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

PQI 2017-10-25

CleanCision Wound Retraction and Protection System

Applicant Prescient Surgical, Inc.

K-Number K172132

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MUI 2017-10-25

Advance Medical Designs, Inc. Sterile Ultrasound Gel

Applicant Advance Medical Designs, Inc.

K-Number K163050

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LPL 2017-10-25

AIR OPTIX COLORS, AIR OPTIX COLORS Toric, AIR OPTIX COLORS Multifocal

Applicant Alcon Laboratories, Inc.

K-Number K172600

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DXN 2017-10-25

Automatic Blood Pressure Monitor Model LD-562U, LD-588U & LD-533U

Applicant Honsun (Nantong) Co., Ltd.

K-Number K170454

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KCT 2017-10-25

iTotal Family Reusable Instrument Tray

Applicant Conformis, Inc.

K-Number K170226

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IYE 2017-10-25

SunCHECK

Applicant Sun Nuclear Corporation

K-Number K170307

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PYQ 2017-10-25

DentureID Microchip

Applicant Cmp Industries, LLC

K-Number K170423

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IYO 2017-10-25

CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation Kit

Applicant Volcano Corporation

K-Number K172455

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HWC 2017-10-25

Treace Medical Concepts (TMC) Compression Screw System

Applicant Treace Medical Concepts, Inc.

K-Number K172617

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MAX 2017-10-25

Cortina Lumbar Cage System

Applicant Neurostructures, Inc.

K-Number K171914

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FTM 2017-10-25

CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large)

Applicant Aziyo Biologics, Inc.

K-Number K173242

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FZP 2017-10-25

AtriClip LAA Exclusion System with Preloaded PRO·V Clip

Applicant AtriCure, Inc.

K-Number K173031

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