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

LSR 2018-05-02

Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit

Applicant Gold Standard Diagnostics

K-Number K180264

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LZC 2018-05-02

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

Applicant Maxter Glove Manufacturing Sdn Bhd

K-Number K172864

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CAF 2018-05-02

MC 300R* Nebulizer

Applicant Trudell Medical International

K-Number K173825

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QBQ 2018-05-01

BacterioScan 216Dx System

Applicant Bacterioscan, Inc.

K-Number K172412

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FRO 2018-05-01

LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate Dressing

Applicant Huizhou Foryou Medical Devices Co., Ltd.

K-Number K172554

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FGE 2018-05-01

Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter, Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, Multipurpose Drainage Catheters and Sets

Applicant Cook Incorporated

K-Number K173035

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LBI 2018-05-01

BiliLux

Applicant Draeger Medical Systems, Inc.

K-Number K172656

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MWI 2018-05-01

PeraServer and PeraTrend

Applicant Perahealth, Inc.

K-Number K172959

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FKX 2018-05-01

Liberty Cycler Set

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K-Number K173718

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OLP 2018-05-01

SAPPHIRE, ELEVARE SAPPHIRE

Applicant Omm Imports, Inc. D/B/A Zero Gravity

K-Number K172555

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IMJ 2018-05-01

ViaTherm BOOST

Applicant Viatherm Therapeutics, LLC

K-Number K173300

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GEI 2018-05-01

AMBIENT Super MULTIVAC 50 Wand with Integrated Finger Switches

Applicant ArthroCare Corporation

K-Number K180848

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