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

N/A 2026-06-24

CLEAR™ Aspiration System

Applicant Insera Therapeutics, Inc.

K-Number K253404

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JXG 2026-06-23

Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684)

Applicant Integra Lifesciences Production Corporation

K-Number K261004

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OMP 2026-06-23

CURASYS 2 (EMDN0003)

Applicant CG Bio Co., Ltd.

K-Number K253199

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BZH 2026-06-23

Microlife Digital Peak Flow Meter, Model PF200B (PF200B)

Applicant Microlife Corporation

K-Number K253180

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PZP 2026-06-23

AQUABEAM Robotic System

Applicant Procept Biorobotics

K-Number K253211

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OVE 2026-06-22

DeltaNEC Interbody System

Applicant Nexus Spine

K-Number K261279

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IOR 2026-06-22

Caregiver-assisted wheelchair (MS02);Caregiver-assisted wheelchair (MA02)

Applicant GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd.

K-Number K261076

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QIH 2026-06-22

CMN Capillary Function with Oncology Virtual Expert

Applicant Cercare Medical A/S

K-Number K260316

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LLZ 2026-06-22

Perfusion Measurement Platform v1

Applicant Quantified Imaging Limited

K-Number K253421

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DXQ 2026-06-22

Medline Reusable Blood Pressure Cuff

Applicant Medline Industries, LP

K-Number K254287

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IOR 2026-06-22

Manual Wheelchair (MS01);Manual Wheelchair (MA01)

Applicant GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd.

K-Number K261075

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MNR 2026-06-22

RX-1 Sleep

Applicant Vivaquant, Inc. Dba Rhythm Express

K-Number K253148

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