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

QRX 2026-09-08

MODI System

Applicant DreaMed Diabetes, Ltd.

K-Number K260062

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KWT 2026-09-08

N22 Offset Humeral Head

Applicant Shoulder Innovations, Inc.

K-Number K262173

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PUM 2026-09-08

Emboliner Embolic Protection System (EPC-03)

Applicant Emboline, Inc.

K-Number K261715

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MBH 2026-09-08

LANDMARK Total Knee System

Applicant Smith & Nephew, Inc.

K-Number K261462

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EKX 2026-09-08

Reusable SmartPeg

Applicant Osstell AB

K-Number K261987

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ITI 2026-09-08

Power Wheelchair (OS-R-M01I)

Applicant Beijing OrionStar Technology Co., Ltd.

K-Number K260053

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JWH 2026-09-08

b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions

Applicant B-One Ortho, Corp.

K-Number K262341

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PEM 2026-09-08

Dental Barriers and Sleeves (AB0006)

Applicant ANI Co., Ltd.

K-Number K261956

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ITI 2026-09-08

Electric wheelchair (HC819N, HC830N, HC831N)

Applicant Yongkang Hengyi Vehicle Co., Ltd.

K-Number K260229

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KCT 2026-09-08

LiteSet Trays

Applicant Nobel Biocare AB

K-Number K253988

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LZA 2026-09-08

Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric Acid

Applicant Gmp Medicare Sdn. Bhd.

K-Number K260312

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NUH 2026-09-06

Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J, AST-309J, AST-310J;AST-300Q, AST-300Q-A, AST-500B; AST-500G, AST-500F; AST-500N; AST- 500C, AST- 500K, AST-500A; AST-300E, AST-500M, AST- 500U, AST- 500D; AST- 500E.)

Applicant Shenzhen Osto Medical Technology Co.,Ltd

K-Number K261131

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