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

PDU 2019-01-21

XableCath Crossing Catheter

Applicant Xablecath, Inc.

K-Number K183357

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MBI 2019-01-21

Tigon Medical Tissue Anchors

Applicant Tigon Medical

K-Number K182507

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HBF 2019-01-20

Codman Disposable Perforators

Applicant Integra Lifesciences Corp.

K-Number K183581

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HBE 2019-01-19

ELAN 4 Tools

Applicant Aesculap, Inc.

K-Number K182527

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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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