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

ODP 2026-01-15

Curiteva Porous PEEK Cervical Interbody Fusion System

Applicant Curiteva, Inc.

K-Number K254061

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QHW 2026-01-15

Bio-Medicus Life Support Catheter and Introducer

Applicant Medtronic, Inc.

K-Number K251831

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ITI 2026-01-15

Electric Wheelchair (Robooter E80) (BBR-E80-01); Electric Wheelchair (Robooter E80) (BBR-E80-02)

Applicant Shanghai Bangbang Robotics Co., Ltd.

K-Number K253276

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LBI 2026-01-15

SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)

Applicant Thera B Medical Products

K-Number K251308

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QFG 2026-01-15

MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894)

Applicant Medtronic Minimed, Inc.

K-Number K253470

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PHX 2026-01-15

AltiVate Reverse® ADLC Glenosphere

Applicant Encore Medical L.P.

K-Number K252567

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NRY 2026-01-15

Esperance pHLO Aspiration System

Applicant Phenox, Ltd.

K-Number K251357

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GXN 2026-01-14

METICULY Patient-specific titanium mesh implant

Applicant Meticuly Co., Ltd.

K-Number K252958

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IYE 2026-01-14

ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface

Applicant Brainlab SE

K-Number K254010

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GEI 2026-01-14

ENTire IRE System

Applicant Entire Medical , Ltd.

K-Number K251996

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QJI 2026-01-14

SmartGuard technology; Predictive Low Glucose technology

Applicant Medtronic Minimed, Inc.

K-Number K253585

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BTT 2026-01-14

Laboratorios Biogalenic Sterile Water for Inhalation, USP

Applicant Laboratorios Biogalenic S.A. DE C.V.

K-Number K251419

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