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

PGI 2024-05-03

Alinity m HSV 1 & 2 / VZV

Applicant Abbott Molecular, Inc.

K-Number K233349

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EZD 2024-05-03

Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not Finalized); Sleeved IC 2 Pocket (Name not Finalized); Sleeved IC 2 Plus Pocket (Name not Finalized)

Applicant Hollister Incorporated

K-Number K233524

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GEX 2024-05-03

VaporMAX LDD; MOJo LDD; MegaJOULE LDD

Applicant Innovaquartz, LLC

K-Number K233157

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LHI 2024-05-03

Vial2Bag Advanced® 20mm Admixture Device

Applicant West Pharmaceutical Services, Inc.

K-Number K240940

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MIX 2024-05-03

Silk Voice (SMI-04)

Applicant Sofregen Medical

K-Number K240919

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GEJ 2024-05-03

Cypris eXact Suture Placement Device

Applicant Cypris Medical

K-Number K240185

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IYO 2024-05-03

B-Ultrasound Diagnostic System

Applicant Contec Medical Systems Co.,Ltd

K-Number K232895

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QYU 2024-05-03

Masimo Stork

Applicant Masimo Corporation

K-Number K234021

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OLO 2024-05-03

CORUS Navigation Access System

Applicant Providence Medical Technology, Inc.

K-Number K240625

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OAB 2024-05-03

Canady Helios Cold Plasma XL-1000CP Ablation System (XL-1000CPSYS)

Applicant Us Medical Innovations, LLC

K-Number K240297

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JSM 2024-05-03

Viral Transport Media (VTM)

Applicant Alb Luz

K-Number K232454

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QEI 2024-05-03

Emily's Care Nourish Test System (Model 1)

Applicant Lactation Lab, Inc.

K-Number K234088

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