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

OLO 2016-05-26

Stealth-Midas System

Applicant Medtronic Powered Surgical Solutions

K-Number K160713

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HJO 2016-05-26

Z5 Slit lamp microscope, Z2 Slit lamp microscope

Applicant Takagi Seiko Co., Ltd.

K-Number K152535

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NKB 2016-05-26

Mariner Pedicle Screw System

Applicant SeaSpine Orthopedics Corporation

K-Number K160902

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FTY 2016-05-26

Noxilizer Surgical Ruler

Applicant Noxilizer, Inc.

K-Number K160501

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OCX 2016-05-26

Seal Single-Use Biopsy Valve

Applicant Endochoice, Inc.

K-Number K161167

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GCJ 2016-05-26

Radiance Ultra Series ZeroWire Embedded

Applicant Nds Surgical Imaging, LLC

K-Number K161228

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LPH 2016-05-26

G7 Dual Mobility System, Active Articulation System

Applicant Biomet, Inc.

K-Number K161190

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EOQ 2016-05-26

Auris Robotic Endoscopy System (ARES)

Applicant Auris Surgical Robotics, Inc.

K-Number K152319

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FTM 2016-05-26

Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug

Applicant Cook Biotech Incorporated

K-Number K161221

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LYZ 2016-05-26

Yongchang Powder-Free Yellow Vinyl Patient Examination Gloves

Applicant Ideal Plastic Co., Ltd.

K-Number K152818

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DZL 2016-05-26

MC BIO Supertack Tack 3mm, 4mm and 5mm

Applicant Eli-Ka Technologies

K-Number K151540

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LEL 2016-05-25

ActTrust

Applicant Condor Instruments Ltda. - Epp

K-Number K151784

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