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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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124 records meeting your search criteria returned- Product Code: GCJ Product Problem: Air Leak Report Date From: 01/1/2015
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ManufacturerBrand NameDate Report Received
APPLIED MEDICAL RESOURCES C0R47, 12X100 KII BALLOON BLUNT TIP 6/BX 05/23/2018
APPLIED MEDICAL RESOURCES C0R47, 12X100 KII BALLOON BLUNT TIP 6/BX 01/31/2018
ETHICON ENDO-SURGERY, LLC. ENDOPATH XCEL 10/24/2017
MAQUET CV BOM 7MM EXTENDED LENGTH ENDOSCOPE 07/24/2017
ETHICON ENDO-SURGERY, LLC. BLADELESS TROCAR 12MM 06/01/2017
ETHICON ENDO-SURGERY, LLC. DEXTRUS HAND ACCESS SYSTEM 05/17/2017
COVIDIEN, FORMERLY USSC PUERTO RICO INC SPACEMAKER BLUNT TIP TROCAR 10MM 03/03/2017
COVIDIEN VERSAPORT V2 BLADELESS OPT 12 03/03/2017
COVIDIEN VERSAPORT V2 OPT BLADELESS 12 SHORT 03/03/2017
COVIDIEN VERSAPORT V2 BLADELESS OPT 12 02/21/2017
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