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

LLZ 2026-06-08

2D Hip Planning Software

Applicant One Ortho

K-Number K261352

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QPB 2026-06-08

Lipocosm Harmonic System

Applicant Lipocosm, LLC

K-Number K251944

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INI 2026-06-08

Virgo Mobility Scooter (Virgo-D,Virgo-F)

Applicant Jiangsu Intco Medical Products Co., Ltd.

K-Number K253257

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QBJ 2026-06-08

Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring System

Applicant Dexcom, Inc.

K-Number K261402

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QZZ 2026-06-08

ELEOS™ with NanoCept® Technology Limb Salvage System

Applicant Onkos Surgical, Inc.

K-Number K253066

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HRS 2026-06-05

APTUS Clavicle System 2.8

Applicant Medartis AG

K-Number K260761

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KGN 2026-06-05

Catalyze

Applicant BioTissue Holdings, Inc.

K-Number K253204

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LPH 2026-06-05

iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating

Applicant Nextstep Arthopedix, LLC

K-Number K243192

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GEI 2026-06-05

OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K253656

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OXO 2026-06-05

Digital C-ARM with 3D

Applicant Allengers Medical Systems Limited

K-Number K253296

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FLL 2026-06-05

Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG)

Applicant Unimed Medical Supplies, Inc.

K-Number K253162

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DYB 2026-06-05

FieldFlex Steerable Sheath

Applicant CenterPoint Systems, LLC

K-Number K261492

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