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

QOF 2025-05-01

Xpert Xpress CoV-2/Flu/RSV plus

Applicant Cepheid®

K-Number K250996

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JWY 2025-04-30

ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL)

Applicant Biomerieux S.A.

K-Number K250274

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HKI 2025-04-30

Resolve Fundus Camera

Applicant Optain Health, Inc.

K-Number K250683

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EOQ 2025-04-30

LumiRex Bronchoscope

Applicant Contra Healthcare Solutions, LLC

K-Number K243541

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JKA 2025-04-30

Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set

Applicant Sol-Millennium Medical, Inc.

K-Number K250907

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EBF 2025-04-30

Additive Manufacturing (Light Curing) Crown Bridge Resin

Applicant Aidite (Qinhuangdao) Technology Co., Ltd.

K-Number K250497

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NHA 2025-04-30

Dentsply Sirona Titanium Bases system

Applicant Dentsply Sirona

K-Number K250295

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QIH 2025-04-30

UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program

Applicant Canon Medical Systems Corporation

K-Number K250328

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DXN 2025-04-30

Arm Blood Pressure Monitor (ARM-30A+);Arm Blood Pressure Monitor (ARM-30G2);Arm Blood Pressure Monitor (ARM-30Q);Arm Blood Pressure Monitor (ARM-30E+);

Applicant Shenzhen AOJ Medical Technology Co., Ltd.

K-Number K244000

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JPA 2025-04-30

TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge

Applicant Haemonetics

K-Number K251024

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OVD 2025-04-30

Stable-L Lumbar Interbody System

Applicant Nexus Spine, LLC

K-Number K243934

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DWJ 2025-04-30

Arctic Sun Stat Temperature Management System

Applicant Medivance, Inc.

K-Number K243942

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