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

QRX 2023-08-11

BlueStar CGM insulin dose calculator

Applicant Welldoc, Inc.

K-Number K222888

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MRN 2023-08-11

NOxBOXi Nitric Oxide Delivery System

Applicant Linde Gas & Equipment, Inc.

K-Number K231823

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LZA 2023-08-11

Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile

Applicant Shandong Intco Medical Products Co, Ltd.

K-Number K231408

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QAI 2023-08-11

Dr. pen Microneedling System

Applicant Guangzhou Ekai Electronic Technology Co., Ltd.

K-Number K230420

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CAF 2023-08-11

eRapid Nebulizer System

Applicant Pari Respiratory Equipment, Inc.

K-Number K223840

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EOQ 2023-08-10

Ambu® aScope 5 Broncho 2.7/1.2, Ambu® aScope 5 Broncho 4.2/2.2, Ambu® aBox 2

Applicant Ambu A/S

K-Number K230428

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LOL 2023-08-10

HAVAb IgG II

Applicant Abbott Laboratories

K-Number K222850

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CHL 2023-08-10

GEM Premier 7000 with IQM3

Applicant Instrumentation Laboratory Company

K-Number K223608

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NBW 2023-08-10

ReliOn Premier BLU Blood Glucose Monitoring System

Applicant I-Sens, Inc.

K-Number K230625

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BTT 2023-08-10

AirLife DuoTherm Humidification System

Applicant Vyaire Medical, Inc.

K-Number K231380

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GEX 2023-08-10

ZenPro 40

Applicant BLUECORE COMPANY Co., Ltd.

K-Number K230268

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GAT 2023-08-10

SuperBall Meniscal Repair System

Applicant Arcuro Medical , Ltd.

K-Number K223500

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