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

QGY 2019-05-21

Smith & Nephew Tablet Application

Applicant Smith & Nephew

K-Number K190367

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HIH 2019-05-21

MAKO 7

Applicant Boston Scientific Corporation

K-Number K182975

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ITI 2019-05-21

Solax Powered Wheelchair

Applicant Dongguan Prestige Sporting Goods Co., Ltd.

K-Number K182576

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QAQ 2019-05-21

Acumen Hypotension Prediction Index EV1000 Clinical Platform, Acumen Hypotension Prediction Index HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index HemoSphere Advanced Monitoring Platform - Pressure

Applicant Edwards Lifeciences, LLC

K-Number K183646

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DZE 2019-05-21

ET IV SA Dental Implants

Applicant Hiossen, Inc.

K-Number K183242

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HWC 2019-05-21

IntraLock Lapidus System

Applicant Fusion Orthopedics, LLC

K-Number K182342

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GWO 2019-05-21

Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)

Applicant Kelyniam Global, Inc.

K-Number K182711

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DYB 2019-05-20

VersaCross Transseptal Sheath

Applicant Baylis Medical Company, Inc.

K-Number K183655

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DXN 2019-05-20

Full Automatic (NIBP) Blood Pressure Monitor-HL158TB

Applicant Health & Life Co., Ltd.

K-Number K190134

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MMK 2019-05-20

OnSite Waste Sharps Container

Applicant Bluestone Medical, Inc.

K-Number K182235

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PSY 2019-05-20

Aperio AT2 DX System

Applicant Leica Biosystems Imaging, Inc.

K-Number K190332

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QGT 2019-05-20

Nerivio Migra

Applicant Theranica Bioelectronics , Ltd.

K-Number DEN180059

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