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

GAT 2017-01-06

SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader

Applicant ArthroCare Corporation

K-Number K163142

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FDF 2017-01-06

Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex balloon - Olympus Linear; Oracle EUS latex balloon - Fujinon Radial; Oracle EUS latex balloon - Fujinon Linear

Applicant United States Endoscopy Group, Inc.

K-Number K163492

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DQX 2017-01-06

Spectre guidewire

Applicant Vascular Solutions, Inc.

K-Number K163444

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FPA 2017-01-06

Hospira Extension Set, Hospira Primary Set

Applicant Hospira, Inc.

K-Number K161036

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LNH 2017-01-06

Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3

Applicant Philips Medical Systems Nederland B.V.

K-Number K163116

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PZI 2017-01-06

StatStrip Xpress 2 Glucose Hospital Meter System

Applicant Nova Biomedical Corporation

K-Number K163490

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DZE 2017-01-05

Chaorum Implant System

Applicant Medimecca Co., Ltd.

K-Number K160536

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GGN 2017-01-05

VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit

Applicant Maine Standards Company, LLC

K-Number K162705

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LSE 2017-01-05

LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set

Applicant DiaSorin, Inc.

K-Number K162961

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MCW 2017-01-05

Turbo-Power (2.0mm) Laser Atherectomy Catheters

Applicant Spectranetics, Inc.

K-Number K162561

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LLZ 2017-01-05

Arterys Cardio DL

Applicant Arterys, Inc.

K-Number K163253

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GEH 2017-01-05

C2 Cryoballoon Ablation System

Applicant C2 Therapeutics, Inc.

K-Number K161202

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