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

LIT 2016-01-22

Crosperio RX PTA Balloon Dilatation Catheter

Applicant KANEKA Corporation

K-Number K152887

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GZJ 2016-01-22

FD TENS 2090, FD TENS 2095

Applicant Fuji Dynamics , Ltd.

K-Number K152676

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GCJ 2016-01-22

VersaOne Bladed Trocar 5mm

Applicant Covidien

K-Number K152149

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CAF 2016-01-22

POCKET NEB

Applicant Microvaper Devices

K-Number K142541

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GCJ 2016-01-22

General & Plastic Surgery Instruments

Applicant Sontec Instruments, Inc.

K-Number K152400

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BSP 2016-01-22

Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit

Applicant Solo-Dex, Inc.

K-Number K151072

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GEI 2016-01-22

Stryker Neptune E-SEP Smoke Evacuation Pencil

Applicant Stryker Corporation

K-Number K153679

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LIT 2016-01-22

Crosstella RX Balloon Dilatation Catheter

Applicant KANEKA Corporation

K-Number K152873

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EIA 2016-01-22

Evogue Dental Unit

Applicant Takara Belmont Corporation

K-Number K152100

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IZQ 2016-01-22

CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set

Applicant Bracco Injeneering

K-Number K151048

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LZO 2016-01-21

Corin Metafix Hip Stem

Applicant Corin U.S.A. Limited

K-Number K153381

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NQW 2016-01-21

Release Laminoplasty Fixation System

Applicant Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)

K-Number K153735

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