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

IYN 2024-02-21

HD60 Series Ultrasound Diagnostic System

Applicant Qingdao Hisense Medical Equipment Co., Ltd.

K-Number K233439

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BTY 2024-02-21

Pulmonary Function Tester, Model: A9

Applicant Guangzhou Homesun Medical Technology Co., Ltd.

K-Number K231561

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PHX 2024-02-21

BLUEPRINT Patient Specific Instrumentation

Applicant Tornier S.A.S.

K-Number K232265

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MBI 2024-02-21

ProCinch, QuadCinch

Applicant Riverpoint Medical

K-Number K240194

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QZU 2024-02-21

BraidE Embolization Assist Device

Applicant Rapid Medical , Ltd.

K-Number DEN230064

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DWJ 2024-02-21

Cocoon Convective Warming System, Model CWS7000

Applicant Care Essentials Pty, Ltd.

K-Number K232502

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NHA 2024-02-21

Oneday Implant Abutment

Applicant Oneday Biotech Co., Ltd.

K-Number K231753

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OLO 2024-02-21

ROSA® Shoulder System

Applicant Orthosoft Inc (D/B/A Zimmer Cas)

K-Number K233199

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QVJ 2024-02-20

Mjolnir Pro. (Multielectrode plasma)

Applicant Shenzhen Leaflife Technology Co., Ltd.

K-Number K233760

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NLQ 2024-02-20

Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136)

Applicant Stryker Sustainability Solutions

K-Number K233471

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JDS 2024-02-20

NET BRAND Osteosynthesis Nailing System

Applicant Narang Medical , Ltd.

K-Number K233150

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LAO 2024-02-20

ONLINE TDM Methotrexate

Applicant Roche Diagnostics Operations

K-Number K233454

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