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

MHX 2019-07-10

Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)

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

K-Number K190011

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DQY 2019-07-10

Scepter Mini Occlusion Balloon Catheter

Applicant MicroVention, Inc.

K-Number K182829

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IYN 2019-07-10

Full Digital Colour Doppler Ultrasonic Diagnostic System

Applicant Wuhan Zoncare Bio-medical Electronics Co., Ltd.

K-Number K183041

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IYO 2019-07-10

Vave Personal Ultrasound System

Applicant Vave Health, Inc.

K-Number K191541

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DXN 2019-07-10

Microlife Upper Arm Automatic Digital Blood Pressure Monitor

Applicant Microlife Intellectual Property GmbH

K-Number K190818

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GBM 2019-07-10

SpeediCath Flex Coude Pro

Applicant Coloplast

K-Number K190620

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NKB 2019-07-10

Salvo™ Spine System

Applicant Spine Wave, Inc.

K-Number K191045

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DWA 2019-07-10

CentriMag Acute Circulatory Support System

Applicant Thoratec Corporation (Now Part of Abbott)

K-Number K191557

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NXO 2019-07-10

CalprestNG, EasyCal

Applicant Eurospital S.P.A.

K-Number K191592

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NHA 2019-07-10

Conometric Abutments

Applicant Dentsply Sirona, Inc.

K-Number K183079

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NXO 2019-07-10

Calprest, EasyCal

Applicant Eurospital S.P.A.

K-Number K191589

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FRG 2019-07-09

Heat Sealing Sterilization Pouch Flat, Heat Sealing Sterilization Pouch Gusseted, Heat Sealing Sterilization Pouch Roll Flat, Heat Sealing Sterilization Pouch Roll Gusseted

Applicant Tianchang Jiarui Packaging Material Co., Ltd.

K-Number K181957

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