Smith & Nephew United, Inc.
Largo, FL, US
Smith & Nephew United, Inc. appears in FDA device records in Largo, FL. FDA records list 34 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 34
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 34 510(k) clearances for Smith & Nephew United, Inc. between 1989 and 1996. The busiest year on record is 1989, with 13. The most recent is 1996, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1989 | 13 |
| 1990 | 7 |
| 1991 | 2 |
| 1992 | 3 |
| 1993 | 2 |
| 1994 | 4 |
| 1995 | 1 |
| 1996 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K963096 | ALLEVYN HYDRO POLY DRESSING ND ALL TRAC DRESSING | KMF | Substantially Equivalent | |
| K961775 | PROFORE FOUR-LAYER BANDAGE SYSTEM KIT | EFQ | Substantially Equivalent | |
| K945330 | ALLEVYN ADHESIVE | KMF | Substantially Equivalent for Some Indications | |
| K943619 | CAVI-CARE CONFORMING FOAM DRESSING | KMF | Substantially Equivalent for Some Indications | |
| K942748 | INTRASITE | NAE | Substantially Equivalent for Some Indications | |
| K935705 | ALLEVYN ISLAND WOUND DRESSING | NAE | Substantially Equivalent | |
| K935803 | CICA-CARE SILICONE GEL SHEET | MDA | Substantially Equivalent | |
| K932263 | SOLOSITE DERMAL WOUND GEL | MGQ | Substantially Equivalent | |
| K926508 | INTRASITE GEL | NAE | Substantially Equivalent | |
| K922897 | STRAPPAL | KGX | Substantially Equivalent | |
| K914147 | ALLEVLYN WOUND DRESSING, MODIFICATION | KMF | Substantially Equivalent | |
| K915150 | REMOVE ADHESIVE REMOVER | KOX | Substantially Equivalent | |
| K911682 | AIRSTRIP FIRST AID & POST-OP DRESSING | KGX | Substantially Equivalent | |
| K911660 | INTRASITE HYDROCOLLOID WOUND DRESSING | MGP | Substantially Equivalent | |
| K904411 | INTRASITE GEL (LABELING REVISION) | KMF | Substantially Equivalent for Some Indications | |
| K904412 | ALLEVYN DRESSING CLAIMS CHANGE | KOZ | Substantially Equivalent for Some Indications | |
| K901876 | INTRASITE CAVITY WOUND DRESSING (LABEL REVISION) | KOZ | Substantially Equivalent for Some Indications | |
| K901879 | INTRASITE HYDROCOLLOID DRESSING (REVISED LABELING) | KGX | Substantially Equivalent | |
| K901878 | INTRASITE GEL (LABELING REVISION) | KMF | Substantially Equivalent | |
| K901877 | ALLEVYN DRESSING (LABELING REVISED) | KMF | Substantially Equivalent | |
| K901378 | TENSOPLUS LITE | NAD | Substantially Equivalent | |
| K895408 | OPSITE*WOUND (FLEXIGRID APPLICATION SYSTEM) | KGX | Substantially Equivalent | |
| K893604 | TENS PREP | GYB | Substantially Equivalent | |
| K895354 | INTRASITE CAVITY WOUND DRESSING | KOZ | Substantially Equivalent for Some Indications | |
| K895353 | OPSITE I.V. 3000 | KGX | Substantially Equivalent | |
| K894254 | HYPAFIX DRESSING RETENTION SHEET | NAD | Substantially Equivalent | |
| K891870 | INTRASITE* GEL (3) YEAR SHELF LIFE | FRO | Substantially Equivalent | |
| K893602 | GLASS MERCURY FILLED THERMOMETERS | FLK | Substantially Equivalent | |
| K893900 | PRIMAPORE I.V. | KGX | Substantially Equivalent for Some Indications | |
| K893603 | REMOVE ADHESIVE REMOVER | KOX | Substantially Equivalent | |
| K891460 | NON-ABSORB GAUZE SURG SPONGE & WOUND DRESS/EXT USE | EFQ | Substantially Equivalent for Some Indications | |
| K891101 | NON-ABSORBABLE GAUZE, SURGICAL SPONGE & DRESSING | NAB | Substantially Equivalent for Some Indications | |
| K890672 | ABSORBENT GAUZE ROLL | NAB | Substantially Equivalent | |
| K890748 | ALLEVYN TRACHEOSTOMY DRESSING | NAD | Substantially Equivalent for Some Indications |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KMFBandage, Liquid
- KOZBeads, Hydrophilic, For Wound Exudate Absorption
- MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
- MGPDressing, Wound And Burn, Occlusive
- FRODressing, Wound, Drug
- NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic
- NADDressing, Wound, Occlusive
- MDAElastomer, Silicone, For Scar Management
- NABGauze / Sponge,Nonresorbable For External Use
- EFQGauze/Sponge, Internal
- GYBMedia, Electroconductive
- KOXSolvent, Adhesive Tape
- KGXTape And Bandage, Adhesive
- FLKThermometer, Clinical Mercury
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain