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

PAY 2023-08-30

Silk'n Titan Allways

Applicant Silk'N Beauty , Ltd.

K-Number K230013

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MBI 2023-08-30

AlphaVent Suture Anchors

Applicant Stryker Endoscopy

K-Number K231093

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DSP 2023-08-30

AC3 Series IABP

Applicant Arrow International, LLC

K-Number K232343

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LNH 2023-08-30

Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR

Applicant Canon Medical Systems Corporation

K-Number K230355

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JWY 2023-08-30

Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dalbavancin in the dilution range of 0.0005-2µg/ml

Applicant Thermo Fisher Scientific

K-Number K231988

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BTR 2023-08-30

Shiley Pediatric Oral/Nasal Endotracheal Tube with TaperGuard Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160)

Applicant Covidien

K-Number K223130

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PZX 2023-08-30

LAA Exclusion System

Applicant Syntheon, LLC

K-Number K232295

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DQY 2023-08-30

Ventrax Delivery System (VTR851)

Applicant Merit Medical Systems, Inc.

K-Number K231246

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DQA 2023-08-29

circul pro Ring

Applicant Bodimetrics, LLC

K-Number K221361

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PHX 2023-08-29

ARROW Off-Centred Humeral Insert

Applicant FH Industrie

K-Number K232226

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FZP 2023-08-29

LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320)

Applicant Ethicon Endo Surgery, LLC

K-Number K232313

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HIF 2023-08-29

StarFin

Applicant Premium Medical Technology, LLC

K-Number K231407

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