Refusal Actions by FDA as Recorded in OASIS for Japan
Manufacture Name
City / Country or region District Entry/Doc/Line/Suffix
Product Code Product Description
Date Reason
Pentax Corporation
Tokyo , JP 1234 DET-DO 110-0804511-0/1/1
77E--OB Rhinolaryngoscope
03-DEC-2007 REGISTERED
Takamatsumachinery Co.,Ltd.
Ishikawaishikawa , JP 9208681 CHI-DO 286-4476891-4/2/1
95L--22 LASER SENSOR
04-DEC-2007 NO REGISTR
Kumamotoken Kajitsu Nogyo Kyodo Kumiami
Kumamoto , JP SAN-DO 427-2300576-7/15/2
31AFT99 COFFEE
05-DEC-2007 NEEDS FCE
NO PROCESS
Kumamotoken Kajitsu Nogyo Kyodo Kumiami
Kumamoto , JP SAN-DO 427-2300576-7/15/3
31AFT99 coffee
05-DEC-2007 NEEDS FCE
NO PROCESS
Daison Industries Co Ltd
Hiroshima-Ken , JP 739-8501 SEA-DO ANP-0008774-3/300/1
76E--FW TRAVELERS TOOTH BRUSH
05-DEC-2007 NOT LISTED
Daison Industries Co Ltd
Hiroshima-Ken , JP 739-8501 SEA-DO ANP-0008774-3/333/1A
89M--LX EMERGENCY PLASTER
05-DEC-2007 NOT LISTED
Daison Industries Co Ltd
Hiroshima-Ken , JP 739-8501 SEA-DO ANP-0008774-3/333/1B
79G--EM Gause/Bandages
05-DEC-2007 NOT LISTED
Daison Industries Co Ltd
Hiroshima-Ken , JP 739-8501 SEA-DO ANP-0008774-3/333/1C
89I--OY Ankle, Knee, Elbow & Wrist Supports
05-DEC-2007 NOT LISTED
Daison Industries Co Ltd
Hiroshima-Ken , JP 739-8501 SEA-DO ANP-0008774-3/339/1
63RBY99 TOOTHPASTE 4 PIECES
05-DEC-2007 NOT LISTED
Daison Industries Co Ltd
Hiroshima-Ken , JP 739-8501 SEA-DO ANP-0008774-3/536/1
76E--FW TOOTH BRUSH PORTABLE TRAVEL SET
05-DEC-2007 NOT LISTED
Shimadzu Corporation
Chiyoda Ku Tokyo, JP 101 FLA-DO MC2-6013989-4/1/1
90J--AK SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION;;
06-DEC-2007 NON STD
Shimadzu Corporation
Chiyoda Ku Tokyo, JP 101 FLA-DO MC2-6013989-4/2/1
90K--PS ACCESSORIES FOR X RAY CT SCANNER - TOMOGRAPHY COMPUTED EMISS
06-DEC-2007 NON STD
Kanebo Cosmetics Inc
Tokyo , JP 106-8085 SAN-DO 427-2198779-2/3/5
66VAY99 Unknown Sunscreen
12-DEC-2007 DIRSEXMPT
Kanebo Cosmetics Inc
Tokyo , JP 106-8085 SAN-DO 427-2198779-2/3/6
66VAY99 Unknown Sunscreen
12-DEC-2007 DIRSEXMPT
Kanebo Cosmetics Inc
Tokyo , JP 106-8085 SAN-DO 427-2198779-2/3/14
66VAY99 unknown sunscreen
12-DEC-2007 DIRSEXMPT
Kanebo Cosmetics Inc
Tokyo , JP 106-8085 SAN-DO 427-2198779-2/3/15
66VAY99 Unknown Sunscreen
12-DEC-2007 DIRSEXMPT
Kanebo Cosmetics Inc
Tokyo , JP 106-8085 SAN-DO 427-2198779-2/3/17
66VAY99 Unknown sunscreen
12-DEC-2007 DIRSEXMPT
Hotei Food Corporation Fujikawa Pla
Fujikawa-Cho , JP NYK-DO 554-5273271-6/4/1
31KGE04 JASMINE TEA DRINK
13-DEC-2007 NO PROCESS
Jms Co., Ltd.
Hiroshima , JP 730 FLA-DO EE6-2015816-6/1/1
79G--AJ DISPOSABLE VIN STRIPPER / FOR EXPORTS ONLY
17-DEC-2007 NOT LISTED
NO 510(K)
Daison Industries Co Ltd
Hiroshima-Ken , JP 739-8501 SEA-DO ANP-0008907-9/18/1A
76L--CN Tongue Cleaner
17-DEC-2007 NOT LISTED
Daison Industries Co Ltd
Hiroshima-Ken , JP 739-8501 SEA-DO ANP-0008907-9/18/1B
89M--LX Leg and Waist Heating Sheets w/-ve Ions
17-DEC-2007 NOT LISTED
Daison Industries Co Ltd
Hiroshima-Ken , JP 739-8501 SEA-DO ANP-0008907-9/18/1C
89M--LX Knee, ankle, calve, palm, thigh, elbow supporters
17-DEC-2007 NOT LISTED
Nipro Corporation
Osaka , JP FLA-DO FR1-0012073-7/1/1
78F--KP DIALYSIS MACHINE FOR EXPORT ONLY
20-DEC-2007 REGISTERED
Nipro Corporation
Osaka , JP FLA-DO FR1-0012073-7/2/1
80F--RN INFUSION PUMP FOR EXPORT ONLY
20-DEC-2007 REGISTERED
NO 510(K)
Imuraya Seika Co
Takajyaya Mie, JP SAN-DO 597-0149835-0/7/2
37BGT99 SWEET RED BEAN
22-DEC-2007 LIST INGRE
NEEDS FCE
NO PROCESS
Nozaki Tsukemono Co Ltd
Miyazaki , JP LOS-DO 224-4306974-9/30/3
25JGP27 SALTED RADISH 30BG X5.6OZ
27-DEC-2007 UNSAFE ADD