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

NGT 2023-07-13

Praxiject 0.9% NaCl

Applicant Medxl, Inc.

K-Number K231754

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KPS 2023-07-13

Biograph Vision.X and Biograph Vision.X Edge

Applicant Siemens Medical Solutions USA, Inc.

K-Number K231833

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LSR 2023-07-13

ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit

Applicant Zeus Scientific

K-Number K230863

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EBF 2023-07-13

Admira Fusion 5

Applicant Voco GmbH

K-Number K230877

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LLZ 2023-07-13

XR90 (XR90-SYS)

Applicant Mediview Xr, Inc.

K-Number K223125

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EHD 2023-07-13

Portable X-ray System Model Ray98(P)

Applicant Ningbo Runyes Medical Instrument Co., Ltd.

K-Number K231449

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JLW 2023-07-13

Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K222116

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KWT 2023-07-12

Comprehensive Segmental Revision System(SRS)

Applicant Biomet Orthopedics

K-Number K223631

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OLO 2023-07-12

Zavation Navigation Instrument System

Applicant Zavation Medical Products, LLC

K-Number K223808

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MQB 2023-07-12

AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4

Applicant Radmedix, LLC

K-Number K231709

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MQV 2023-07-12

Graftys Quickset

Applicant Graftys

K-Number K231714

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MAX 2023-07-12

NanoHive Medical Lumbar Interbody System

Applicant NanoHive Medical, LLC

K-Number K231241

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