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

GCJ 2024-08-28

da Vinci Handheld Camera

Applicant Intuitive Surgical Operations, Inc.

K-Number K241913

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OCL 2024-08-27

Isolator Synergy EnCapture Ablation System (EMH)

Applicant AtriCure, Inc.

K-Number K234151

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GZJ 2024-08-27

TENSWave

Applicant Zynex Medical Officer

K-Number K241228

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ITI 2024-08-27

Electric wheelchair (S7018)

Applicant Guangdong Prestige Technology Company Limited

K-Number K240270

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DXT 2024-08-27

Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)

Applicant Nemoto Kyorindo Co., Ltd.

K-Number K242212

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LZO 2024-08-27

Z1 Cemented Hip System

Applicant Orchard Medical Development, LLC

K-Number K241241

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QIH 2024-08-27

Overjet Charting Assist

Applicant Overjet, Inc.

K-Number K241684

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FBK 2024-08-27

injeTAK Adjustable Tip Needle (DIS199; DIS201)

Applicant Laborie Medical Technologies, Corp.

K-Number K241523

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MQL 2024-08-27

Vitrification Solution Set and Warming Solution Set

Applicant Ecmpc, LLC

K-Number K233846

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NBW 2024-08-27

CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System

Applicant Ascensia Diabetes Care U.S., Inc.

K-Number K241787

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DYH 2024-08-27

BracePaste Fluoride Sealant

Applicant American Orthodontics Corp.

K-Number K242537

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OLO 2024-08-27

Q Guidance System; Mako Spine System;

Applicant Stryker Leibinger GmbH & Co KG

K-Number K241517

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