Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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

NRY 2017-12-21

Riptide Aspiration System

Applicant Micro Therapeutics, Inc. d/b/a ev3 Neurovascular

K-Number K172448

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PZZ 2017-12-21

MMPC-4127F1

Applicant Barco N.V.

K-Number K172922

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HRS 2017-12-21

Life Spine Foot and Ankle Plating System

Applicant Life Spine, Inc.

K-Number K172973

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MYA 2017-12-21

FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis)

Applicant Dako Denmark A/S

K-Number K170028

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GDW 2017-12-21

easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use

Applicant Ezisurg Medical Co., Ltd.

K-Number K172960

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KWQ 2017-12-21

Anterior Cervical Plate System

Applicant Evolution Spine, LLC

K-Number K173375

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MXZ 2017-12-21

FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis)

Applicant Dako Denmark A/S

K-Number K170005

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DRC 2017-12-21

SafeSept Needle Free Transseptal Guidewire

Applicant Pressure Products Medical Device Manufacturing, LLC

K-Number K172893

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MQP 2017-12-20

T2 STRATOSPHERE Expandable Corpectomy System

Applicant Medtronic Sofamor Danek

K-Number K173125

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HGX 2017-12-20

Electric Breast Pump

Applicant Joytech Healthcare Co. , Ltd.

K-Number K172989

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IYN 2017-12-20

LOGIQ E10

Applicant GE Healthcare

K-Number K173555

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KIF 2017-12-20

Well-Root ST

Applicant Vericom Co., Ltd.

K-Number K170950

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