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

LRK 2025-09-11

Nylon flexTAP(R)

Applicant Airway Technologies D/B/A Airway Management

K-Number K252374

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LYX 2025-09-11

XTRA4

Applicant Al.Chi.Mi.A. S.R.L

K-Number K251320

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SFR 2025-09-11

Hypertension Notification Feature (HTNF)

Applicant Apple, Inc.

K-Number K250507

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NXC 2025-09-11

Serafin®

Applicant Tns Co., Ltd.

K-Number K251758

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LNH 2025-09-11

SIGNA Sprint

Applicant Ge Medical Systems, LLC

K-Number K251399

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DJG 2025-09-11

SEFRIA Hydrocodone Oral Fluid

Applicant Immunalysis Corporation

K-Number K252520

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QGQ 2025-09-11

OsteoProbe (OP-100)

Applicant Active Life Scientific, Inc.

K-Number K250216

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LLZ 2025-09-11

Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2)

Applicant Augment Intelligent Medical System (China) Co., Ltd.

K-Number K242314

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QEB 2025-09-10

Enlight 2100 (TPL-E2103-0)

Applicant Timpel S.A.

K-Number K250464

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LPL 2025-09-10

VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens

Applicant Vizionfocus, Inc.

K-Number K251573

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SBF 2025-09-10

OptiVu Shoulder

Applicant Mr Surgical Solutions, LLC

K-Number K252530

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QJH 2025-09-10

Surfacer Inside-Out Access Catheter System

Applicant Merit Medical System, Inc.

K-Number K252527

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