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

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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HGX 2026-06-09

Mother's Nature W1 Warming Wearable Breast Pump

Applicant Shenzhen TPH Technology Co., Ltd.

K-Number K260864

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NUC 2026-06-09

Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)

Applicant Hathor Professional Skincare , Ltd.

K-Number K252914

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QJP 2026-06-09

BOBBY Balloon Guide Catheter

Applicant MicroVention, Inc., d/b/a Terumo Neuro

K-Number K261549

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IYN 2026-06-09

ES-Series

Applicant E-Scopics

K-Number K260748

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