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

JTN 2018-09-26

HardyDisk AST Eravacycline 20µg (ERV20)

Applicant Hardy Diagnostics

K-Number K182357

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GEI 2018-09-26

InMode RF System

Applicant Inmode MD , Ltd.

K-Number K182325

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NUH 2018-09-26

Everyway Wireless TENS & EMS Unit

Applicant Everyway Medical Instruments Co.,Ltd

K-Number K181707

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MAX 2018-09-26

Fixated Asfora BULLET CAGE® (FABC)

Applicant Medical Designs, LLC

K-Number K181591

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DQY 2018-09-26

The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology

Applicant Access Scientific, LLC

K-Number K181563

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CGA 2018-09-26

Stat Profile Prime Plus Analyzer System

Applicant Nova Biomedical Corporation

K-Number K180340

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DQX 2018-09-26

Magic Torque DLVR Guidewire

Applicant Boston Scientific Corporation

K-Number K182315

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KLE 2018-09-26

BeautiBond Universal

Applicant Shofu Dental Corporation

K-Number K180803

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FKP 2018-09-26

NxStage Connected Health System

Applicant Nxstage Medical, Inc.

K-Number K181991

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LCP 2018-09-25

skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit)

Applicant Skyla Corporation H.S.P.B

K-Number K173127

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LCJ 2018-09-25

CPX 4 Breast Tissue Expander with Smooth Surface

Applicant Mentor Worldwide, LLC

K-Number K182335

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LLZ 2018-09-25

IBM iConnect Access

Applicant Merge Healthcare Incorporated

K-Number K182290

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