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

JKA 2023-04-28

Kurin Blood Culture Collection Set with Kurin Lock Technology

Applicant Kurin, Inc.

K-Number K220677

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ODP 2023-04-28

INTEGRATE -C Interbody Fusion System

Applicant Happe Spine

K-Number K222004

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FZP 2023-04-28

Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML)

Applicant Teleflex Medical

K-Number K230480

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OHS 2023-04-28

Q-Rejuvalight Pro Facewear (Model: P19-0023)

Applicant Light Tree Ventures Europe B.V.

K-Number K230042

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LNH 2023-04-28

Ingenia Elition and MR 7700 MR Systems

Applicant Philips Medical Systems Nederland B.V.

K-Number K230972

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DQX 2023-04-28

BNLE Access Guidewire

Applicant Biomerics Nle

K-Number K221390

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NHA 2023-04-28

Customized Abutment

Applicant Arum Dentistry Co., Ltd.

K-Number K223634

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OAP 2023-04-28

Hair Boom 69, Hair BoomAir, Hair Boom, Ulike Hair UpUp

Applicant Wontech Co., Ltd.

K-Number K223862

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KPS 2023-04-28

VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)

Applicant Spectrum Dynamics Medical, Ltd.

K-Number K230600

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NHA 2023-04-28

ET Abutment System

Applicant Hiossen, Inc.

K-Number K222636

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GEX 2023-04-27

Epildream HP 4000 MED

Applicant D.E.A Project S.R.1.

K-Number K222352

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PGY 2023-04-27

32HL512D, 31HN713D, 32HQ713D

Applicant Lg Electronics.Inc

K-Number K230845

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