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

FDT 2017-09-20

PENTAX Medical ED34-i10T, Video Duodenoscope

Applicant Pentax Medical

K-Number K163614

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OMP 2017-09-20

PICO Single Use Negative Pressure Wound Therapy System

Applicant Smith & Nephew Medical Limited

K-Number K172521

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NBW 2017-09-20

NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352)

Applicant Biotest Medical Corporation

K-Number K171822

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EIH 2017-09-20

Ceramill Zolid HT+ white

Applicant Amann Girrbach AG

K-Number K171876

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NKG 2017-09-20

PMT Posterior Fixation System

Applicant Providence Medical Technology, Inc.

K-Number K172279

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DQA 2017-09-19

Finger Pulse Oximeter

Applicant Shenzhen Fitfaith Technology Co.,Ltd

K-Number K163135

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MAX 2017-09-19

ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium

Applicant Medtronic Sofamor Danek

K-Number K172199

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DSB 2017-09-19

ECOM™ Cardiac Output Monitoring System

Applicant Ecom Medical, Inc.

K-Number K172196

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MBI 2017-09-19

LigaMetrics Suture Anchors

Applicant Mortise Medical, LLC

K-Number K171964

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NAY 2017-09-19

da Vinci Xi Surgical System

Applicant Intuitive Surgical, Inc.

K-Number K171632

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NUH 2017-09-19

Pain Therapy Device

Applicant Guangzhou Xinbo Electronic Co., Ltd.

K-Number K163611

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FFL 2017-09-19

Accordion Piccolo Stone Management Device

Applicant Ths International, Inc. D/B/A Accordion Medical

K-Number K172299

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