Refusal Actions by FDA as Recorded in OASIS for Sweden

   Manufacture Name
   City / Country or region                      District  Entry/Doc/Line/Suffix
   Product Code        Product Description
                          Date                             Reason
Astrazeneca Sverige Ab Sodertalje , SE NOL-DO 112-2814680-2/1/1 61EQQ04 865810448660 SYMBICORT 80 MCG 09-JUN-2008 UNAPPROVED Aerosol Scandinavia Ab Vallentuna , SE 18632 PHI-DO KH5-0033632-7/1/1 61WDQ28 TERSI FOAM 75ML; NDC#23710-225-20 18-JUN-2008 UNAPPROVED Aerosol Scandinavia Ab Vallentuna , SE 18632 BLT-DO KH5-0034191-3/1/1 61SDQ99 DESI PRODUCT; NDC#23710-040-20;23710-040-75 25-JUN-2008 UNAPPROVED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/3/1 76E--IF GOLD CYLINDER CERAONE NP/RP 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/4/1 76N--HA TEMP ABUTM ENGAGING BR NEMARK SYSTEMR NP 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/4/2 76N--HA HEALING ABUTMENT BMK SYST NP 4X4 MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/4/3 76N--HA BR NEMARK SYSTEM MK IV TIU RP 4.0X18MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/4/4 76N--HA TEMPORARY COPING MULTI-UNIT BMK SYST WP 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/11/1 76N--HA IMMEDIATE TEMP ABUTM BR NEMARK SYSTEM RP 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/11/2 76E--IF NOBELDIRECTR GROOVY RP 4.3X13MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/17/1 76E--IF HEALING CAP MULTI-UNIT 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/17/2 76N--HA SCREW CERAMIC ABUTMENT BMK SYST RP 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/21/1 76N--HA BR NEMARK SYST MK III GROOVY NP 3.3X13MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/21/2 76N--HA ABUTMENT SCREW OCTAGON TI 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/21/3 76N--HA BALL ABUTMENT TITANIUM BMK SYST RP 3 MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/28/1 76E--IF GOLD CYLINDER 3 MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/29/1 76N--HA BMK SYST ZYGOMA ABUTMENT SCREW 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/29/2 76N--HA 30° MULTI-U ABUTM NON-ENG NOBRPL RP 4MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/29/3 76N--HA HEALING ABUTMENT BMK SYST NP 4.5X3MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/29/4 76N--HA ABUTMENT COMPLETE ESTHETICONE 3 MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/29/5 76N--HA 30° MULTI-U ABUT NON-ENG BMK SYST RP 5MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/29/6 76N--HA ABUTMENT SCREW TI FOR CAMLOG 3.3/3.8/4.3 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/33/1 76N--HA ESTHETIC ABUTMENT BMK SYST NP 2MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/33/2 76N--HA BMK SYST ZYGOMA HEALING ABUTMENT 4X5MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/34/1 76D--ZL SCREW TAP NP 10-15MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/40/1 76N--HA IMMEDIATE TEMP ABUTM BR NEMARK SYSTEM NP 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/40/2 76N--HA SCREW CERAMIC ABUTMENT BMK SYST NP 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/40/3 76D--ZL LAB SCREW MULTI-UNIT 5/PKG 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/40/4 76N--HA 17º MULTI-UNIT ABUTMENT SELECT RP 4 MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/40/5 76N--HA HEALING CAP WIDE MULTI-UNIT 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/40/6 76E--IF PROSTHETIC SCREW MULTI-UNIT BMK SYST WP 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/40/7 76N--HA ABUTMENT SCREW BR NEMARK SYSTEMR NP 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/45/1 76E--IF ARK ANCHOR PIN 1.5 MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/47/1 76N--HA MULTI-UNIT ABUTMENT BMK SYST RP 5 MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/47/2 76N--HA MULTI-UNIT ABUTMENT BMK SYST NP 3 MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/52/1 76N--HA MULTI-UNIT ABUTMENT BMK SYST NP 2 MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/52/2 76N--HA SCREW MULTI-UNIT ANG ABUTM BMK SYST RP 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/52/3 76E--IF IMPRESSION COPING BAR BMK SYST RP 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/52/4 76N--HA 17º MULTI-UNIT ABUTMENT BMK SYST NP 2 MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/52/5 76N--HA MULTI-UNIT ABUTMENT SELECT NP 1 MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/55/1 76E--IF ZYGOMA IMPLANT RP 52.5MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/55/2 76N--HA SCREW CERAMIC ABUTMENT SELECT RP/WP 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/55/3 76D--ZL REPLACE SELECT STRAIGHT TIU 3MMRP 4.3X15 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/61/1 76E--IF NOBELDIRECTR GROOVY NP 3.5X10MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/61/2 76N--HA GUIDED ABUTMENT NOBRPL NP 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/61/3 76N--HA BALL ABUTMENT TITANIUM BMK SYST RP 4 MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/62/1 76D--ZL SCREW TAP RP 4 7-13MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/76/1 76E--IF DEPTH PROBE 30-JUN-2008 NOT LISTED REGISTERED