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

JPK 2016-12-22

XN-L CHECK

Applicant Streck

K-Number K160586

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PLV 2016-12-22

Neocis Guidance System

Applicant Neocis, Inc.

K-Number K161399

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MQB 2016-12-21

EVS 4343, EVS 4343G

Applicant DRTECH Corporation

K-Number K162555

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OAT 2016-12-21

Orthodontic Screw

Applicant Osstem Implant Co., Ltd.

K-Number K161197

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KZM 2016-12-21

TEETHAN 2.0

Applicant Bts S.P.A.

K-Number K161716

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FEB 2016-12-21

Scope Buddy Plus Endoscope Flushing Aid

Applicant Medivators, Inc.

K-Number K162128

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JCX 2016-12-21

IntelliCartTM System

Applicant Dornoch Medical Systems

K-Number K162421

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LZA 2016-12-21

Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy Drugs

Applicant Brightway Holdings Sdn. Bhd.

K-Number K161215

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NYL 2016-12-21

EndoVac Pure

Applicant Kerr Corporation

K-Number K162436

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ODP 2016-12-21

IMSE Cervical Cage

Applicant The Institute of Musculoskeletal Science & Education

K-Number K162003

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PQN 2016-12-21

AeroForm Tissue Expander System

Applicant Airxpanders, Inc.

K-Number DEN150055

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EIH 2016-12-21

L- OVC

Applicant Rhondium, Ltd.

K-Number K162677

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