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

NEU 2016-05-05

HydroMARK Breast Biopsy Site Marker

Applicant Devicor Medical Products, Inc.

K-Number K161021

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DXQ 2016-05-05

Cogent Hemodynamic Monitoring System

Applicant Icu Medical, Inc.

K-Number K152006

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GEX 2016-05-05

Alma Diode Tabletop Laser

Applicant Alma, Ltd.

K-Number K160952

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NKG 2016-05-05

Certex Spinal Fixation System

Applicant X-Spine Systems, Inc.

K-Number K160428

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MNH 2016-05-05

HC Spinal System

Applicant Hung Chun Bio-S Co., Ltd.

K-Number K151362

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MQL 2016-05-05

Sydney IVF Cryopreservation Kit, Sydney IVF Thawing Kit

Applicant Willian A. Cook Australia Pty, Ltd.

K-Number K152682

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MBI 2016-05-05

Flip Button Suture Anchor

Applicant First Ray, LLC

K-Number K153585

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IYN 2016-05-05

LOGIQ P9 and LOGIQ P7

Applicant GE Healthcare

K-Number K161047

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MHX 2016-05-05

Philips Efficia CMS200 Central Monitoring System

Applicant Philips Medical Systems

K-Number K160951

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LHI 2016-05-04

Vented Vial Adapter Transfer Device - 13mm

Applicant Medimop Medical Projects, Ltd.

K-Number K160503

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IYN 2016-05-04

6200 Ultrasound System and 6250 Ultrasound System

Applicant Esaote, S.p.A.

K-Number K153277

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NEY 2016-05-04

Certus 140 2.45GHz Ablation System

Applicant Neuwave Medical, Inc.

K-Number K160936

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