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

QJI 2019-12-13

Control-IQ Technology

Applicant Tandem Diabetes Care, Inc.

K-Number DEN190034

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NBW 2019-12-13

ReliOn Premier Classic Blood Glucose Monitoring System

Applicant I-Sens, Inc.

K-Number K192220

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FYA 2019-12-13

Aero Blue Performance Surgical Gowns

Applicant O&M Halyard, Inc.

K-Number K192362

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FLL 2019-12-13

Infrared Thermometer, model: PC808

Applicant Shenzhen Pacom Medical Instruments Co., Ltd.

K-Number K190717

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OAP 2019-12-13

Laser Hair Growth Cap

Applicant Shang FA Biotechnology Co.

K-Number K192627

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GBM 2019-12-13

VaPro Plus Pocket, VaPro Plus

Applicant Hollister Incorporated

K-Number K193148

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IYN 2019-12-13

DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic Ultrasound System

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K192152

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PSN 2019-12-13

Demetra BDEM-01 Dermatoscope

Applicant Barco N.V.

K-Number K192829

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MAX 2019-12-12

Genesys Spine 3DP Lumbar Interbody System

Applicant Genesys Spine

K-Number K182987

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KDI 2019-12-12

Tablo Hemodialysis System, Tablo Cartridge

Applicant Outset Medical, Inc.

K-Number K190793

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MAI 2019-12-12

Arthrex 3.9mm Corkscrew Suture Anchor

Applicant Arthrex, Inc.

K-Number K193157

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JOH 2019-12-12

Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange Set

Applicant Cook Incorporated

K-Number K193133

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