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

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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HSB 2023-03-06

Pro-X1 Trochanteric Nailing System

Applicant X-Bolt Orthopedics

K-Number K221621

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DZE 2023-03-06

Provata Implant System

Applicant Southern Implants (Pty), Ltd.

K-Number K222457

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EBF 2023-03-06

LC ChromeFlow

Applicant S&C Polymer Silicon- Und Composite Spezialitaten GmbH

K-Number K222445

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CBN 2023-03-05

Nitronox Scavenger Plus

Applicant Parker Hannifin Corporation

K-Number K223452

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FDI 2023-03-03

Polypectomy Snare

Applicant Hangzhou AGS MedTech Co., Ltd.

K-Number K221713

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