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

GBM 2017-11-22

Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent

Applicant Cook Incorporated

K-Number K172278

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OLO 2017-11-22

OrthAlign Plus System

Applicant Orthalign, Inc.

K-Number K172462

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OWB 2017-11-22

Azurion series R1.2

Applicant Philips Medical Systems Nederland B.V.

K-Number K172822

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PIE 2017-11-22

EsoFLIP® ES-310 Balloon Catheter

Applicant Crospon, Ltd.

K-Number K172128

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NTK 2017-11-22

CamX Triton HD Proxi Head

Applicant Duerr Dental AG

K-Number K172007

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PLC 2017-11-22

Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder

Applicant Prosomnous Sleep Technologies

K-Number K172859

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OZN 2017-11-22

GenePOC CDiff

Applicant Genepoc, Inc.

K-Number K172569

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PZY 2017-11-22

DENTCA DENTURE Teeth

Applicant Dentca, Inc.

K-Number K172398

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DZE 2017-11-22

BioHorizons Tapered Short Implants

Applicant BioHorizons Implant Systems, Inc.

K-Number K172576

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FLL 2017-11-22

Non Contact Infrared Forehead Thermometer

Applicant Intrinity Global Limited

K-Number K170662

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DXN 2017-11-22

The Wrist-Type Fully Automatic Digital Blood Pressure Monitors

Applicant Joytech Healthcare Co. , Ltd.

K-Number K170666

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MXA 2017-11-22

NIOX VERO

Applicant Circassia AB

K-Number K170983

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