510(k) K904693 ยท KKX Drape, Surgical, Antimicrobial
CUSTOMED CARDIOVASCULAR PACK
| Applicant | Customed, Inc., Carolina Puerto Rico, US |
| Decision | Unknown, Jan 2, 1991 |
| Received | Oct 16, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K904693
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 14, 2016 | Customed, Inc Catalog Number: 9002618
OPEN HEART SURGICAL PACK
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OFA | None listed |
| Sep 3, 2015 | Customed, Inc PEDIATRIC LAP PACK 8/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
LRO | None listed |
| Sep 3, 2015 | Customed, Inc OPEN HEART TRAY 1/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
OFA | None listed |
| Sep 3, 2015 | Customed, Inc PLASTIC SURGERY PACK 5/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
LRO | None listed |
| Sep 3, 2015 | Customed, Inc OPEN HEART TRAY CUSTOMED 1/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
OFA | None listed |
| Sep 3, 2015 | Customed, Inc OPEN HEART PACK 1/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
OFA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.