Company ยท US
Acme United Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1996. Name variants (Inc, Corp, punctuation) are merged.
27510(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 | 5 |
| NAD | Dressing, Wound, Occlusive | 3 |
| FRO | Dressing, Wound, Drug | 2 |
| GAD | Retractor | 2 |
| GEN | Forceps, General & Plastic Surgery | 2 |
| KKX | Drape, Surgical, Antimicrobial | 2 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 |
| FPX | Strip, Adhesive, Closure, Skin | 1 |
| FPY | Sheet, Burn | 1 |
| FZQ | Clip, Removable (Skin) | 1 |
| GEC | Brush, Scrub, Operating-Room | 1 |
| JOK | Scissors, Medical, Disposable | 1 |
| KDC | Instrument, Surgical, Disposable | 1 |
| KGX | Tape And Bandage, Adhesive | 1 |
| KMK | Device, Intravascular Catheter Securement | 1 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 |
| LKB | Pad, Alcohol, Device Disinfectant | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 19, 1996 | K961323 | LYOFOAM EXTRA C ODOR ABSORBING WOUND DRESSING Acme United Corp. | KMF |
| May 31, 1996 | K961452 | LYOFOAM EXTRA 'A' STERILE ADHESIVE WOUND DRESSING Acme United Corp. | KMF |
| Nov 14, 1995 | K952565 | LYOFOAM EXTRA Acme United Corp. | KMF |
| Sep 10, 1990 | K895764 | MODIFIED LYOFOAM WOUND DRESSINGS Acme United Corp. | KMF |
| Jun 9, 1987 | K871740 | LYOSHEET SURGICAL SHEET FOR BURNS Acme United Corp. | FPY |
| Nov 21, 1986 | K864084 | LYOFOAM C ODOR-ABSORBING DRESSING Acme United Corp. | FRO |
| Jun 27, 1986 | K860085 | LYOFOAM WOUND DRESSINGS Acme United Corp. | NAD |
| May 15, 1986 | K860818 | ONE TIME ENTERAL FEEDING BAG Acme United Corp. | KNT |
| Apr 22, 1986 | K861015 | ONE TIME HYPERAL & CATHETER DRESSING CHANGE TRAYS Acme United Corp. | FOZ |
| Aug 24, 1984 | K842186 | ACU-DERM TRANSPARENT WOUND DRESSING Acme United Corp. | NAD |
| Aug 15, 1984 | K842064 | ACU-DERM TRANSPARENT IV DRESSING Acme United Corp. | KMK |
| Aug 2, 1984 | K841735 | ACU-DERM TRANSPARENT INCISE DRAPE Acme United Corp. | KKX |
| Dec 29, 1983 | K833120 | ONE TIME COMPOUND BENZOIN TINCTURE- Acme United Corp. | KGX |
| Oct 31, 1983 | K833141 | ONE TIME ACETONE/ALCOHOL;SWAB STICKS Acme United Corp. | LKB |
| Apr 12, 1983 | K830704 | ONE TIME DISPOSABLE SKIN STAPLER Acme United Corp. | FZQ |
| Oct 18, 1982 | K822865 | SURGI-SCRUB V Acme United Corp. | GEC |
| Jul 10, 1981 | K811625 | PREP-SITE PROTECTIVE DRESSING WIPE Acme United Corp. | KMF |
| May 5, 1981 | K811120 | SURGICAL STAPLE REMOVER Acme United Corp. | KDC |
| Oct 10, 1980 | K801884 | OP-SITE SKIN CLOSURE SUTURE ADHESIVE Acme United Corp. | FPX |
| Sep 4, 1979 | K791573 | JELONET PARAFFIN GAUZE DRESSINGS Acme United Corp. | FRO |
| Aug 28, 1979 | K791369 | AIRSTRIP THEATRE WARD DRESSING Acme United Corp. | NAD |
| Aug 14, 1978 | K780853 | OP-SITE ADHESIVE DRAPES Acme United Corp. | KKX |
| Apr 29, 1977 | K770481 | SHEAR, PLASTIC HANDLE UTILITY S-475-7 Acme United Corp. | JOK |
| Apr 15, 1977 | K770414 | PROBE RETRACTOR, PART #S-2L8-6 Acme United Corp. | GAD |
| Mar 23, 1977 | K770418 | RETRACTOR, SKIN HOOK Acme United Corp. | GAD |
| Nov 12, 1976 | K760507 | FORCEP, THUMB Acme United Corp. | GEN |
| Oct 21, 1976 | K760703 | SPONGE AND GAUZE FORCEP PART #S-417-9 Acme United Corp. | GEN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||