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

HGX 2019-06-12

Lansinoh Signature Pro Double Electric Breast Pump, Lansinoh Smartpump Double Electric Breast Pump

Applicant Lansinoh Laboratories Saglik Gerecleri Tasarim San. Tic., Ltd.

K-Number K182749

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GBM 2019-06-12

Medline Poly-Cath Red Polymer Urethral Catheter

Applicant Medline Industries, Inc.

K-Number K183335

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KNW 2019-06-12

J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle,

Applicant Ranfac Corporation

K-Number K190177

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JAK 2019-06-12

Aquilion ONE (TSX-305A/6) V8.9 with AiCE

Applicant Canon Medical Systems Corporation

K-Number K183046

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KWQ 2019-06-12

Lateral Plate System

Applicant Corelink, LLC

K-Number K190016

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JGS 2019-06-12

LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600

Applicant Ams Diagnostics

K-Number K172232

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GEI 2019-06-12

Argon Handset

Applicant New Deantronics Taiwan , Ltd.

K-Number K191064

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GEI 2019-06-12

Viveve System 2.0

Applicant Viveve Medical

K-Number K190422

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NBW 2019-06-12

On Call Express Voice Blood Glucose Monitoring System

Applicant ACON Laboratories, Inc.

K-Number K191038

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IYN 2019-06-12

HS40 Diagnostic Ultrasound System

Applicant Samsung Medison Co., Ltd.

K-Number K191055

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LIH 2019-06-12

Avid IF2

Applicant Vision Quest Industries Inc./Dba VQ Orthocare

K-Number K183692

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KWS 2019-06-12

Aequalis Ascend Flex Shoulder System

Applicant Tornier S.A.S.

K-Number K190521

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