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

HGX 2024-03-13

Hygeia Express Powered Breast Pump

Applicant Hygeia II Medical Group, Inc.

K-Number K233136

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QGM 2024-03-13

Edison System

Applicant HistoSonics, Inc.

K-Number K233466

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QAS 2024-03-13

CINA-iPE

Applicant Avicenna.Ai

K-Number K233968

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LLZ 2024-03-13

MRCP+ version 2 (MRCP+ v2)

Applicant Perspectum

K-Number K233930

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QRR 2024-03-13

CERAMENT G

Applicant Bonesupport AB

K-Number K234008

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QJI 2024-03-13

DEKA Loop

Applicant Deka Research and Development

K-Number K234055

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GEH 2024-03-13

ICEfx Cryoablation System (FPRCH8000-02)

Applicant Boston Scientific

K-Number K234002

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QFG 2024-03-13

DEKA ACE Pump System

Applicant Deka Research and Development

K-Number K233952

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KWI 2024-03-13

BioPoly Radial Head Implant

Applicant BioPoly, LLC

K-Number K233592

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NGX 2024-03-13

Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N)

Applicant Chongqing Rob Linka Science and Technology Co., Ltd.

K-Number K233070

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KPR 2024-03-12

DRX-Evolution Plus System

Applicant Carestream Health, Inc.

K-Number K233381

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GEX 2024-03-12

Smartxide Tetra Pro

Applicant El.En S.P.A.

K-Number K240497

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