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

LYA 2025-07-11

TurbAlign

Applicant Spirair, Inc.

K-Number K243655

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ITX 2025-07-11

ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R)

Applicant Olympus Medical Systems Corporation

K-Number K250762

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JFB 2025-07-11

Ceragem Automatic Thermal Massager (CGM MB-2401)

Applicant Ceragem Co., Ltd.

K-Number K250266

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NLH 2025-07-11

Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter

Applicant Surgical Instrument Service and Savings, Inc.

K-Number K250772

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KNW 2025-07-11

Disposable Biopsy Needle

Applicant Carbon (Shenzhen) Medical Device Co., Ltd.

K-Number K243296

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IYO 2025-07-11

B-Scan

Applicant Accutome, Inc. Doing Business AS Keeler USA

K-Number K243227

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HIS 2025-07-11

Natural rubber latex male condom

Applicant Shaoguan Regenex Pharmaceuticals Co., Ltd.

K-Number K250034

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GEX 2025-07-11

AviClear Laser System

Applicant Cutera, Inc.

K-Number K251149

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EMA 2025-07-11

Choice 2 DC

Applicant Bisco, Inc.

K-Number K250156

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CAW 2025-07-11

FreeStyle Comfort (AS200 / FreeStyle Comfort)

Applicant Caire, Inc.

K-Number K250671

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GAG 2025-07-11

AEON Endoscopic Powered Stapler

Applicant Lexington Medical, Inc.

K-Number K251482

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QYX 2025-07-11

Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)

Applicant VivaQuant, Inc.

K-Number K241179

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