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

QIH 2024-09-06

uAI Portal

Applicant Shanghai United Imaging Intelligence Co., Ltd.

K-Number K240411

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KLC 2024-09-06

Luvis Chair (LC700C)

Applicant Dentis Co., Ltd.

K-Number K233921

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NDS 2024-09-06

MSC SFM

Applicant Yocon Biology Technology Company

K-Number K232543

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MAX 2024-09-06

Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)

Applicant Shanghai Iatrical-Ti Technologies CO , Ltd.

K-Number K232996

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GEX 2024-09-06

COPRO 3

Applicant Amt Engineering Co., Ltd.

K-Number K241672

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EIH 2024-09-06

DD Hybridlayer (multicolored zirconia)

Applicant Dental Direkt GmbH

K-Number K241579

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JWH 2024-09-06

ACS® LD FB Knee System

Applicant Implantcast GmbH

K-Number K234044

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MAX 2024-09-06

IB3D PL Spinal System

Applicant Medicrea International S.A.S. (Medtronic)

K-Number K241164

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MRD 2024-09-06

MENTOR MemoryGel Enhance Single Use Gel Sizer

Applicant Mentor Worldwide, LLC

K-Number K241552

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QIS 2024-09-06

Mucosal Impedance Measurement System

Applicant Alandra Medical Sapi DE CV

K-Number K233974

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DRF 2024-09-06

Nordica PV Cryo Mapping Catheter

Applicant Synaptic Medical Corporation

K-Number K233900

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DYB 2024-09-06

SafeCross Vascular Introducer System (4001)

Applicant East End Medical I, LLC

K-Number K240600

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