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

FOZ 2024-12-20

Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00622); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00820); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00822)

Applicant Arrow International, LLC (A subsidiary of Teleflex, Inc.)

K-Number K242281

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EKX 2024-12-20

HPR Cordless Hygiene Handpiece

Applicant Handpiece Headquarters

K-Number K243911

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OLO 2024-12-20

ExcelsiusGPS® Instruments

Applicant Globus Medical, Inc.

K-Number K243671

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NEU 2024-12-20

SmartClip Secure Soft Tissue Marker

Applicant Elucent Medical, Inc.

K-Number K233639

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HGX 2024-12-20

Momcozy Wearable Breast Pump (BP311); Momcozy Wearable Breast Pump (BP223); Momcozy Wearable Breast Pump (BP324); Momcozy Wearable Breast Pump (BP334); Momcozy Wearable Breast Pump (BP430)

Applicant Shenzhen Root Innovation Technology Co., , Ltd.

K-Number K243629

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OCZ 2024-12-20

SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230)

Applicant Envision Endoscopy

K-Number K242923

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HGX 2024-12-20

Momcozy Wearable Breast Pump (BP311)

Applicant Shenzhen Root Innovation Technology Co., Ltd.

K-Number K241680

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MBH 2024-12-20

Zimmer® Persona® Personalized Knee System

Applicant Zimmer Biomet

K-Number K243293

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OHS 2024-12-20

LED Light Therapy Mask (SKB-1818P,SKB-1918,SKB-1918P,SKB-1918PLUS,SKB-2318L,SKB-2318P,SKB-2318PRO,IN-FM002, SKB-2418)

Applicant Shenzhen Siken 3D Technology Development Co., Ltd.

K-Number K243040

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FJK 2024-12-20

Moda-flx Hemodialysis System Cartridge (102121-001 )

Applicant Diality, Inc.

K-Number K243607

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DZE 2024-12-20

Alpha Dent Implants Dental Implants System

Applicant Alpha Dent Implants GmbH

K-Number K240435

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HRS 2024-12-20

Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, LEPORELLO 3.5mm Olecranon Syste)

Applicant Bonebridge AG

K-Number K243308

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