Company ยท US
Smith & Nephew United, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1989 to 1996. Name variants (Inc, Corp, punctuation) are merged.
34510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KMF | Bandage, Liquid | 7 |
| KGX | Tape And Bandage, Adhesive | 6 |
| KOZ | Beads, Hydrophilic, For Wound Exudate Absorption | 3 |
| NAD | Dressing, Wound, Occlusive | 3 |
| NAE | Dressing, Wound, Hydrogel Without Drug And/Or Biologic | 3 |
| EFQ | Gauze/Sponge, Internal | 2 |
| KOX | Solvent, Adhesive Tape | 2 |
| NAB | Gauze / Sponge,Nonresorbable For External Use | 2 |
| FLK | Thermometer, Clinical Mercury | 1 |
| FRO | Dressing, Wound, Drug | 1 |
| GYB | Media, Electroconductive | 1 |
| MDA | Elastomer, Silicone, For Scar Management | 1 |
| MGP | Dressing, Wound And Burn, Occlusive | 1 |
| MGQ | Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 25, 1996 | K963096 | ALLEVYN HYDRO POLY DRESSING ND ALL TRAC DRESSING Smith & Nephew United, Inc. | KMF |
| Jul 16, 1996 | K961775 | PROFORE FOUR-LAYER BANDAGE SYSTEM KIT Smith & Nephew United, Inc. | EFQ |
| Feb 9, 1995 | K945330 | ALLEVYN ADHESIVE Smith & Nephew United, Inc. | KMF |
| Aug 19, 1994 | K943619 | CAVI-CARE CONFORMING FOAM DRESSING Smith & Nephew United, Inc. | KMF |
| Jun 29, 1994 | K942748 | INTRASITE Smith & Nephew United, Inc. | NAE |
| Feb 15, 1994 | K935705 | ALLEVYN ISLAND WOUND DRESSING Smith & Nephew United, Inc. | NAE |
| Feb 3, 1994 | K935803 | CICA-CARE SILICONE GEL SHEET Smith & Nephew United, Inc. | MDA |
| Oct 1, 1993 | K932263 | SOLOSITE DERMAL WOUND GEL Smith & Nephew United, Inc. | MGQ |
| Jul 13, 1993 | K926508 | INTRASITE GEL Smith & Nephew United, Inc. | NAE |
| Sep 15, 1992 | K922897 | STRAPPAL Smith & Nephew United, Inc. | KGX |
| Feb 3, 1992 | K914147 | ALLEVLYN WOUND DRESSING, MODIFICATION Smith & Nephew United, Inc. | KMF |
| Jan 9, 1992 | K915150 | REMOVE ADHESIVE REMOVER Smith & Nephew United, Inc. | KOX |
| Jul 17, 1991 | K911682 | AIRSTRIP FIRST AID & POST-OP DRESSING Smith & Nephew United, Inc. | KGX |
| Jun 17, 1991 | K911660 | INTRASITE HYDROCOLLOID WOUND DRESSING Smith & Nephew United, Inc. | MGP |
| Nov 26, 1990 | K904411 | INTRASITE GEL (LABELING REVISION) Smith & Nephew United, Inc. | KMF |
| Oct 23, 1990 | K904412 | ALLEVYN DRESSING CLAIMS CHANGE Smith & Nephew United, Inc. | KOZ |
| Jun 28, 1990 | K901876 | INTRASITE CAVITY WOUND DRESSING (LABEL REVISION) Smith & Nephew United, Inc. | KOZ |
| Jun 22, 1990 | K901879 | INTRASITE HYDROCOLLOID DRESSING (REVISED LABELING) Smith & Nephew United, Inc. | KGX |
| Jun 22, 1990 | K901878 | INTRASITE GEL (LABELING REVISION) Smith & Nephew United, Inc. | KMF |
| Jun 22, 1990 | K901877 | ALLEVYN DRESSING (LABELING REVISED) Smith & Nephew United, Inc. | KMF |
| Jun 12, 1990 | K901378 | TENSOPLUS LITE Smith & Nephew United, Inc. | NAD |
| Dec 14, 1989 | K895408 | OPSITE*WOUND (FLEXIGRID APPLICATION SYSTEM) Smith & Nephew United, Inc. | KGX |
| Nov 21, 1989 | K893604 | TENS PREP Smith & Nephew United, Inc. | GYB |
| Nov 7, 1989 | K895354 | INTRASITE CAVITY WOUND DRESSING Smith & Nephew United, Inc. | KOZ |
| Sep 28, 1989 | K895353 | OPSITE I.V. 3000 Smith & Nephew United, Inc. | KGX |
| Aug 31, 1989 | K894254 | HYPAFIX DRESSING RETENTION SHEET Smith & Nephew United, Inc. | NAD |
| Aug 9, 1989 | K891870 | INTRASITE* GEL (3) YEAR SHELF LIFE Smith & Nephew United, Inc. | FRO |
| Aug 8, 1989 | K893602 | GLASS MERCURY FILLED THERMOMETERS Smith & Nephew United, Inc. | FLK |
| Aug 3, 1989 | K893900 | PRIMAPORE I.V. Smith & Nephew United, Inc. | KGX |
| Jul 14, 1989 | K893603 | REMOVE ADHESIVE REMOVER Smith & Nephew United, Inc. | KOX |
| Apr 17, 1989 | K891460 | NON-ABSORB GAUZE SURG SPONGE & WOUND DRESS/EXT USE Smith & Nephew United, Inc. | EFQ |
| Apr 17, 1989 | K891101 | NON-ABSORBABLE GAUZE, SURGICAL SPONGE & DRESSING Smith & Nephew United, Inc. | NAB |
| Apr 7, 1989 | K890672 | ABSORBENT GAUZE ROLL Smith & Nephew United, Inc. | NAB |
| Mar 8, 1989 | K890748 | ALLEVYN TRACHEOSTOMY DRESSING Smith & Nephew United, Inc. | NAD |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||