Refusal Actions by FDA as Recorded in OASIS for Germany
Manufacture Name
City / Country or region District Entry/Doc/Line/Suffix
Product Code Product Description
Date Reason
Gefra
Berlin , DE BLT-DO 605-2523663-8/15/1
66VBY99 Glycerin Cream
01-OCT-2008 NOT LISTED
DIRECTIONS
LACKS N/C
Syntacoll Gmbh
Saal Donau , DE NOL-DO 112-4534164-2/1/1
56DKY20 978721138201 COLLAGEN GENTAMICIN
02-OCT-2008 NEW VET DR
Linde Eckstein Gmbh + Co KG
Oberasbach , DE LOS-DO 267-5144802-3/8/1
66PBL99 SUN ACTIVE MILK SPF 20
02-OCT-2008 NOT LISTED
UNAPPROVED
Linde Eckstein Gmbh + Co KG
Oberasbach , DE LOS-DO 267-5144802-3/8/2
65LBL11 SUN CREAM SPF 30
02-OCT-2008 NOT LISTED
UNAPPROVED
Dentsply Ldc
Radolfzellradolfzell , DE 78315 FLA-DO WMV-0374031-4/1/1
76E--LW IMPRESSION MATERIAL
10-OCT-2008 REGISTERED
Dentsply Ldc
Radolfzellradolfzell , DE 78315 FLA-DO WMV-0374031-4/1/2
76E--LW IMPRESSION MATERIAL
10-OCT-2008 REGISTERED
Dentsply Ldc
Radolfzellradolfzell , DE 78315 FLA-DO WMV-0374031-4/2/1
76E--BF TOOTH SHADE RESIN
10-OCT-2008 REGISTERED
Dentsply Ldc
Radolfzellradolfzell , DE 78315 FLA-DO WMV-0374031-4/3/1
76L--BH VARNISH CAVITY
10-OCT-2008 REGISTERED
Dentsply Ldc
Radolfzellradolfzell , DE 78315 FLA-DO WMV-0374031-4/4/1
76E--MA DENTAL CEMENT
10-OCT-2008 REGISTERED
Dentsply Ldc
Radolfzellradolfzell , DE 78315 FLA-DO WMV-0374031-4/5/1
76K--IF DENTAL CANAL SEALER
10-OCT-2008 REGISTERED
Dentsply Ldc
Radolfzellradolfzell , DE 78315 FLA-DO WMV-0374031-4/6/1
76E--MA DENTAL CEMENT
10-OCT-2008 REGISTERED
Dentsply Ldc
Radolfzellradolfzell , DE 78315 FLA-DO WMV-0374031-4/7/1
76D--YH ADHESIVE BRACKET AND TOOTH CONDITIONER
10-OCT-2008 REGISTERED
Dentsply Ldc
Radolfzellradolfzell , DE 78315 FLA-DO WMV-0374031-4/8/1
76E--MA RESIN CEMENT
10-OCT-2008 REGISTERED
Dentsply Ldc
Radolfzellradolfzell , DE 78315 FLA-DO WMV-0374031-4/9/1
76E--LW IMPRESSION MATERIAL
10-OCT-2008 REGISTERED
Rz Medizintech Gmbh
Tuttlingen , DE 78532 FLA-DO K51-0065299-6/1/1
78F--BQ TROCAR-FOR EXPORT ONLY
14-OCT-2008 REGISTERED
Rz Medizintech Gmbh
Tuttlingen , DE 78532 FLA-DO K51-0065299-6/1/2
78F--CL FORCEPS-FOR EXPORT ONLY
14-OCT-2008 REGISTERED
Rz Medizintech Gmbh
Tuttlingen , DE 78532 FLA-DO K51-0065299-6/1/3
78F--AJ CYSTOSCOPE-FOR EXPORT ONLY
14-OCT-2008 REGISTERED
Rz Medizintech Gmbh
Tuttlingen , DE 78532 FLA-DO K51-0065299-6/1/4
79F--ST FIBEROPTIC LIGHT-FOR EXPORT ONLY
14-OCT-2008 REGISTERED
Rz Medizintech Gmbh
Tuttlingen , DE 78532 FLA-DO K51-0065299-6/1/5
78F--FN CLAMP
14-OCT-2008 REGISTERED
Rz Medizintech Gmbh
Tuttlingen , DE 78532 FLA-DO K51-0065299-6/1/6
78F--JL RESECTOSCOPE-FOR EXPORT ONLY
14-OCT-2008 REGISTERED
Rz Medizintech Gmbh
Tuttlingen , DE 78532 FLA-DO K51-0065299-6/1/7
85H--IH HYSTEROSCOPE-FOR EXPORT ONLY
14-OCT-2008 REGISTERED
Rz Medizintech Gmbh
Tuttlingen , DE 78532 FLA-DO K51-0065304-4/1/1
78E--ZN URETERAL BALLOON DILATOR
14-OCT-2008 NOT LISTED
Rz Medizintech Gmbh
Tuttlingen , DE 78532 FLA-DO K51-0065304-4/1/2
78F--FL STONE BASKET
14-OCT-2008 NOT LISTED
Metrax Gmbh
Rottweil , DE D-78628 FLA-DO DM9-8011123-9/1/1
74M--KJ PRIMEDIC DEFIMONITOR XD30 FOR EXPORT ONLY
20-OCT-2008 NOT LISTED
Sankt Hubertus Studienbuero
Berlin , DE 10587 NYK-DO DO7-8203330-5/1/1
66VIE99 RETIGABINE
22-OCT-2008 UNAPPROVED
Medsolution
Radolfzell , DE CIN-DO UPS-2611065-8/1/1
84N--YX LED Light with Electrical stimulator for Aesthetic purposes.
23-OCT-2008 NOT LISTED
REGISTERED
NO 510(K)
Eppendorf Geratebau Netheler + Hinz Gmbh
Hamburg , DE 22339 FLA-DO EQ6-0008333-9/1/1
80L--DQ LAB EQ FDA WE NEED REFUSAL NOTICE A.S.A.P. CARGO IS FOR EXPO
27-OCT-2008 REGISTERED
Rz Medizintech Gmbh
Tuttlingen , DE 78532 FLA-DO K51-0065298-8/1/1
78E--ZN URETERAL DIALATOR-FOR EXPORT ONLY
31-OCT-2008 NOT LISTED
REGISTERED
Rz Medizintech Gmbh
Tuttlingen , DE 78532 FLA-DO K51-0065298-8/1/2
78F--FL URETERAL STONE BASKET-FOR EXPORT ONLY
31-OCT-2008 NOT LISTED
REGISTERED