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

QAZ 2019-01-18

MUTYH-Associated Polyposis (MAP)

Applicant 23AndMe, Inc.

K-Number K182784

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OMP 2019-01-18

PICO 7Y Single Use Negative Pressure Wound Therapy System

Applicant Smith & Nephew Medical Limited

K-Number K182323

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GWG 2019-01-18

Aurora Surgiscope System

Applicant Rebound Therapeutics Corporation

K-Number K182211

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JKA 2019-01-18

Kurin PIV Blood Collection Set with High Pressure

Applicant Kurin, Inc.

K-Number K181895

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LPL 2019-01-18

DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 for ASTIGMATISM, DAILIES TOTAL1 Multifocal, DAILIES TOTAL1 Multifocal Toric

Applicant Alcon Laboratories, Inc.

K-Number K182782

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ODP 2019-01-18

Tyber Medical PT Interbody Spacer

Applicant Tyber Medical, LLC

K-Number K182284

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OBR 2019-01-18

Bright Guard

Applicant Koncept Innovators, LLC

K-Number K181099

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JTN 2019-01-18

HardyDisk AST Omadacycline 30µg (OMC30)

Applicant Hardy Diagnostics

K-Number K183298

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KOB 2019-01-18

Cook Cystostomy Catheter Set

Applicant Cook Incorporated

K-Number K181097

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OWQ 2019-01-18

Reprocessed Visions PV .035 Digital IVUS Catheter

Applicant Innovative Health, LLC

K-Number K181126

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LNH 2019-01-18

Magnetom Vida

Applicant Siemens Medical Solutions USA, Inc.

K-Number K183254

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BTL 2019-01-18

Puffin Lite Infant Resuscitation System

Applicant International Biomedical

K-Number K182956

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