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

CEW 2023-09-05

VITROS Immunodiagnostic Products Intact PTH II Reagent Pack

Applicant Ortho Clinical Diagnostics

K-Number K221197

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OYX 2023-09-05

BCR-ABL1 (p210) % IS Kit (Digital PCR Method)

Applicant Suzhou Sniper Medical Technologies Co., Ltd.

K-Number K221869

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EBI 2023-09-05

Polibond

Applicant Zirkonzahn Srl

K-Number K232691

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IOR 2023-09-05

Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL

Applicant Ki Mobility, LLC

K-Number K200583

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LNH 2023-09-05

Promaxo MRI System II

Applicant Promaxo, Inc.

K-Number K232361

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ITI 2023-09-05

Ki Power Tilt System

Applicant Ki Mobility, LLC

K-Number K201869

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QME 2023-09-01

FaceHeart Vitals Software Development Kit (FH vitals SDK)

Applicant Faceheart Corp.

K-Number K223622

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KPE 2023-09-01

eZSURE Empty Fluid Container (models 426030, 426040, 426110)

Applicant Epic Medical Pte. , Ltd.

K-Number K223674

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HRS 2023-09-01

TriMed Clavicle Fixation System

Applicant TriMed, Inc.

K-Number K230805

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MAX 2023-09-01

CONDUIT ATP Inserters

Applicant Enztec Limited

K-Number K232014

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HRS 2023-09-01

KITE Distal Fibula Kit

Applicant Intrauma S.P.A

K-Number K230623

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LRK 2023-09-01

ApneaRX Pro

Applicant Apnea Sciences Coporation

K-Number K223901

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