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

ITI 2024-11-20

Powered Wheelchair (NXN20-208, NXN20-211)

Applicant Zhejiang Nysin Medical Co., Ltd.

K-Number K241603

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QIH 2024-11-20

Strain AI (SAI001)

Applicant Exo, Inc.

K-Number K242359

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DYB 2024-11-20

Element Vascular Access System

Applicant Penumbra, Inc.

K-Number K242520

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QNQ 2024-11-20

SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle, SOL-M Luer Lock Syringe (Low Dead Space) w/Exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/Exchangeable Needle

Applicant Sol-Millennium Medical, Inc.

K-Number K242291

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OVE 2024-11-20

ProAM ACDF System

Applicant Pro Surgical, Inc.

K-Number K242517

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EIH 2024-11-20

Estar-ZE

Applicant Osstem Implant Co., Ltd.

K-Number K242521

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MBB 2024-11-20

Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds

Applicant Osartis GmbH

K-Number K240856

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BZG 2024-11-20

TD-7301 Spirometer (TD-7301)

Applicant Gostar Co., Ltd.

K-Number K241843

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PBX 2024-11-20

INDIBA COMPACT devices

Applicant Indiba S. A. U.

K-Number K243164

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QJP 2024-11-20

Neurovascular Access System Family

Applicant Q'Apel Medical, Inc.

K-Number K240746

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NGL 2024-11-20

ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test

Applicant Eterbio, Inc.

K-Number K243064

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PZI 2024-11-19

XPER Technology PREMIUM Pro Blood Glucose Monitoring System

Applicant Taidoc Technology Corporation

K-Number K221349

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