Number K163538

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