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

GEI 2019-06-13

Electrosurgical Generator

Applicant Fulwell, LLC

K-Number K183564

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LNH 2019-06-13

SyMRI

Applicant Syntheticmr AB

K-Number K191036

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FJL 2019-06-13

Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags

Applicant Corinth Medtech, Inc.

K-Number K191341

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LLZ 2019-06-13

ClariCT.AI

Applicant Claripi, Inc.

K-Number K183460

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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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