510(k) K902031 ยท KKX Drape, Surgical, Antimicrobial
CUSTOMED LAP PACK IV
| Applicant | Customed, Inc., Fajardo PR, US |
| Decision | Substantially Equivalent, Jul 12, 1990 |
| Received | May 4, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K902031
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 14, 2016 | Customed, Inc Catalog Number: 900036 LAPAROTOMY SURGICAL PACK
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 |
| Apr 14, 2016 | Customed, Inc Catalog Number: 900052 MINOR PROCEDURE SURGICAL PACK
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 |
| Apr 14, 2016 | Customed, Inc Catalog Number: 900176
LAPAROTOMY SURGICAL PACK
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 |
| Apr 14, 2016 | Customed, Inc Catalog Number: 9002516
LAPAROTOMY SURGICAL PACK
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 MAJOR LAPAROTOMY PK 4/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 MINOR PROCEDURE PACK 40/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 LAPAROTOMY PACK CUSTOMED 7/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 MAJOR LAP PACK 4/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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.