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U.S. Department of Health and Human Services

Import Refusal Report

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Refusal Actions by FDA as Recorded in OASIS

for 74-Cardiovascular

Entry/doc/line/sfx Refusal Date Product
112-2348515-7/1/1 28-Oct-2011 74DQA 3003768251 Philips Medical Systems Gmbh, DMC Germany
UPS-3556170-9/2/3 06-Oct-2011 74DQF 3009107637 Leonelia Izquierdo Colombia
UPS-3718368-4/5/1 07-Oct-2011 74DQF 3009127109 Pharmasave Health Centre #009 Canada
112-9220083-2/1/2 28-Oct-2011 74DQO 3009600098 St. Jude Medical, CATD Westford United States
112-3510677-5/1/1 18-Oct-2011 74DQY 3008365899 Rhenus Netherlands
FR1-0014047-9/1/1 20-Oct-2011 74DTR 3002533790 Nipro Medical Ltda Brazil
H41-7004669-6/2/1 05-Oct-2011 74DXN 3009061607 Norav Medical Gmbh Germany
406-0465366-3/1/1 26-Oct-2011 74DXN 3006704335 Panasonic Electric Works Wanbao China
BJZ-0209968-4/1/1 10-Oct-2011 74DXQ 3008619984 Genexel Medical Instruments Inc Korea, Republic Of (South)
DM9-1101173-0/1/1 20-Oct-2011 74DXT 3008024630 Mgt Nemoto International Belgium
112-3551463-0/1/1 24-Oct-2011 74KRD 3007515539 Alam Medical France
EI5-2480636-7/4/1 18-Oct-2011 74NIK 3001123577 Heartland Appliances Canada
112-9288231-6/1/1 28-Oct-2011 74NKE 3007875784 Hirel Systems Inc United States
112-9552808-1/1/1 18-Oct-2011 74OFI 3008707277 Mechatronic Ag Germany