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

HWC 2018-10-26

Two-Step Implant System

Applicant Trilliant Surgical

K-Number K181898

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NUH 2018-10-26

V2 OTC Pain Relief TENS

Applicant Everyway Medical Instruments Co.,Ltd

K-Number K182767

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LLZ 2018-10-26

Implant Planning Software

Applicant Inteware Co., Ltd.

K-Number K173965

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DZE 2018-10-26

Biomate Dental Implant System

Applicant Biomate Medical Devices Technology Co., Ltd.

K-Number K170732

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FDF 2018-10-26

PENTAX Medical Video Colonoscope EC34-i10T Series

Applicant Pentax Medical of America, Inc.

K-Number K180285

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DYB 2018-10-26

TSI Transseptal Introducer

Applicant Pressure Products Medical Device Manufacturing, LLC

K-Number K181031

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QDK 2018-10-26

Dexcom G6 Glucose Program Continuous Glucose Monitoring System

Applicant Dexcom, Inc.

K-Number K182041

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NUH 2018-10-26

A6 OTC Pain Relief TENS

Applicant Everyway Medical Instruments Co.,Ltd

K-Number K182753

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OAP 2018-10-26

Hair Laser Headband

Applicant Pulsaderm, LLC

K-Number K182501

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QBC 2018-10-25

External upper limb tremor stimulator

Applicant Cala Health, Inc.

K-Number K182706

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GBM 2018-10-25

SpeediCath Standard

Applicant Coloplast

K-Number K180258

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JXG 2018-10-25

Codman Certas Plus Electronic Tool Kit

Applicant Integra Lifesciences Corp.

K-Number K181902

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