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

KGO 2017-06-09

Sterile Nitrile Surgical Gloves, Powder-free

Applicant Primus Gloves Pvt Limited

K-Number K170515

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MQB 2017-06-09

1717SCC_127um and 1717SCC_140um

Applicant Rayence Co., Ltd.

K-Number K171420

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DQY 2017-06-09

Wingman 14C Crossing Catheter

Applicant Reflow Medical, Inc.

K-Number K170996

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HSB 2017-06-09

PRECICE Intramedullary Limb Lengthening System

Applicant Nuvasive Specialized Orthopedics, Inc.

K-Number K170169

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HWC 2017-06-09

2-Piece Hammertoe Correction System

Applicant Life Spine, Inc.

K-Number K162685

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OWI 2017-06-09

JAZZ System, including JAZZ Band

Applicant Implanet, S.A.

K-Number K170730

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FMF 2017-06-09

CompuFlo Epidural Computer Controlled Anesthesia System

Applicant Milestone Scientific, Inc.

K-Number K161883

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MQB 2017-06-09

1717SGC_127um and 1717SGC_140um

Applicant Rayence Co., Ltd.

K-Number K171419

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NUC 2017-06-09

YES oil-based Personal Lubricant, YES Water-based Personal Lubricant, YES Vaginal Moisturizer

Applicant Biotech Lubricants, Ltd.

K-Number K162569

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ITX 2017-06-09

ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor

Applicant CIVCO Medical Instruments Co., Inc.

K-Number K163313

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FYA 2017-06-09

Cardinal Health Non-Reinforced Surgical Gown

Applicant Cardinal Health200, LLC

K-Number K170762

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INI 2017-06-08

Quingo Flyte Mobility Scooter

Applicant Agile Distributors, LLC

K-Number K171256

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