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

OLO 2026-07-01

OTS Hip

Applicant Ortoma AB

K-Number K261852

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NHA 2026-07-01

Neodent Implant System - NeoConvert Fit

Applicant JJGC Indústria e Comércio de Materiais Dentários S.A.

K-Number K261147

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LLZ 2026-06-30

MeVis AVM Contour

Applicant MeVis Medical Solutions AG

K-Number K260576

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DQK 2026-06-30

NorthStar Mapping System (MAP01 or MAP01-01)

Applicant Imricor Medical Systems, Inc.

K-Number K261119

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EIH 2026-06-30

Dandy Ceramic Stain and Glaze

Applicant Zima International Inc., dba Dandy

K-Number K262195

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GEH 2026-06-30

Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)

Applicant Serpex Medical

K-Number K261068

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OLT 2026-06-30

UB ERP System

Applicant Universal Brain

K-Number K253767

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OMC 2026-06-30

Ceribell Monitor

Applicant Ceribell, Inc.

K-Number K261101

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QJP 2026-06-30

ISAAC Neurovascular Navigation Catheter

Applicant Microvention Inc. d/b/a Terumo Neuro

K-Number K261808

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QIH 2026-06-29

Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012)

Applicant Agada Medical, Ltd.

K-Number K253628

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GEI 2026-06-29

LUTRONIC GENIUS

Applicant Cynosure Lutronic Technology Corporation

K-Number K253484

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OWQ 2026-06-29

Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825); Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657484); Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510826); Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657485)

Applicant Sterilmed, Inc.

K-Number K254149

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