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

EIA 2025-06-27

Integral Dental Unit

Applicant Guangdong Yadeng Medical Apparatus Co., Ltd.,

K-Number K243130

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HRS 2025-06-27

Genostis Osteosynthesis System

Applicant Genostis AF

K-Number K242988

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OBP 2025-06-27

Ampa One System (AMPA-001)

Applicant Neuromodulatory Devices & Applications

K-Number K251210

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DWF 2025-06-27

Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)

Applicant Sorin Group Italia S.R.L.

K-Number K250610

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FAS 2025-06-27

Multi4 System

Applicant Multi4 Medical AB

K-Number K250522

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GEX 2025-06-27

Diode laser device (RF3120-BI)

Applicant Risu Medical Technology Co., Ltd.

K-Number K251329

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DZE 2025-06-27

T3 Pro Implants ZimVie Packaging System

Applicant Biomet 3i, LLC

K-Number K251660

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FED 2025-06-27

LumenaTM Ureteral Access Sheath

Applicant Cathegenix (Xiamen) Co., Ltd.

K-Number K250585

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ELW 2025-06-27

JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST

Applicant Dent4you AG

K-Number K250969

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BSP 2025-06-27

SonoPlex STIM; SonoPlex II

Applicant PAJUNK GmbH Medizintechnologie

K-Number K243682

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IZI 2025-06-27

Affirm 800

Applicant Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)

K-Number K243077

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BZQ 2025-06-27

RTMsense Respiratory Monitoring System

Applicant Rtm Vital Signs, LLC

K-Number K243183

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