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

HIS 2016-08-26

Trojan XOXO Thin Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant

Applicant Church & Dwight Co., Inc.

K-Number K161545

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FXX 2016-08-26

Skypro, SP01 Mask

Applicant Skypro Medical Supplies Company

K-Number K152197

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GEX 2016-08-26

ORION

Applicant Yerim Engineering Co., Ltd.

K-Number K161503

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IMG 2016-08-26

OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System

Applicant Accelerated Care Plus (Acp)

K-Number K153559

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IYN 2016-08-26

RS80A Diagnostic Ultrasound System

Applicant Samsung Medison Co., Ltd.

K-Number K162094

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NHA 2016-08-26

GPS Angled Abutment

Applicant Implant Direct Sybron Manufacturing, LLC

K-Number K153509

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LPL 2016-08-26

EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear

Applicant Vision Science Co., Ltd.

K-Number K161124

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IRT 2016-08-26

Bite Away

Applicant Riemser Pharma

K-Number K160943

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DZE 2016-08-26

LUNA DENTAL IMPLANT SYSTEM

Applicant Shinhung Mst Co., Ltd.

K-Number K160106

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GZB 2016-08-26

Freedom Spinal Cord Stimulator System

Applicant Stimwave Technologies Incorporated

K-Number K160600

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DYW 2016-08-26

CompleClear Plastic Orthodontic Bracket and Wire Appliance

Applicant Oracrew

K-Number K150830

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OTJ 2016-08-26

FMX314 Surgical Platform

Applicant Fortimedix Surgical B.V.

K-Number K160797

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