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

PNE 2025-12-19

Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer

Applicant Surgical Instrument Service and Savings, Inc.

K-Number K250314

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DXN 2025-12-19

Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L)

Applicant Ningbo Ranor Medical Science & Technology Co., Ltd.

K-Number K251143

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EMA 2025-12-19

iCEM Universal Plus

Applicant Kulzer, LLC

K-Number K254063

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JWH 2025-12-19

EMPOWR Knee

Applicant Encore Medical L.P.

K-Number K252974

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MAX 2025-12-19

IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)

Applicant Medicrea International S.A.S. (Medtronic)

K-Number K253577

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QJI 2025-12-19

DBLG2

Applicant Diabeloop

K-Number K251152

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KTI 2025-12-19

LIA-1 Catheter (542-1)

Applicant Leadoptik, Inc.

K-Number K251402

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KTT 2025-12-19

Monkey Rings External Ring Fixation System

Applicant Paragon 28, Inc.

K-Number K253613

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CAF 2025-12-19

eRapid with eTrack System

Applicant Pari Respiratory Equipment, Inc.

K-Number K251572

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MUJ 2025-12-19

ClearCalc Model RADCA V2.6

Applicant Radformation, Inc.

K-Number K252863

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QIH 2025-12-19

Alzevita

Applicant TOPIA MEDTECH LIMITED

K-Number K252670

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MBH 2025-12-19

Balanced Knee System TriMax Porous Femoral Components

Applicant Ortho Development Corp.

K-Number K253161

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