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
Pms Gmbh
Tuttlingen , DE NOL-DO 112-8787550-6/1/2
86H--NC 704754804847 SPECULA
01-NOV-2007 NOT LISTED
Pms Gmbh
Tuttlingen , DE NOL-DO 112-8787550-6/1/1
86H--NR 704754804847 FORCEPS
01-NOV-2007 NOT LISTED
Hagenmeyer Gerateb
Raisting , DE 82399 NOL-DO 112-8782064-3/1/1
87J--DS 862807031462/LOCKING SCREW
01-NOV-2007 NOT LISTED
NO 510(K)
Hagenmeyer Gerateb
Raisting , DE 82399 NOL-DO 112-8782064-3/2/1
87H--RS 862807031462/ORTHOPEDIC PLATE
02-NOV-2007 NOT LISTED
NO 510(K)
Vitalize Health Products Ltd
Surbiton GB-SRY, GB KT58LQ NOL-DO 112-8741218-5/1/1B
53LC-03 857073611011 Revitalizing Treatment and Night Cream
05-NOV-2007 COSM COLOR
Cermak
Pforceim , DE NOL-DO 112-8794926-9/1/1
95L--22 850977923247.LASERPOINTER
05-NOV-2007 NON STD
Arca Medica
Neuenburg , DE 79395 NOL-DO 112-8826283-7/1/1
79G--DI 942922144150 RETROSECTOR
05-NOV-2007 NOT LISTED
Arca Medica
Neuenburg , DE 79395 NOL-DO 112-8826283-7/2/1
87M--OO 942922144150 IMPLANT
05-NOV-2007 NOT LISTED
NO 510(K)
MSE Pharmazeutika GmbH
Bad Homburg DE-HE, DE 61352 PHI-DO 110-0282295-1/1/1
54AAC99 SANOMIT Q-10
06-NOV-2007 NO ENGLISH
Long Time Liner
Zurich , DE NOL-DO 112-8853665-1/1/1
53CD-07 859020952291 EYEBROW COLOUR
07-NOV-2007 UNSAFE COL
CSTIC LBLG
Long Time Liner
Zurich , DE NOL-DO 112-8853665-1/2/1
53GD-05 859020952295 LIP COLOUR
07-NOV-2007 UNSAFE COL
CSTIC LBLG
Long Time Liner
Zurich , DE NOL-DO 112-8853665-1/5/1
60QDK67 859020952291 LIDOCAINE
07-NOV-2007 NOT LISTED
UNAPPROVED
Long Time Liner
Zurich , DE NOL-DO 112-8853665-1/4/2
53GD-05 859020952291 LIP COLOUR
07-NOV-2007 UNSAFE COL
CSTIC LBLG
Long Time Liner
Zurich , DE NOL-DO 112-8853665-1/4/1
53CD-02 859020952291 LTL PENCIL
07-NOV-2007 UNSAFE COL
CSTIC LBLG
Indigodental
Bliedersdorf , DE 22547 NOL-DO 112-8855795-4/1/1
76E--MA 636830569009/DENTAL CEMENT/5G
07-NOV-2007 NOT LISTED
Indigodental
Bliedersdorf , DE 22547 NOL-DO 112-8855795-4/2/1
76E--JI 636830569009/SYRINGE
07-NOV-2007 NOT LISTED
Grunenthal
Aachenaachen , DE 52099 CIN-DO 110-0629657-4/1/1
60LIY69 TRAMAL, TRANSMITTING TO FDA DUE TO CUSTOMS REJECT, NO RX OR
13-NOV-2007 UNAPPROVED
Physo-M Punkt
Haibach , DE 63808 LOS-DO WIG-4041168-6/1/1
89M--PH BODYFORMER MACHINE (MUSCLE STIMULATION APPARATUS)
15-NOV-2007 REGISTERED
The Stevens Co Ltd Bc Division
Delta BC, CA V4G1J6 SEA-DO 110-0840009-1/1/1
85H--DF MEDICAL INSTRUMENTS GRAVES LEEP VAG SPEC
21-NOV-2007 NOT LISTED