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U.S. Department of Health and Human Services

Manufacturer and User Facility Device Experience (MAUDE)

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510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
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285 records meeting your search criteria returned- Product Code: OBJ Product Problem: Material Separation Report Date From: 01/1/2007

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ManufacturerBrand NameDate Report Received
VOLCANO CORPORATION VISIONS PV .014P RX DIGITAL IVUS CATHETE 10/06/2023
VOLCANO CORPORATION VISIONS PV .018 DIGITAL IVUS CATHETER 10/05/2023
VOLCANO CORPORATION EAGLE EYE PLATINUM ST RX DIGITAL IVUS CA 09/14/2023
VOLCANO CORPORATION EAGLE EYE PLATINUM RX DIGITAL IVUS CATHE 08/17/2023
VOLCANO CORPORATION VISIONS PV .035 DIGITAL IVUS CATHETER 08/14/2023
PHILIPS VOLCANO VISIONS PV .018 CATHETER 07/13/2023
PHILIPS VOLCANO VISIONS PV .014P RX 06/13/2023
PHILIPS VOLCANO VISIONS PV .035 (NON-HOSPITAL) 05/17/2023
PHILIPS VOLCANO VISIONS PV .018 CATHETER 03/10/2023
PHILIPS VOLCANO EAGLE EYE PLATINUM 03/10/2023
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