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

FLE 2026-06-24

AMSCO 700 Steam Sterilizer

Applicant STERIS Corporation

K-Number K261055

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KRD 2026-06-24

Concerto Versa™ Detachable Coil

Applicant Medtronic, Inc.

K-Number K261866

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FGE 2026-06-24

Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019 AG-5251-085519 AG-5251-088019 AG-5251-083021 AG-5251-085521 AG-5251-088021 AG-5251-083024 AG-5251-085524 AG-5251-088024 AG-5251-103018 AG-5251-105518 AG-5251-108018 AG-5251-103019 AG-5251-105519 AG-5251-108019 AG-5251-103021 AG-5251-105521 AG-5251-108021 AG-5251-103024 AG-5251-105524 AG-5251-108024 AG-5251-123018 AG-5251-125518 AG-5251-128018 AG-5251-123019 AG-5251-125519 AG-5251-128019

Applicant Hangzhou AGS MedTech Co., Ltd.

K-Number K253393

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OMP 2026-06-24

ConvaVAC™ Negative Pressure Wound Therapy System

Applicant Convatec Limited, Gdc Building

K-Number K253263

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OMB 2026-06-24

Ceribell Neurology Review Software

Applicant Ceribell, Inc.

K-Number K260998

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LZA 2026-06-24

Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution

Applicant Sw Technologies, Inc.

K-Number K252117

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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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