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

PHX 2026-06-10

MSS - Humeral reverse liners extension

Applicant Medacta International, SA

K-Number K261016

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SIH 2026-06-10

Colli-Pee•Dx Urine Collection Kit

Applicant DNA Genotek, Inc.

K-Number K254121

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KLW 2026-06-10

Tinnitus Therapy

Applicant Sivantos GmbH

K-Number K260614

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OVD 2026-06-10

Anteralign LS coverplate

Applicant Tyber Medical, LLC

K-Number K260810

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SAO 2026-06-10

DeepXray Spina

Applicant Alpha Intelligence Manifolds, Inc.

K-Number K253192

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NRY 2026-06-10

Penumbra System (Thunderbolt Aspiration Tubing)

Applicant Penumbra, Inc.

K-Number K250690

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NHA 2026-06-09

DESS Dental Smart Solutions

Applicant Terrats Medical SL

K-Number K260564

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QUW 2026-06-09

TekBrace Solo Soft Tissue Reinforcement Device

Applicant Theramicro

K-Number K261621

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GEH 2026-06-09

ERBECRYO 2 Cryosurgical Unit and Accessories

Applicant Erbe Elektromedizin GmbH

K-Number K261806

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QHE 2026-06-09

Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner

Applicant Materialise NV

K-Number K260802

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NKB 2026-06-09

ChanPin Pedicle Screw Spinal System

Applicant Chanpin Medtak Co., Ltd.

K-Number K251251

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GEI 2026-06-09

LAP-iX2N

Applicant Sejong Medical Co., Ltd.

K-Number K253165

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