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

JAK 2025-06-18

CardIQ Suite

Applicant GE Medical Systems SCS

K-Number K243672

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DJG 2025-06-18

LZI Fentanyl III Enzyme Immunoassay

Applicant Lin-Zhi International, Inc.

K-Number K251634

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OVD 2025-06-18

Curiteva Porous PEEK Standalone ALIF System

Applicant Curiteva, Inc.

K-Number K250845

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NKB 2025-06-18

Virata Spinal Fixation System

Applicant SeaSpine Orthopedics Corporation

K-Number K250908

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FAD 2025-06-18

Ureteral Stents (AF-D series)

Applicant Alton (Shanghai) Medical Instruments Co., Ltd.

K-Number K243039

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IYN 2025-06-18

EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems

Applicant Philips Ultrasound, LLC

K-Number K250886

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DQY 2025-06-18

FlexiGo 3D Delivery Catheter

Applicant CenterPoint Systems, LLC

K-Number K250492

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LZA 2025-06-18

Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Singles

Applicant O&M Halyard, Inc.

K-Number K243172

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ITH 2025-06-18

DRX9000C-SL Cervical Spinal Decompression System

Applicant Excite Medical of Tampa Bay, LLC

K-Number K243366

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LNS 2025-06-18

Extracorporeal Shock Wave Lithotripter (U200)

Applicant Shenzhen Wikkon Precision Technologies Co., Ltd.

K-Number K242922

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OAP 2025-06-17

CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A)

Applicant Shenzhen Kaiyan Medical Equipment Co., Ltd.

K-Number K251017

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QVL 2025-06-17

Oxiplex®

Applicant Fziomed, Inc.

K-Number DEN240038

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