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

NDN 2018-05-29

SpineKure Kyphoplasty System

Applicant Hanchang Co., Ltd.

K-Number K172871

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DWF 2018-05-25

ProtekDuo Mini Veno-Venous Cannula Set

Applicant Cardiacassist, Inc.

K-Number K181150

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FLN 2018-05-25

DripAssist Plus

Applicant Shift Labs, Inc.

K-Number K172242

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NDY 2018-05-25

ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K181082

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NAY 2018-05-25

TransEnterix Senhance Surgical System

Applicant Transenterix, Inc.

K-Number K180163

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MUU 2018-05-25

Automatic Tissue Processing Unit

Applicant Bsl Co.

K-Number K172717

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BSK 2018-05-25

VORTRAN Cuff Inflator (VCI)

Applicant Vortran Medical Technology 1, Inc.

K-Number K173914

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MWI 2018-05-25

STAR 65

Applicant Skanray Technologies Pvt, Ltd.

K-Number K172147

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FLL 2018-05-25

Infrared Thermometer

Applicant Shenzhen Pacom Medical Instruments Co., Ltd.

K-Number K172889

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KGN 2018-05-25

SURECELL Gelling Fiber Wound Dressing

Applicant Jiangsu Newvalue Medical Producst Co.,Ltd

K-Number K173005

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DTQ 2018-05-25

Quantum Pump Console

Applicant Spectrum Medical , Ltd.

K-Number K173834

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HQF 2018-05-25

PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar

Applicant Topcon Medical Laser Systems, Inc.

K-Number K180402

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