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

LPL 2018-04-10

Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP Toric / DACP Multifocal, FreshLook One-Day, DAILIES Total1, DAILIES Total1 Multifocal

Applicant Alcon Laboratories, Inc.

K-Number K180398

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NKB 2018-04-10

Mercury® Spinal System

Applicant Spinal Elements, Inc.

K-Number K172967

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NKB 2018-04-10

AXIS 5.5 Lumbar Pedicle Screw System

Applicant Axis Orthopaedics

K-Number K180301

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KOD 2018-04-10

Imager II Urology Torque Catheter

Applicant Boston Scientific Corporation

K-Number K180530

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BTO 2018-04-10

BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube

Applicant Smiths Medical Ads, Inc.

K-Number K173384

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KNW 2018-04-10

Eviva Stereotactic Guided Breast Biopsy System

Applicant Hologic, Inc.

K-Number K180233

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OWI 2018-04-10

NAJA Ligament Correction System

Applicant Cousin Biotech Sas

K-Number K172206

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DZE 2018-04-10

DTI-1 SLA IMPLANT SYSTEM

Applicant Dti Implant Sistemleri Sanayi Ticaret Anonim Sirketi

K-Number K170776

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DXN 2018-04-10

Digital Automatic Wrist Blood Pressure Monitor MD4300

Applicant Grandway Technology (Shenzhen) Limited

K-Number K171379

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QAV 2018-04-10

Precision Flow® HVNI

Applicant Vapotherm, Inc.

K-Number DEN170001

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LPL 2018-04-10

ACUVUE OASYS (senofilcon A) with Photochromic Additive

Applicant Johnson & Johnson Vision Care, Inc.

K-Number K180299

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HGH 2018-04-09

Hysteroscopy System

Applicant Chongquin Jinshan Science & Technology (Group) Co., Ltd.

K-Number K172151

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