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

FRO 2024-05-31

Puracyn® Plus Antimicrobial Irrigation Solution

Applicant Innovacyn, Inc.

K-Number K232080

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EOQ 2024-05-31

BroncTru Transbronchial Access Tool

Applicant Broncus Medical, Inc.

K-Number K232601

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LCX 2024-05-31

Distinct® Digital Pregnancy Test

Applicant ACON Laboratories, Inc.

K-Number K232715

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IYE 2024-05-31

BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002)

Applicant Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla

K-Number K232738

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GEI 2024-05-31

Electro Lube NXT

Applicant Steris

K-Number K241055

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SBI 2024-05-31

LFR-260

Applicant Evolution Optiks Limited

K-Number K233295

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KNT 2024-05-31

Stylus

Applicant Degania Silicone , Ltd.

K-Number K233591

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QNQ 2024-05-31

Hypodermic Needle-Pro® EDGE Safety Device with Low Dead Space Syringe

Applicant Smiths Medical Asd, Inc.

K-Number K232943

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DZE 2024-05-31

S.I.N. Dental Implant System

Applicant S.I.N. - Sistema DE Implante Nacional S.A.

K-Number K232821

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ITI 2024-05-31

Electric Wheelchair (HBLD3-B); Electric Wheelchair (HBLD3-E)

Applicant Shanghai Hubang Intelligent Rehabilitation Equipment Co.,Ltd

K-Number K240913

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EBG 2024-05-31

Fixtemp® C&B 4:1

Applicant Dreve Denatmid GmbH

K-Number K241226

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DWF 2024-05-31

Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)

Applicant Spectrum Medical S.R.L.

K-Number K241248

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