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

NQW 2017-07-14

HAVEN Laminoplasty System, CANOPY® Laminoplasty Fixation System

Applicant Globus Medical, Inc.

K-Number K171413

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MQF 2017-07-14

Soules Intrauterine Insemination Catheter

Applicant Cook Incorporated

K-Number K163318

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IKN 2017-07-14

ViMove2

Applicant Dorsavi, Ltd.

K-Number K163150

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GEH 2017-07-14

truFreeze Rapid AV Spray Kit

Applicant CSA Medical, Inc.

K-Number K171522

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LZA 2017-07-14

Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy Drugs

Applicant Brightway Holdings Sdn. Bhd.

K-Number K170686

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PBX 2017-07-14

sensiFirm

Applicant El Global Trade, Ltd.

K-Number K170637

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ODP 2017-07-13

Coveris Cervical Cage System

Applicant Camber Spine Technologies

K-Number K170550

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MQF 2017-07-13

Kitazato ET Catheters

Applicant Kitazato Corporation

K-Number K162878

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JWH 2017-07-13

Unity Total Knee System

Applicant Corin U.S.A. Limited

K-Number K170808

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NKB 2017-07-13

OpenLoc-L Spinal Fixation System, LnK Spinal Fixation System

Applicant L&K BIOMED Co., Ltd.

K-Number K171813

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KCT 2017-07-13

SterilContainer S System

Applicant Aesculap, Inc.

K-Number K162815

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MAX 2017-07-13

HD Lumbar Interbody System

Applicant Hd Lifesciences, LLC

K-Number K170676

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