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

DRG 2016-06-03

LifeStream Management System, LifeStream Management Suite, LifeStream Patient Manager, LifeStream Manager, LifeStream Web Manager, LifeStream

Applicant Honeywell Hommed, LLC

K-Number K153719

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MBI 2016-06-03

OrthoButton CL

Applicant Riverpoint Medical

K-Number K160655

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FMF 2016-06-03

HumaPen Savvio

Applicant Eli Lilly and Company, Inc.

K-Number K160668

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ELC 2016-06-03

Sonendo GentleWave System

Applicant Sonendo, Inc.

K-Number K160905

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GGN 2016-06-03

VALIDATE D-Dimer Calibration Verification/Linearity Test Kit

Applicant Maine Standards Company, LLC

K-Number K152961

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OUR 2016-06-03

iFUSE Implant System

Applicant SI-BONE, Inc.

K-Number K160652

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GAM 2016-06-03

Coated VICRYU (Polyglactin 91O)Sterile Synthetic Absorbable Suture Cartridges, ETHIBOND Polybutilate Coated Polyester Sterile Synthetic Non-Absorbable Suture Cartridges, PROXISURE Suturing Device

Applicant Ethicon, LLC

K-Number K153611

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PDZ 2016-06-03

LunulaLaser

Applicant Erchonia Medical, Inc.

K-Number K153164

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GZJ 2016-06-03

Strive

Applicant Djo, LLC

K-Number K153704

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FXX 2016-06-03

Communicator Surgical Facemask with Clear Window

Applicant Prestige Ameritech , Ltd.

K-Number K152561

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NUH 2016-06-03

Heat Pain Pro

Applicant Omron Healthcare, Inc.

K-Number K160115

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DYB 2016-06-03

Halo One Thin-Walled Guiding Sheath

Applicant C.R. Bard, Inc.

K-Number K161183

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