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U.S. Department of Health and Human Services

MAUDE - Manufacturer and User Facility Device Experience

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Super Search Devices@FDA
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 .018 DIGITAL IVUS CATHETER 04/22/2024
VOLCANO CORPORATION VISIONS PV .018 DIGITAL IVUS CATHETER 03/13/2024
BOSTON SCIENTIFIC CORPORATION OPTICROSS HD 03/01/2024
VOLCANO CORPORATION VISIONS PV .014P RX DIGITAL IVUS CATHETE 02/29/2024
VOLCANO CORPORATION VISIONS PV .018 DIGITAL IVUS IMAGING CAT 02/29/2024
ARROW INTERNATIONAL LLC ARROW(R) VPS(R) ACCESS KIT 02/12/2024
VOLCANO CORPORATION VISIONS PV .018 DIGITAL IVUS CATHETER 12/22/2023
VOLCANO CORPORATION EAGLE EYE PLATINUM ST RX DIGITAL IVUS CA 12/22/2023
VOLCANO CORPORATION VISIONS PV .035 DIGITAL IVUS CATHETER 11/17/2023
VOLCANO CORPORATION EAGLE EYE PLATINUM ST RX DIGITAL IVUS CA 11/09/2023
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