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

IMJ 2018-05-01

ViaTherm BOOST

Applicant Viatherm Therapeutics, LLC

K-Number K173300

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GEI 2018-05-01

AMBIENT Super MULTIVAC 50 Wand with Integrated Finger Switches

Applicant ArthroCare Corporation

K-Number K180848

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LZA 2018-04-30

Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with Colloidal Oatmeal (Tested for use with Chemotherapy Drugs)

Applicant Medline Industries, Inc.

K-Number K180696

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KGO 2018-04-30

Finessis Intense Polyisoprene Surgical Glove

Applicant Lucenxia Prescience AG

K-Number K173304

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OLO 2018-04-30

Mazor X

Applicant Mazor Robotics , Ltd.

K-Number K180307

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EOQ 2018-04-30

EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433D

Applicant Olympus Medical Systems Corp.

K-Number K172726

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CCK 2018-04-30

Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 2.5m/8ft, 10/pkg, Disposable, Gas Sampling Line, Coextruded, 3m/10ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 6m/20ft, 5/pkg, Disposable

Applicant Vyaire Medical, Inc.

K-Number K171678

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IYO 2018-04-30

ExactVu High Resolution Micro-Ultrasound System

Applicant Exact Imaging, Inc.

K-Number K180636

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FTL 2018-04-30

VitaMESH Macroporous PP Surgical Mesh

Applicant Proxy Biomedical , Ltd.

K-Number K172636

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EBI 2018-04-27

Keymill

Applicant Mycone Dental Supply Company, Inc. (Aka Keystone Industries)

K-Number K172764

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OBJ 2018-04-27

Novasight Hybrid System

Applicant Conavi Medical, Inc.

K-Number K172258

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GXY 2018-04-27

NeuroCap

Applicant Memory MD, Inc.

K-Number K172866

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