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

EIH 2023-06-30

Easy On Universal Glaze & Stain

Applicant Doctus Global

K-Number K231264

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OYK 2023-06-30

Vantage PSI System

Applicant 3D Systems, Inc.

K-Number K231585

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QXA 2023-06-30

FebriDx Bacterial / Non-bacterial Point of Care Assay

Applicant Lumos Diagnostics, Inc.

K-Number K230917

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KLW 2023-06-30

Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042)

Applicant Duearity AB

K-Number K223694

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DWJ 2023-06-30

IOB Temperature Management System

Applicant Iob Medical, Inc.

K-Number K231596

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FEB 2023-06-30

enspire 3000 Cleaning and Liquid Chemical Sterile Processing System

Applicant STERIS Corporation

K-Number K230930

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NEZ 2023-06-30

PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E

Applicant Given Imaging Ltd. (Medtronic)

K-Number K230991

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MJN 2023-06-30

preCARDIA Occlusion System

Applicant Abiomed, Inc.

K-Number K221294

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DXN 2023-06-30

Blood Pressure Monitor

Applicant Guangdong Transtek Medical Electronics Co., Ltd.

K-Number K223374

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MAX 2023-06-30

Ventana™ L Spinal System

Applicant Spinal Elements, Inc.

K-Number K231252

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OUR 2023-06-30

iFuse TORQ® Implant System

Applicant SI-BONE, Inc.

K-Number K231689

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JWY 2023-06-30

Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC, or Breakpoint Susceptibility System with Imipenem-relebactam in the dilution, range of 0.03/4-128-4ug/ml (Haemophilus influenzae)

Applicant Thermo Fisher Scientific

K-Number K230935

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