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

FLL 2023-07-21

Infrared Thermometer, Model: IR8807

Applicant Shen Zhen Rong Feng Technology Co., Ltd.

K-Number K223037

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PGW 2023-07-21

TruDi® Navigation System V3 (FG-2000-00)

Applicant Acclarent, Inc.

K-Number K231862

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FMG 2023-07-21

Three Way Stop Cock

Applicant M/S Romsons International

K-Number K223499

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QEW 2023-07-21

Triever20 Curve (21-201)

Applicant Inari Medical, Inc.

K-Number K231848

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CJE 2023-07-21

Alkaline Phosphatase2

Applicant Abbott Ireland Diagnostics Division

K-Number K223317

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FPA 2023-07-21

BD Alaris Pump Infusion Sets

Applicant Care Fusion

K-Number K221327

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FRN 2023-07-21

BD Alaris System with Guardrails Suite MX v12.1.2

Applicant Carefusion 303, Inc.

K-Number K211218

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NGT 2023-07-21

0.9% Sodium Chloride Injection, USP BD PosiFlush SF Saline Flush Syringe

Applicant Becton, Dickinson and Company

K-Number K231161

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QDB 2023-07-21

Irregular Rhythm Notification Feature (IRNF)

Applicant Apple, Inc.

K-Number K231173

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SBF 2023-07-21

NextAR Spine Platform

Applicant Medacta International S.A.

K-Number K223769

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QIH 2023-07-21

OptimMRI

Applicant Rebrain, Sas

K-Number K230150

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LOX 2023-07-21

Firefighter NC Pro PTCA Balloon Catheter

Applicant Shanghai MicroPort Medical (Group) Co., Ltd.

K-Number K223189

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