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

PPW 2025-02-12

Etiometry Platform (DAV 5.4 RAE 9.2)

Applicant Etiometry, Inc.

K-Number K241479

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IYN 2025-02-12

V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System

Applicant Samsung Medison Co., Ltd.

K-Number K243702

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QIH 2025-02-12

SubtleHD (1.x)

Applicant Subtle Medical, Inc.

K-Number K243250

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ITI 2025-02-12

Electrically Powered Wheelchair

Applicant Kunshan Hi-Fortune Health Products Co., Ltd.

K-Number K243962

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DXO 2025-02-12

OptoMonitor 3

Applicant Opsens, Inc.

K-Number K241418

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LLZ 2025-02-12

AspenView

Applicant Aspen Imaging Healthcare, Inc.

K-Number K241425

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ITI 2025-02-12

Electrically Powered Wheelchair

Applicant Kunshan Hi-Fortune Health Products Co., Ltd.

K-Number K243961

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DXN 2025-02-11

Wrist Blood Pressure Monitor (XY-W01A, XY-W01B)

Applicant Guangdong Xinyu Electronic and Technology Co., Ltd.

K-Number K241634

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QRC 2025-02-11

MOR

Applicant Morari, Inc.

K-Number K241897

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OVE 2025-02-11

CYLOX® ST

Applicant Signus Medizintechnik GmbH

K-Number K243188

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QYT 2025-02-11

BinaxNOW COVID-19 Antigen Self Test

Applicant Abbott Diagnostics Scarborough, Inc.

K-Number K243518

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KWT 2025-02-11

InSet Total Shoulder System

Applicant Shoulder Innovations, Inc.

K-Number K241817

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