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

PCI 2017-07-12

Great Basin Stool Bacterial Pathogens Panel

Applicant Great Basin Scientific, Inc.

K-Number K163571

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PLQ 2017-07-12

Relizorb

Applicant Alcresta Therapeutics, Inc.

K-Number K163057

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IYE 2017-07-12

TrueBeam, TrueBeam STx, Edge

Applicant Varian Medical Systems, Inc.

K-Number K171733

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IYN 2017-07-11

P60 Series Digital Color Doppler Ultrasound System

Applicant Sonoscape Medical Corp.

K-Number K171000

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MAX 2017-07-11

EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellular Titanium ALIF Cages

Applicant Eit Emerging Implant Technologies GmbH

K-Number K170503

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DXE 2017-07-11

Needle's Eye Snare Retrieval Set - 54cm

Applicant Cook Incorporated

K-Number K163353

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OLO 2017-07-11

OrthAlign Plus System

Applicant Orthalign, Inc.

K-Number K171780

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GZI 2017-07-11

RT300 FES cycle ergometer

Applicant Restorative Therapies, Inc.

K-Number K162470

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CHH 2017-07-11

Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System

Applicant ACON Laboratories, Inc.

K-Number K163406

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CIG 2017-07-11

ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1

Applicant Elitechgroup

K-Number K171401

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LRK 2017-07-11

O2Vent W

Applicant Oventus Manufacturing Pty, Ltd.

K-Number K171316

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IYE 2017-07-11

Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and Accessories

Applicant Qfix

K-Number K171133

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