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

NEY 2023-03-07

Solero Microwave Tissue Ablation (MTA) System and Accessories

Applicant AngioDynamics, Inc.

K-Number K221883

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FYA 2023-03-07

Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL)

Applicant Xiamen Probtain Medical Techology Co., Ltd.

K-Number K223401

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DZJ 2023-03-07

MedCAD AccuPlan System

Applicant Medcad

K-Number K223024

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QEW 2023-03-07

Protrieve Sheath

Applicant Inari Medical, Inc.

K-Number K230331

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FXX 2023-03-06

Procedure mask/Surgical mask/Face mask

Applicant Winner Medical Co., Ltd.

K-Number K223232

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FXX 2023-03-06

Savvy Surgical Mask - Level 3

Applicant Alg Health, LLC

K-Number K230383

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PQA 2023-03-06

BD Vaginal Panel

Applicant Becton, Dickinson and Company

K-Number K223653

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QHE 2023-03-06

Materialise Shoulder System™ Materialise Shoulder Guide and Models SurgiCase Shoulder Planner

Applicant Materialise NV

K-Number K230315

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MWI 2023-03-06

Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories

Applicant Masimo Corporation

K-Number K212161

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FGB 2023-03-06

Single-Use Video Flexible Ureterorenoscope System

Applicant Guangzhou Red Pine Medical Instrument Co., Ltd.

K-Number K221158

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FMF 2023-03-06

Disposable Insulin Syringe

Applicant Hantech Medical Device Co., Ltd.

K-Number K222672

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MQB 2023-03-06

A1417MCW/A1717MCW/F1417MCW

Applicant H&abyz Co., Ltd.

K-Number K223930

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