Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

EBF 2025-09-29

G-BLOCK

Applicant Graphenano Dental S.L.

K-Number K253236

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DYB 2025-09-29

Primero Safe Access System

Applicant South53, LLC

K-Number K252441

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QIH 2025-09-29

SMART PCFD

Applicant Disior, Ltd.

K-Number K250023

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SBF 2025-09-29

SpineAR SNAP (SyncAR Spine)

Applicant Surgical Theater, Inc.

K-Number K252054

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DZL 2025-09-29

Master-Pin X (MP Pin with thread) (36BMP000030 / MP30)

Applicant Hager& Meisinger GmbH

K-Number K250123

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CAW 2025-09-29

Portable oxygen concentrator (JAY-1000P)

Applicant Longfian Scitech Co., Ltd.

K-Number K243833

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QFG 2025-09-29

iLet ACE Pump

Applicant Beta Bionics, Inc.

K-Number K252770

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GEI 2025-09-29

NEW DOUBLO 2.0

Applicant Hironic Co., Ltd.

K-Number K251334

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KNS 2025-09-29

SureTome™ SW Sphincterotome with DomeTip

Applicant Wilson-Cook Medical

K-Number K251104

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SBG 2025-09-29

allay Nerve Cap (TL5515-1); allay Nerve Cap (TL5515-2); Delivery Tips (TL-7627)

Applicant Tulavi Therapeutics, Inc.

K-Number K252051

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DZE 2025-09-29

Paltop Dental Implant System

Applicant Paltop Advanced Dental Solutions, Ltd.

K-Number K243983

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HRX 2025-09-29

UltraGuideCTR® image guided soft tissue release system

Applicant Sonex Health

K-Number K252594

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