Refusal Actions by FDA as Recorded in OASIS for Switzerland

   Manufacture Name
   City / Country or region                      District  Entry/Doc/Line/Suffix
   Product Code        Product Description
                          Date                             Reason
Marflow Ag Adliswil , CH 8134 FLA-DO MC2-6059041-9/1/1 74M--AF URETHERAL STENTZ 02-JUN-2008 REGISTERED NO 510(K) Marflow Ag Adliswil , CH 8134 FLA-DO MC2-6059041-9/2/1 79G--BO URETHERAL CATHETER 02-JUN-2008 REGISTERED NO 510(K) Marflow Ag Adliswil , CH 8134 FLA-DO MC2-6059041-9/3/1 74O--FB CATHETER GUIDE WIRE KIT;; 02-JUN-2008 REGISTERED NO 510(K) Marflow Ag Adliswil , CH 8134 FLA-DO MC2-6059041-9/3/2 79G--EN FORCEPS, GENERAL & PLASTIC SURGERY;; 02-JUN-2008 REGISTERED NO 510(K) Marflow Ag Adliswil , CH 8134 FLA-DO MC2-6059041-9/3/3 79G--CC DILATOR, CATHETER;; 02-JUN-2008 REGISTERED NO 510(K) Marflow Ag Adliswil , CH 8134 FLA-DO MC2-6059041-9/4/1 79G--CB NEEDLE, CATHETER;; 02-JUN-2008 REGISTERED NO 510(K) Markus Fluehmann A Zuerich-Meren , CH NOL-DO 112-3015436-4/1/1 34FFT02 946575851262-CHOCOLATE 13-JUN-2008 LIST INGRE LACKS FIRM Paschke Meditrade Huenenberg , CH SWI-DO GH5-0037731-8/1/1 86K--YG Portable Medical Opto-Electronic Device UV-X Illumination Sy 16-JUN-2008 NOT LISTED REGISTERED Medika Ag Aesch , CH 4147 NOL-DO 112-3127915-2/1/1 56KCH85 852182831128/VANCOCIN HCL 250 MG 24-JUN-2008 UNAPPROVED Sanofi Synthelabo Meyrin , CH 1217 NOL-DO 112-3127915-2/2/1 60SAA99 852182831128/BIOFLORIN 24-JUN-2008 UNAPPROVED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/1/1 76N--HA GOLDADAPT ENGAGING BR NEMARK SYSTEMR NP 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/1/2 76E--IF GOLD CYL MULTI-UNIT WITH SCREW 5/PKG 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/5/1 76E--IF GUIDED TWIST DRILL TAPER 2X(10+)8-16MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/5/2 76E--IF GUIDED TWIST DRILL 1.5MMX20MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/5/3 76E--IF GUIDED SCREW TAP RP 3.75 7-13MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/5/4 76D--ZA TWIST STEP DRILL 2.4/2.8 10-18MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/5/5 76E--IF GUIDED SCREW TAP RP 4 7-13MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/5/6 76D--ZA BMK SYST ZYGOMA TWIST DRILL 2.9 MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/12/1 76D--ZL SCREW TAP REPL SLCT STRAIGHT NP 10-15 MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/12/2 76D--ZA DRILL KIT 7-15MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/12/3 76D--ZA DRILL WITH TIP STRAIGHT 2X7-15 MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/18/1 76D--ZA TWIST STEP DRILL 3.2/3.6 10-18MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/22/1 76D--ZA TWIST STEP DRILL 4.2/4.6 7-15MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/22/2 76D--ZA TWIST DRILL 3.15 MM 7-15 MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/30/1 76D--ZA TWIST STEP DRILL 3.8/4.2 7-15MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/35/1 76N--HA GOLDADAPT ENGAGING NOBRPL 6.0 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/36/1 76D--ZA TWIST DRILL 1.5X7-15MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/41/1 76D--ZA TWIST DRILL 2 MM 13-20 MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/41/2 76E--IF BR NEMARK SYSTEMR ZYGOMA ROUND BUR 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/41/3 76D--ZA TWIST STEP DRILL 2.4/2.8 7-15MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/41/4 76E--IF SCREWDRIVER/ACTIVATOR 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/42/1 76E--IF GOLD CYLINDER MULTI-UNIT WITH SCREW 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/53/1 76D--ZA TREPHINE DRILL 3.8/4.6 MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/53/2 76D--ZA COUNTERSINK MK IV SHORT RP 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/53/3 76D--ZA TWIST DRILL 2.7 MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/53/4 76D--ZA SCREW TAP MK IV RP 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/56/1 76D--ZA SCREW TAP MK III RP 7-18 MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/56/2 76E--IF SCREW TAP REPAIR BR NEMARK SYSTEMR RP 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/57/1 76E--IF GUIDED START DRILL/COUNTERB BMK SYST NP 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/57/2 76E--IF GUIDED SCREW TAP 6.0/WP 6 7-13MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/57/3 76E--IF GUIDED TWIST DRILL 2X(10+)7-13MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/57/4 76D--ZL SCREW TAP RP 4 7-13MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/73/1 76D--ZA DRILL KIT LONG SHAFT 7-15 MM 30-JUN-2008 NOT LISTED REGISTERED