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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 80-General Hospital/Personal Use


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
AZK-7169135-4/6/1 02-Feb-2012 80FLL 3006631071 Bliss Technology C China
 
112-5493070-9/1/1 10-Feb-2012 80FMF 3006748072 Bd Diagnostics United States
 
UPS-6583440-3/1/1/A 06-Feb-2012 80FMI 3004858808 B D United States
 
UPS-6583440-3/1/1/B 06-Feb-2012 80FMI 3004858808 B D United States
 
FR1-0014216-0/1/1 13-Feb-2012 80FOZ 3004070915 Hanako Medical Japan
 
FR1-0014253-3/1/1 21-Feb-2012 80FOZ 3004070915 Hanako Medical Japan
 
FR1-0014255-8/1/1 21-Feb-2012 80FOZ 3004070915 Hanako Medical Japan
 
112-5754642-9/1/1 01-Feb-2012 80FQH 3007279404 Inex France
 
FR1-0014216-0/2/1 13-Feb-2012 80FRN 3007482089 Miyuki Elex Co.,Ltd Japan
 
FR1-0014253-3/3/1 21-Feb-2012 80FRN 3007482089 Miyuki Elex Co.,Ltd Japan
 
FR1-0014255-8/3/1 21-Feb-2012 80FRN 3007482089 Miyuki Elex Co.,Ltd Japan
 
CDF-2044521-2/2/1 07-Feb-2012 80FRW 1317256 Sr Instruments Inc United States
 
CDF-2044591-5/2/1 07-Feb-2012 80FRW 1317256 Sr Instruments Inc United States
 
CDF-2044521-2/1/1 07-Feb-2012 80FSA 3001345292 T H E Medical Canada
 
CDF-2044591-5/1/1 07-Feb-2012 80FSA 3001345292 T H E Medical Canada
 
224-0464909-1/14/1 15-Feb-2012 80FSA 1000334118 Merits Health Products Co., Ltd. Taiwan
 
224-0464909-1/14/2 15-Feb-2012 80FSA 1000334118 Merits Health Products Co., Ltd. Taiwan
 
T94-0056591-5/2/3 13-Feb-2012 80GAZ 1000157602 Medicon Instrumente Germany
 
AEK-8393422-0/1/1 15-Feb-2012 80JOK 3002914520 Solatch International Pakistan
 
UPS-4813879-2/1/1 01-Feb-2012 80KGX 3009084642 Millpledge Healthcare Supplies China
 
144-4765001-4/6/1 27-Feb-2012 80KGX 3008422216 Taizhou Zonrun Import Export China
 
UPS-4810842-3/2/1 13-Feb-2012 80KMI 3009292702 Sino-Hero(Shenzhen)Bio-Medical Hong Kong SAR
 
112-5662064-7/1/1 10-Feb-2012 80KYS 3009104289 Berkemann Gmbh Germany
 
T94-0056591-5/2/1 13-Feb-2012 80KZA 1000157602 Medicon Instrumente Germany
 
T94-0056591-5/3/4 13-Feb-2012 80LBI 1000157602 Medicon Instrumente Germany
 
EQ6-0014420-6/1/1 09-Feb-2012 80LDQ 5833 EPPENDORF AG Germany
 
112-5536674-7/1/1 10-Feb-2012 80LDQ 3009299193 Loktal Medical Ele Brazil
 
EB6-0242603-4/1/1 24-Feb-2012 80LDQ 3009314589 Kriosystem Sp. Zo. O. Poland
 
112-5598831-8/2/1 03-Feb-2012 80LJL 3008861123 Medisana Ag Germany
 
T76-0200941-9/1/1 01-Feb-2012 80LKB 3007140720 Sterilance Medical (Suzhou) Inc. China
 
FR1-0014247-5/1/1 21-Feb-2012 80LKB 3006403682 Jiangsu Province Jianerkang Medical Dressing Co. China
 
J86-0871030-9/5/1 27-Feb-2012 80LKB 3005721152 Planet Hong Kong International Company China
 
113-5723903-4/82/1 10-Feb-2012 80LZA 3002327142 Zhenjiang Kangda Emulsion Co,Ltd China
 
112-5585790-1/1/1/C 07-Feb-2012 80LZC 3005689707 Adventa Health Sdn Bhd Malaysia
 
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