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

GWL 2018-03-30

eego amplifiers

Applicant Eemagine Medical Imaging Solutions GmbH

K-Number K172312

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IWB 2018-03-30

Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon

Applicant Elekta Instrument AB

K-Number K173789

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LQY 2018-03-30

Dr’s Finder NEO

Applicant Good Doctors Co., Ltd.

K-Number K171867

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FJK 2018-03-30

Dimesol Tubing Sets for Hemodialysis

Applicant Dimesol, Inc.

K-Number K171952

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BZD 2018-03-30

Bleep DreamPort

Applicant Snapcpap

K-Number K172335

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FMF 2018-03-30

Nipro Syringe

Applicant Nipro Medical Corporation

K-Number K173029

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LLZ 2018-03-30

Vitrea Software Package; VSTP-001A

Applicant Canon Medical Systems Corporation

K-Number K180323

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KPR 2018-03-30

RADspeed fit

Applicant Shimadzu Corporation

K-Number K173517

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NYO 2018-03-30

ImmuLisa Enhanced RNA POL III Antibody ELISA

Applicant Immco Diagnostics, Inc.

K-Number K172078

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PNR 2018-03-30

AMSure® Enteral Feeding Syringe with ENFit Tip

Applicant Amsino International, Inc.

K-Number K171857

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LNH 2018-03-30

MAGNETOM Vida with Compressed Sensing GRASP-VIBE

Applicant Siemens Medical Solutions USA, Inc.

K-Number K173617

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JAK 2018-03-30

SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Deinition AS/AS+, SOMATOM Confidence

Applicant Siemens Medical Solutions USA, Inc.

K-Number K173630

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