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

LZO 2025-08-07

Longboard Revision Hip Stem

Applicant Signature Orthopaedics Pty, Ltd.

K-Number K243021

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KWL 2025-08-06

InterSpace GV Hip Spacer

Applicant Tecres S.P.A.

K-Number K252326

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GEX 2025-08-06

Olo

Applicant El.En S.P.A.

K-Number K251432

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MBI 2025-08-06

Aevumed PHANTOM Suture Anchors

Applicant Aevumed, Inc.

K-Number K242895

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FPA 2025-08-06

SteadiSet infusion set

Applicant Tandem Diabetes Care

K-Number K251854

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JXG 2025-08-06

Codman Libertís 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761); Codman Libertís 1.9 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821762)

Applicant Integra Lifesciences Production Corporation

K-Number K243552

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LNH 2025-08-06

InVision 3T Recharge Operating Suite

Applicant Imris Imaging, Inc.

K-Number K252239

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LLZ 2025-08-06

Digital Radiographic Imaging Acquisition Software - DR (RiasDR)

Applicant Shen Zhen Cambridge-Hit Co., Ltd.

K-Number K251038

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DPS 2025-08-06

Cardiologs Holter Platform

Applicant Philips France Commercial

K-Number K250569

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DXN 2025-08-06

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress (BP3T01-1B)

Applicant Microlife Corporation

K-Number K251120

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GCJ 2025-08-06

Viction Disposable Irrigation and suction catheter (VC-IRA0532, VC-IRA0523, VC-IRB0532, VC-IRB0523, VC-IRC0532, VC-IRC0523, VC-IRD0532, VC-IRD0532)

Applicant Hangzhou Viction Medical Technology Co.,Ltd

K-Number K250124

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GCJ 2025-08-06

Viction Disposable Irrigation and suction System (VC-FLA0514; VC-FLA0523; VC-FLA0532; VC-FLB0514; VC-FLB0523; VC-FLB0532; VC-FLC0514; VC-FLC0523; VC-FLC0532; VC-FLD0514; VC-FLD0523; VC-FLD0532)

Applicant Hangzhou Viction Medical Technology Co.,Ltd

K-Number K250130

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