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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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5 records meeting your search criteria returned- Product Code: DTZ Product Problem: Material Split, Cut or Torn Report Date From: 01/1/2009
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ManufacturerBrand NameDate Report Received
TERUMO CARDIOVASCULAR SYSTEMS CORPORATIO NS FX25RWC W/RES 11/21/2023
TERUMO CARDIOVASCULAR SYSTEMS CORPORATIO STERILE FX25RWC W/ RES 11/29/2022
TERUMO CARDIOVASCULAR SYSTEMS CORPORATIO STERILE FX25REC W/RES 12/14/2021
TERUMO CORPORATION, ASHITAKA CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL 12/23/2019
PERFUSION SYSTEMS AFFINITY HFO W/TRILLIUM 511T 12/16/2019
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