Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

PKQ 2017-01-13

Cantab Mobile

Applicant Cambridge Cognition , Ltd., US Agent: Clementi Associates , Ltd.

K-Number K161328

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OHS 2017-01-13

RED Light Device

Applicant Zhongshan Bisen Plastic Electronic Products Co., Ltd.

K-Number K162489

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JIT 2017-01-13

Lumipulse G FSH-N Calibrators

Applicant Fujirebio Diagnostics,Inc.

K-Number K163534

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MVL 2017-01-13

GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord

Applicant Kerr Corporation

K-Number K162164

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GXP 2017-01-13

OsteoVation Impact

Applicant Skeletal Kinetics, LLC

K-Number K162864

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HIS 2017-01-13

LELO RESPECT HEX Natural Rubber Latex Condom

Applicant Lelo, Inc.

K-Number K162511

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NPL 2017-01-13

DynaMatrix/Dynamatrix Plus

Applicant Cook Biotech Incorporated

K-Number K161762

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PBY 2017-01-13

Magseed Magnetic Marker System

Applicant Endomagnetics Ltd.,

K-Number K163541

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DZE 2017-01-13

SuperLine

Applicant Dentium Co., Ltd.

K-Number K160965

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EHD 2017-01-13

RX DC

Applicant Cefla S.C.

K-Number K163519

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HHT 2017-01-13

Kolplast Cervical Sample Collection Kit

Applicant Kolplast CI SA

K-Number K153128

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JWH 2017-01-13

Legion Cone System

Applicant Smith & Nephew, Inc.

K-Number K162775

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