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

DXN 2022-10-06

A&D Medical UM-212BLE Blood Pressure Monitor

Applicant A&D Company, Ltd.

K-Number K212168

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MBF 2022-10-06

PRIMA TT Glenoid

Applicant Lima Corporate S.P.A.

K-Number K222427

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IMD 2022-10-06

InfaTherm Disposable Infant Warming Mattress

Applicant International Biomedical

K-Number K221653

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MQP 2022-10-06

ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)

Applicant Arftx Medical, LLC

K-Number K211892

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LRK 2022-10-06

ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring

Applicant Prosomnus Sleep Technologies

K-Number K221889

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FRG 2022-10-06

Gemini Sterilization Wrap

Applicant Medline Industries, LP

K-Number K220365

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OWB 2022-10-06

Garion Image-Intensified Fluoroscopic X-Ray System, Mobile

Applicant Sg Healthcare Co, Ltd.

K-Number K222080

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JWH 2022-10-06

b-ONER MOBIO Total Knee System

Applicant B-One Ortho, Corp.

K-Number K222431

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DQO 2022-10-06

NuCath Wedge Pressure Catheter

Applicant Pfm Medical, Inc.

K-Number K213666

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QDQ 2022-10-06

Genius AI Detection 2.0

Applicant Hologic, Inc.

K-Number K221449

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HKY 2022-10-06

iCare IC200

Applicant Icare Finland OY

K-Number K220852

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GEI 2022-10-05

Surtron 80 D, Surtron 160, Surtron 200, Surtron Flash 160 HF, Surtron 400 HP

Applicant Led Spa

K-Number K220138

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