Company ยท US
Beiersdorf, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 2009. Name variants (Inc, Corp, punctuation) are merged.
48510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KGX | Tape And Bandage, Adhesive | 15 |
| FPX | Strip, Adhesive, Closure, Skin | 6 |
| FRO | Dressing, Wound, Drug | 6 |
| KMF | Bandage, Liquid | 3 |
| FQM | Bandage, Elastic | 2 |
| KOD | Catheter, Urological | 2 |
| MGP | Dressing, Wound And Burn, Occlusive | 2 |
| DWL | Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) | 1 |
| EZL | Catheter, Retention Type, Balloon | 1 |
| FZQ | Clip, Removable (Skin) | 1 |
| GBI | Material, External Aesthetic Restoration, Used With Adhesive | 1 |
| IRT | Pad, Heating, Powered | 1 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | 1 |
| KOZ | Beads, Hydrophilic, For Wound Exudate Absorption | 1 |
| LGF | Component, Cast | 1 |
| MDA | Elastomer, Silicone, For Scar Management | 1 |
| NAB | Gauze / Sponge,Nonresorbable For External Use | 1 |
| NAD | Dressing, Wound, Occlusive | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 18, 2009 | K090921 | ANTI-EMBOLISM STOCKINGS, MODELS 71055-00000-02, 71057-00000-02, 71059-00000-02, 71064-00000-02 & 71065-00000-02 Beiersdorf, Inc. | DWL |
| Feb 10, 2004 | K032463 | CURAD SILVER BANDAGE Beiersdorf AG | FRO |
| Feb 10, 2004 | K032462 | CURAD SILVER ACTIVE GEL BANDAGE Beiersdorf AG | FRO |
| Jun 18, 2003 | K024057 | CURAD SCAR THERAPY Beiersdorf, Inc. | MDA |
| Nov 5, 2002 | K022645 | CURAD Beiersdorf AG | KMF |
| Aug 14, 1995 | K952526 | CUTINOVA CAVITY Beiersdorf, Inc. | KMF |
| Mar 15, 1995 | K943363 | CUTIPLAST STERIL Beiersdorf, Inc. | MGP |
| Dec 2, 1994 | K944581 | CUTINOVA THIN WOUND DRESSING Beiersdorf, Inc. | KMF |
| Oct 7, 1994 | K935630 | NORTA Beiersdorf, Inc. | EZL |
| Jul 29, 1994 | K940378 | COVERLET ADHESIVE DRESSING Beiersdorf, Inc. | KGX |
| Feb 25, 1994 | K925630 | ELASTOPLAST HEAT PLASTER Beiersdorf, Inc. | IRT |
| Nov 15, 1993 | K926399 | CUTIFILM(R) FILM Beiersdorf, Inc. | MGP |
| Sep 9, 1992 | K923404 | LUEKOFLEX SURGICAL TAPE Beiersdorf, Inc. | KGX |
| Aug 10, 1992 | K921760 | TRICOPLAST Beiersdorf, Inc. | KGX |
| Aug 10, 1992 | K921759 | ACRYLASTIC Beiersdorf, Inc. | KGX |
| Apr 1, 1991 | K905688 | CUTINOVA HYDRO Beiersdorf, Inc. | KOZ |
| Mar 5, 1991 | K910274 | ARTIFLEX(TM) Beiersdorf, Inc. | LGF |
| Nov 21, 1990 | K904500 | ELASTOPLAST Beiersdorf, Inc. | KGX |
| Feb 9, 1990 | K896891 | LEUKOSILK(TM) SURGICAL TAPE Beiersdorf, Inc. | KGX |
| Nov 15, 1989 | K894367 | LEUKOSPORT(TM) ADHESIVE TAPE Beiersdorf, Inc. | KGX |
| Jun 13, 1989 | K885279 | CUTINOVA(R) PLUS ON VASCULAR STASIS ULCERS Beiersdorf, Inc. | FRO |
| Apr 22, 1988 | K881509 | LEUKOPOR(TM) SURGICAL TAPE Beiersdorf, Inc. | KGX |
| Sep 30, 1987 | K873744 | LEUKOCLIP(R) Beiersdorf, Inc. | FZQ |
| Aug 13, 1987 | K872975 | LIGHTPLAST(TM) Beiersdorf, Inc. | KGX |
| Jul 24, 1987 | K864913 | CUTINOVA(R) PLUS FOAM GELFILM Beiersdorf, Inc. | FRO |
| Apr 1, 1987 | K870504 | NORTA (TM) UROBAG Beiersdorf, Inc. | KNX |
| Nov 17, 1986 | K864160 | LEUKOPLAST(R) POROUS AND SPORT TAPE Beiersdorf, Inc. | KGX |
| Apr 8, 1986 | K861181 | NORTA TEFLON COATED LATEX BALLOON CATHETERS Beiersdorf, Inc. | KOD |
| Jul 5, 1985 | K850147 | CUTINOVA GELFILM SYNTHETIC WOUND DRESSING, STERILE Beiersdorf, Inc. | FRO |
| Feb 21, 1985 | K843876 | LEUKOFLEX SURGICAL TAPE Beiersdorf, Inc. | KGX |
| Feb 21, 1985 | K843875 | LEUKOSILK Beiersdorf, Inc. | KGX |
| Feb 21, 1985 | K843874 | LEUKOPOR SURGICAL TAPE Beiersdorf, Inc. | KGX |
| Feb 21, 1985 | K843873 | LEUKOFIX R Beiersdorf, Inc. | KGX |
| Nov 21, 1984 | K842420 | NORTA SILICONIZED LATEX BALLOON CATH. Beiersdorf, Inc. | KOD |
| Nov 8, 1984 | K842967 | AQUAPHOR R GAUZE Beiersdorf, Inc. | FRO |
| Jul 17, 1984 | K841559 | CONFORMA Beiersdorf, Inc. | GBI |
| Nov 25, 1983 | K831438 | ELASTOPLAST Beiersdorf, Inc. | FPX |
| Sep 29, 1983 | K831439 | ELASTOPLAST T.P.N. Beiersdorf, Inc. | FPX |
| Mar 9, 1983 | K823879 | COVER-ROLL STRETCH Beiersdorf, Inc. | NAB |
| Jan 14, 1983 | K823793 | ABC BRAND Beiersdorf, Inc. | |
| May 20, 1980 | K800953 | FIXOMULL STERILE Beiersdorf, Inc. | NAD |
| Mar 5, 1980 | K792725 | FIXOMULL Beiersdorf, Inc. | FPX |
| Feb 28, 1980 | K792726 | LEUKOFIX POROS Beiersdorf, Inc. | FPX |
| Jan 16, 1980 | K792667 | LEUKOCLIP POROS Beiersdorf, Inc. | FPX |
| Jan 16, 1980 | K792666 | LEUKOPOR Beiersdorf, Inc. | KGX |
| Dec 31, 1979 | K792360 | HANSAPOR STERILE Beiersdorf, Inc. | FPX |
| Dec 7, 1978 | K781931 | TAPE, ELASTOPLAST ELASTIC TEAR Beiersdorf, Inc. | FQM |
| Oct 13, 1977 | K771758 | ELASTOMULL GAUZE BANDAGE Beiersdorf, Inc. | FQM |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||