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

JWH 2018-11-28

Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks

Applicant Smith & Nephew, Inc.

K-Number K183010

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FLL 2018-11-28

Non-contact Infrared Thermometer

Applicant Alicn Medical (Shenzhen), Inc.

K-Number K180207

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PML 2018-11-28

NuVasive Reline Fenestrated Screws, High V+ Bone Cement

Applicant Nu Vasive, Incorporated

K-Number K180498

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OUR 2018-11-27

iFuse Implant System®

Applicant SI-BONE, Inc.

K-Number K182983

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LJM 2018-11-27

EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay

Applicant Phadia AB

K-Number K182353

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HEX 2018-11-27

Biop Digital Colposcope

Applicant Biop Medical , Ltd.

K-Number K182764

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OTM 2018-11-27

AdVance XP Male Sling

Applicant Boston Scientific Corporation

K-Number K182169

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PKR 2018-11-27

gammaCore Sapphire

Applicant Electrocore, Inc.

K-Number K182369

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MAX 2018-11-27

ATEC ALIF and LLIF Spacer System

Applicant Alphatec Spine, Inc.

K-Number K182746

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GEI 2018-11-27

Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator Interconnecting Cable

Applicant Integra LifeSciences Corporation

K-Number K182801

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NXC 2018-11-26

3M Clarity Aligners

Applicant 3M Company

K-Number K183159

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NUH 2018-11-26

Low-frequency Multi-function physiotherapy instrument

Applicant Shenzhen Osto Technology Co., Ltd.

K-Number K172837

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