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

DQY 2016-10-14

R2P SlenGuide

Applicant Ashitaka Factory of Terumo Corporation

K-Number K161546

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DIS 2016-10-14

Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators

Applicant Immunalysis Corporation

K-Number K161714

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LPH 2016-10-14

iNSitu Total Hip System

Applicant Theken Companies, LLC

K-Number K161184

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MCW 2016-10-14

HawkOne Directional Atherectomy System

Applicant Medtronic Vascular, Inc.

K-Number K161361

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DZE 2016-10-14

IH Implant System

Applicant Sewonmedix, Inc.

K-Number K153521

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MQB 2016-10-14

BSD3543 Digital Flat Panel X-ray Detector

Applicant Bontech, Inc.

K-Number K162487

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PDJ 2016-10-14

D-10 Hemoglobin A1c Program

Applicant Bio-Rad Laboratories, Inc.

K-Number K161687

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MOF 2016-10-14

ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip

Applicant Asahi Intecc Co., Ltd.

K-Number K161912

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MAX 2016-10-13

XCage Interbody Fusion System

Applicant Ouroboros Medical, Inc.

K-Number K160076

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LZA 2016-10-13

Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs

Applicant Hartalega Snd. Bhd.

K-Number K160562

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NKB 2016-10-13

Overwatch Spine System

Applicant Amendia, Inc.

K-Number K161842

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LOL 2016-10-13

ADVIA Centaur HAV IgM Assay

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K161964

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