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

DYG 2024-06-27

Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D97130F5); Swan-Ganz Pacing Thermodilution TD Catheter (D200F7); Chandler Transluminal V-Pacing Probe (D98100)

Applicant Edwards Lifesciences

K-Number K233983

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MBH 2024-06-27

The Optimotion Blue Plus Knee System

Applicant Optimotion Implants, LLC

K-Number K240938

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QQJ 2024-06-27

FSYX Ocular Pressure Adjusting Pump (FSYX OPAP) System

Applicant Balance Ophthalmics, Inc.

K-Number DEN230055

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FRC 2024-06-27

3M Attest Rapid Readout Biological Indicator 1295 and 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E

Applicant 3M Company

K-Number K240717

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HRS 2024-06-26

Forma Medical Optimal Plating System

Applicant Forma Medical, Inc.

K-Number K234059

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LNH 2024-06-26

Magnifico Open (100009900); Magnifico MSK ( 100009910)

Applicant Esaote, S.p.A.

K-Number K241133

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JWH 2024-06-26

Unity Knee PS-C Tibial Insert

Applicant Corin U.S.A. Limited

K-Number K240875

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DTK 2024-06-26

ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK)

Applicant Aln S.A.R.L.

K-Number K241507

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JAA 2024-06-26

TRIDENT Mobile Fluoroscopy System

Applicant Dornier Medtech America

K-Number K233380

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QBD 2024-06-26

Sample Preservative Fluid

Applicant Hangzhou Bioer Technology Co., Ltd.

K-Number K222771

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MWI 2024-06-26

WVSM Pro (Series) (500-0030-XX)

Applicant Athena Gtx, Inc.

K-Number K233354

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IYO 2024-06-26

SC1 Handheld Ultrasound Imaging system (Model: SC1)

Applicant Fcu Co., Ltd.

K-Number K233579

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