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

OVD 2017-08-28

IRIX-A Lumbar Integrated Fusion System

Applicant X-Spine Systems, Inc.

K-Number K171567

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MMX 2017-08-28

Captus Vascular Retrieval System

Applicant Avantec Vascular Corporation

K-Number K170987

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LZO 2017-08-28

PROCOTYL® PRIME E-CLASS XLPE Liner

Applicant Microport Orthopedics, Inc.

K-Number K171181

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DZB 2017-08-28

Reverse Pull Adjustable Facemask

Applicant Sawbros Industries Pvt., Ltd.

K-Number K162543

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FAD 2017-08-28

Salle Intraoperative Pyeloplasty Stent Set

Applicant Cook Incorporated

K-Number K170010

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KWQ 2017-08-28

2 Hole Lateral Plating System

Applicant Life Spine, Inc.

K-Number K172131

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GDW 2017-08-28

Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue Reload, Dextera MicroCutter 30 White Reload, Dextera MicroCutter 30 Curved Tip White Reload

Applicant Dextera Surgical, Inc.

K-Number K171561

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HGX 2017-08-28

Moxxly Flow Collection System

Applicant Moxxly, Inc.

K-Number K170722

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MRZ 2017-08-25

Sapphire Sets

Applicant Icu Medical

K-Number K171346

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GWQ 2017-08-25

Nihon Kohden Wireless Input Unit WEE-1200

Applicant Nihon Kohden Corporation

K-Number K171124

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FRG 2017-08-25

Standard Supreme Sterilization Wrapper

Applicant Standard Textile Co., Inc.

K-Number K172207

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LZO 2017-08-25

Locking Cage, Full XPE Cup

Applicant United Orthopedic Corporation

K-Number K163441

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