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

QKB 2023-04-06

Contour ProtégéAI

Applicant Mim Software, Inc.

K-Number K223774

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OHT 2023-04-06

IPL Hair Removal Device, Model(s): BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108

Applicant Shenzhen Bsx Technology Electronics Co., Ltd.

K-Number K230097

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JAK 2023-04-06

AI-Rad Companion (Cardiovascular)

Applicant Siemens Medical Solutions U.S.A.

K-Number K222360

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EBI 2023-04-06

ACRIFIX

Applicant Deltamed GmbH

K-Number K230341

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LNH 2023-04-06

Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems

Applicant Philips Medical Systems Nederland B.V.

K-Number K223458

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DQY 2023-04-06

RayFlow

Applicant Hexacath

K-Number K222023

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MHX 2023-04-06

CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01)

Applicant GE Healthcare Finland Oy

K-Number K223531

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FMI 2023-04-06

Disposable Insulin Pen Needle

Applicant Hantech Medical Device Co., Ltd.

K-Number K222739

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MXD 2023-04-05

Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification System

Applicant Medtronic, Inc.

K-Number K223630

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PAY 2023-04-05

FAQ 101

Applicant Foreo, Inc.

K-Number K222012

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JSM 2023-04-05

BioSci Disposable Virus Sampling Tubes

Applicant Shenzhen Dakewe Bio-Engineering Co., Ltd.

K-Number K230035

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OHT 2023-04-05

Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588

Applicant Kam Yuen Plastic Products , Ltd.

K-Number K230107

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