Panels › Gastroenterology, Urology › Product code FHI · Class 1
Ring, Laparotomy
Regulation 876.4730
0510(k)s in 12 months (0 all time)
0recalls in 12 months (10 all time)
0recalls that name a 510(k)
Top companies in FHI
| Company | 510(k)s | Recalls |
|---|---|---|
| Customed, Inc | 0 | 10 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 29, 2014 | Customed, Inc PREMIUM LAPAROTOMY PACK - CUSTOMED-
(1) DRAPE T LAPAROT 102" X 78" X 121"
(1) GOWN XL SMS IMPERVIOUS REINFORCED
(1) COVER TABLE REINFORCED 50" X 90" LIF
(1) COVER MAYO STAND REINFORCED LIF
(4) DRAPE U Terminated |
FHI | None listed |
| Aug 29, 2014 | Customed, Inc LAPAROTOMY PACK-
(1) MAYO STAND COVER REINFORCED LIF
(10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF
(5) LAP SPONGES PRE-WASH 18" X 18" XRD LIF
(1) LITE GLOVE LIF
(1) BAG SUTURE FLORAL
(1) BLADE SURGICAL #1 Terminated |
FHI | None listed |
| Aug 29, 2014 | Customed, Inc LAPAROTOMY PACK -
CONTENTS:
( 1) GOWN XL SMS IMPERVIOUS REINFORCED LIF
( 1) MAYO STAND COVER REINFORCED LIF
(1) BAG SUTURE FLORAL LIF
(4) DRAPE UTILITY WITH TAPE LIF
(2) DRAPE SHEET 41 II X 58" SMS Terminated |
FHI | None listed |
| Aug 29, 2014 | Customed, Inc LAPAROTOMY BASIC PACK- CUSTOMED-
(1) TABLE COVER REINFORCED 44" X 78" LIF
(1) COVER MAYO STAND REINFORCED UF
(2) TOWEL ABSORBENT 15" X 20" UF
(1 0) GAUZE SPONGES XRD 4" X 4"-12PL Y
(2) DRAPE SHEET 41 Terminated |
FHI | None listed |
| Aug 29, 2014 | Customed, Inc MINOR LAPAROTOMY PACK - (1) DRAPE T LAPAROTOMY
(1) BAG SUTURE FLORAL LIF
(4) DRAPE UTILITY WITH TAPE LIF
(1) TABLE COVER REINFORCED 50" X 90" LIF
(1) MAYO STAND COVER REINFORCED LIF
(4) TOWELS ABSORB Terminated |
FHI | None listed |
| Aug 29, 2014 | Customed, Inc LAPAROTOMY PACK - (I) UTILITY BOWL 16oz
( I) ELECTRODE DUAL DEPRES./GROUNDPAD
(I) UTILITY BOWL 32oz
( I) GOWN IMP. REINFORCED XL SMS AAMI Ill
(2) NEEDLE & BLADE COUNTER I OC MAG/CLEAR
( I) DRAPE LAP Terminated |
FHI | None listed |
| Aug 29, 2014 | Customed, Inc LAPAROTOMY PACK -
(I) SURGICAL BLADE #10 S/STEEL
( I) UTILITY BOWL 32oz
(I) UTILITY BOWL 16oz
(2) NEEDLE & BLADE COUNTER IOC MAG/CLEAR
( I) DRAPE T LAPAROTOMY STD SMS
(2) TOWELS ABSORBENT 15" x 20 Terminated |
FHI | None listed |
| Aug 29, 2014 | Customed, Inc LAPAROTOMY PACK - CUSTOMED-
(1) BAG SUTURE FLORAL
(2) TOWEL ABSORBENT 15" X 20"
(1) MAYO STAND COVER REINFORCED
(1) DRAPE T LAPAROTOMY STD SMS
(2) SHEET DRAPE 42" X 57"
(1) TABLE COVER REINFORCED 50" Terminated |
FHI | None listed |
| Aug 29, 2014 | Customed, Inc Customed Laparotomy Pack , convenience pack include multiple components: drape laparot., gown, absorbent towel, scrub, stck sponges/ gauzes, table cover, drape sheet, suture bag, duraprep surgical sol Terminated |
FHI | None listed |
| Aug 29, 2014 | Customed, Inc Customed Major Laparotomy Pack , convenience pack include multiple components: Mayo stand cover, absorbent towel, bag suture, drape, suction tube, lite glove, gauze/sponges, drape, surgical blades, ut Terminated |
FHI | None listed |
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