Company ยท US
Medikmark, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1992 to 1995. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 2, 1995 | K953474 | IV START KIT Medikmark, Inc. | FPA |
| Oct 7, 1994 | K923960 | UPPER EXTERMITY DRAPE KIT Medikmark, Inc. | KKX |
| Jun 15, 1994 | K921733 | TRACHEOSTOMY CARE TRAY Medikmark, Inc. | JOH |
| Jun 15, 1994 | K921732 | MINOR LAP SET Medikmark, Inc. | KOH |
| Jun 15, 1994 | K921730 | C-SECTION PACK Medikmark, Inc. | KOH |
| Apr 23, 1992 | K920341 | LACERATION TRAYS Medikmark, Inc. | KKX |
| Apr 23, 1992 | K920340 | SUTURE REMOVAL KIT Medikmark, Inc. | KKX |
| Apr 23, 1992 | K920339 | DRESSING CHANGE TRAY Medikmark, Inc. | FRG |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 22, 2004 | Medikmark, Incorporated Staple Removal Set/Kit; a sterile Rx convenience kit containing a staple remover and a gauze sponge. Theses kits were marketed under the following labels, 50 kits per case:
a) Medikmark inc. Staple R Terminated |
KKX | K920340 |
| Jul 22, 2004 | Medikmark, Incorporated MediChoice Skin Staple Remover, reorder no. SSR 1001; a sterile Rx convenience kit containing a skin staple remover, a PVP prep pad and a 3 x 3 gauze sponge; 50 kits per case; Made for Owens & Minor Terminated |
KKX | K920340 |
| Jul 22, 2004 | Medikmark, Incorporated Staple Removal Tray/Set/Kit; a sterile Rx convenience kit containing a staple remover instrument, an alcohol prep pad, a PVP prep pad and a gauze sponge. Theses kits were marketed under the following Terminated |
KKX | K920340 |