Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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

PON 2016-08-01

Aqueduct 100 Cervical Dilator

Applicant Gtimd, LLC

K-Number K160664

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PEA 2016-08-01

Fuse Endoscopic System with FuseBox Processor

Applicant Endochoice, Inc.

K-Number K160275

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MOS 2016-08-01

8ch Foot Ankle Coil

Applicant Shenzhen RF Tech Co., Ltd.

K-Number K160932

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ODA 2016-08-01

IDSS ForceTriad Control Module

Applicant Black Diamond Video, Inc.

K-Number K153205

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POP 2016-08-01

Nautilus BrainPulse 1000

Applicant Jan Medical, Inc.

K-Number DEN140040

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ITX 2016-08-01

Precision Point Biopsy Needle Guide

Applicant Corbin Clinical Resources, LLC

K-Number K160414

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LLZ 2016-08-01

Senolris

Applicant GE Healthcare

K-Number K160937

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MAX 2016-08-01

SpineView X-Pac Expandable Lumbar Cage System

Applicant Spine View, Inc.

K-Number K160856

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OVE 2016-08-01

Vertu® & Vertu® Ti-Bond and Crystal® & Crystal® Ti-Bond Cervical Interbody System

Applicant Spinal Elements, Inc.

K-Number K153352

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HQD 2016-08-01

SynergEyes SiH with Hydra-PEG(petrafocon A hem-larafilcon A) Hybrid Daily Wear Lens

Applicant Synergeyes, Inc.

K-Number K160938

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PBX 2016-08-01

EndyMed Contour Handpiece

Applicant Endymed Medical, Ltd.

K-Number K161199

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FLL 2016-08-01

Infra-red forehead thermometer

Applicant Hangzhou Hua'An Medical&Health Instruments Co.,Ltd

K-Number K160999

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