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

KLW 2018-07-13

Tinnitus Sound Generator Module

Applicant GN Hearing A/S

K-Number K181586

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LFD 2018-07-13

G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry Mouth Oral Spray

Applicant Sunstar Americas, Inc.

K-Number K181134

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PIF 2018-07-12

CONOD Enteral Feeding Sets

Applicant Conod Medical Co., Limited

K-Number K181276

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GEI 2018-07-12

THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type X

Applicant Olympus Medical Systems Corp.

K-Number K180575

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FLL 2018-07-12

Infrared Thermometer

Applicant Shenzhen Jiacom Technology CO ., Ltd.

K-Number K172874

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EBF 2018-07-12

Estelite Universal Flow

Applicant Tokuyama Dental Corporation

K-Number K180613

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ELW 2018-07-12

AIM2

Applicant GC America, Inc.

K-Number K181011

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NLQ 2018-07-12

Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector

Applicant Surgical Instrument Service and Savings, Inc.

K-Number K173627

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OVD 2018-07-12

FBC 921 (ALIF)

Applicant Fbc Device Aps

K-Number K180695

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PDJ 2018-07-12

SEKURE HbA1c Assay

Applicant Sekisui Diagnostics P.E.I., Inc.

K-Number K173206

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NBW 2018-07-12

ActiveCare TD-4121 Blood Glucose Monitoring System

Applicant Taidoc Technology Corporation

K-Number K173511

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KWT 2018-07-12

Catalyst CSR Shoulder System

Applicant Catalyst Orthoscience, Inc.

K-Number K181287

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