Refusal Actions by FDA as Recorded in OASIS for Denmark

   Manufacture Name
   City / Country or region                      District  Entry/Doc/Line/Suffix
   Product Code        Product Description
                          Date                             Reason
Danamedic Klampenborgklampenborg , DK 2930 CIN-DO UPS-1100216-7/1/1 78L--KY COMP FOR EXTERNAL PENILE RIGIDITY DEVICE,PERSONAL,DELV RICHA 10-JUN-2008 DIRECTIONS REGISTERED Danamedic Klampenborgklampenborg , DK 2930 CIN-DO UPS-1100309-0/1/1 78L--KY COMPONENT PARTS FOR EXTERNAL PENILE RIGIDITY DEVICE: SPONGES 10-JUN-2008 DIRECTIONS REGISTERED Danamedic Klampenborgklampenborg , DK 2930 CIN-DO UPS-1098278-1/1/1 78L--KY COMP ONLY FOR EXTERNAL PENILE DEVICE,PERSONAL,DELV JOHN LEWI 10-JUN-2008 DIRECTIONS Ssi Diagnostica Hilleroed , DK NOL-DO 112-3040346-4/1/1 82D--FJ 957661278921 Antigen from Pneumococci (Various? Antisera) 11-JUN-2008 NOT LISTED NO 510(K) Danamedic Aps Klampenborg , DK 2930 PHI-DO UPS-1170984-5/1/1 78L--KY Jes-Extender 11-JUN-2008 DIRECTIONS REGISTERED NO 510(K) Danamedic Aps Klampenborg , DK 2930 PHI-DO UPS-1170989-4/1/1 78L--KY Jes-Extender 11-JUN-2008 DIRECTIONS REGISTERED NO 510(K) William Cook Europe ApS Bjaeverskov , DK DK-4632 NYK-DO 112-2794036-1/1/1 84N--JE 633975437227 INTRACRANIAL STENTS 12-JUN-2008 NOT LISTED REGISTERED NO 510(K) Danamedic Klampenborgklampenborg , DK 2930 CIN-DO UPS-1161534-9/1/1 78L--KY PART-DEVICE, EXTERNAL PENILE RIGIDITY/FOR INDIVIDUAL/DELV ER 12-JUN-2008 DIRECTIONS Danamedic Klampenborgklampenborg , DK 2930 CIN-DO UPS-1251375-8/1/1 78L--KY ERR/CBP/JES-EXTENDER/PENILE ENLARGER DEVICE/DELV GREG CHRIST 18-JUN-2008 DIRECTIONS REGISTERED Danamedic Klampenborgklampenborg , DK 2930 CIN-DO UPS-0953849-5/1/1 78L--KY JES-EXTENDER TO ENLARGE PENIS BY TRACTION 25-JUN-2008 DIRECTIONS REGISTERED Danamedic Klampenborgklampenborg , DK 2930 CIN-DO UPS-0953807-3/1/1 78L--KY JES-EXTENDER USED TO ENLARGE THE PENIS BY TRACTION 25-JUN-2008 DIRECTIONS REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/2/1 76E--IF SCREWDRIVER MANUAL BALL ABUTMENT 22 MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/6/1 76N--HA ABUTMENT REPLICA MULTI-UNIT 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/7/1 76E--IF DIRECTION INDICATOR 2/ 2.4-2.8MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/13/1 76E--IF GUIDE PIN IMPL LEV SELECT NP 20 MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/14/1 76E--CT IMPL DRIVER WRENCH ADAP BMK SYST NP 21MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/14/2 76E--IF ZYGOMA SURGICAL KIT 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/14/3 76E--CT IMPLANT DRIVER BMK SYST NP 26 MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/14/4 76E--IF SCREWDRIVER MACHINE UNIGRIP 25 MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/16/2 76E--IF SCREWDRIVER MACHINE UNIGRIP 35 MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/20/1 76E--IF ALL-ON-4 GUIDE 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/24/1 76E--IF BONE MILL WITH GUIDE NOBRPL 6.0 7 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/24/2 76N--HA BONE MILL GUIDE BMK SYST RP 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/38/1 76E--IF GUIDE PIN IMPL LEV SELECT RP/WP 30 MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/43/1 76E--IF IMPRESSION COPING OPEN TRAY MULTI-UNIT 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/44/1 76E--IF MANUAL TORQUE WRENCH ADAPTER SURGICAL 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/44/2 76E--IF SCREWDRIVER MACHINE BALL ABUTMENT 24 MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/44/3 76E--IF DRILL STOP 3 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/44/4 76E--IF NOBELACTIVE MAN TORQUE WRENCH SURGICAL 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/48/1 76E--IF IMPR COPING OPEN TRAY M-U BMK SYST WP 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/49/1 76E--IF HANDLE FOR MACHINE INSTRUMENTS 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/49/2 76E--CT IMPL DRIVER WRENCH ADAP BMK SYST RP 21MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/49/3 76E--IF GUIDE SLEEVE BR NEMARK SYSTEMR RP 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/54/1 76E--IF MANUAL TORQUE WRENCH ADAPTER SURGICAL 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/59/1 76E--IF GUIDED DRILL GUIDE 6.0/WP TO 2MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/74/1 76E--IF DIRECTION INDICATOR 2/ 2.4-2.8MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/75/1 76E--IF SCREWDRIVER MANUAL UNIGRIP 28 MM 30-JUN-2008 NOT LISTED REGISTERED