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

OWT 2019-07-31

GORE BIO-A Tissue Reinforcement

Applicant W. L. Gore & Associates, Inc.

K-Number K191773

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OBO 2019-07-31

P200TxE

Applicant Optos Plc.

K-Number K190732

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JTN 2019-07-31

HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25)

Applicant Hardy Diagnostics

K-Number K191931

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LPN 2019-07-31

AOCup Lens Case with AODisc

Applicant Alcon Laboratories, Inc.

K-Number K191795

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HAW 2019-07-31

StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1

Applicant Medtronic Navigation, Inc.

K-Number K190672

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IYE 2019-07-31

Mobius3D

Applicant Varian Medical Systems, Inc.

K-Number K191761

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QDG 2019-07-31

Fluobeam LX

Applicant Fluoptics

K-Number K190891

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GEX 2019-07-31

Diode Laser Therapy Systems

Applicant Wingderm Electro-Optics , Ltd.

K-Number K191611

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DRF 2019-07-30

Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter

Applicant Medtronic

K-Number K190132

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LZA 2019-07-30

Powder Free Blue Nitrile Examination Gloves - Tested for Use with Chemotherapy Drugs

Applicant Platinum Glove Industries Sdn. Bhd.

K-Number K182089

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CBK 2019-07-30

Hamilton-G5

Applicant Hamiton Medical AG

K-Number K180295

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JKA 2019-07-30

Blood Collection Accessory (BUCA)

Applicant Nsp Tech Pte, Ltd.

K-Number K181754

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