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

DQD 2017-05-19

Eko Model E5 System (EME5), Eko DUO

Applicant Eko Devices, Inc.

K-Number K170874

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PUQ 2017-05-19

BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set

Applicant Bio-Rad Laboratories

K-Number K170509

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OOE 2017-05-19

Catalys Precision Laser System

Applicant Abbott Medical Optics, Inc.

K-Number K170322

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HBW 2017-05-19

Stryker Universal Neuro III System AXS Screw

Applicant Stryker

K-Number K171152

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GEI 2017-05-19

PK AIM

Applicant Gyrus Acmi, Inc.

K-Number K170908

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OMA 2017-05-19

Nihon Kohden QP-160AK EEG Trend Program

Applicant Nihon Kohden Corporation

K-Number K163644

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OWB 2017-05-19

OEC Elite

Applicant Oec Medical Systems, Inc.

K-Number K170752

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MAX 2017-05-19

DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K162212

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HBE 2017-05-19

OsteoMed PINNACLE Driver

Applicant Osteomed

K-Number K162542

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IYN 2017-05-19

E5 Series Digital Color Doppler Ultrasound System

Applicant Sonoscape Medical Corp.

K-Number K170303

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JKA 2017-05-19

Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder

Applicant Sol-Millennium Medical, Inc.

K-Number K163073

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PGW 2017-05-19

StealthStationTM S8 ENT Software

Applicant Medtronic Navigation, Inc.

K-Number K170018

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