Panels › Obstetrics/Gynecology › Product code OHM · Class 2
Cesarean Section Tray
Regulation 884.1720
0510(k)s in 12 months (0 all time)
14recalls in 12 months (75 all time)
3recalls that name a 510(k)
Top companies in OHM
| Company | 510(k)s | Recalls |
|---|---|---|
| Customed, Inc | 0 | 33 |
| Medline Industries Inc | 0 | 17 |
| MEDLINE INDUSTRIES, LP - Northfield | 0 | 12 |
| American Contract Systems | 0 | 6 |
| Cardinal Health 200, LLC | 0 | 3 |
| ROi CPS LLC | 0 | 3 |
| DeRoyal Industries Inc | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 3, 2015 | Customed, Inc PREMIUM CESAREAN PACK CUSTOMED 5/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
OHM | None listed |
| Dec 16, 2014 | Customed, Inc C-Section Pack, Catalog # 900-998
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OHM | None listed |
| Dec 16, 2014 | Customed, Inc C-Section Surgical Pack, Catalog # 900-921A
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OHM | None listed |
| Dec 16, 2014 | Customed, Inc Cesarean Pack, Catalog # 900-851
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OHM | None listed |
| Dec 16, 2014 | Customed, Inc Cesarean Pack, Catalog # 900-660
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OHM | None listed |
| Dec 16, 2014 | Customed, Inc Cesarean Pack, Catalog number 900-410.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OHM | None listed |
| Dec 16, 2014 | Customed, Inc Cesarean Pack, Catalog number 900-403.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OHM | None listed |
| Dec 16, 2014 | Customed, Inc Cesarean Pack, Catalog number 900-1689.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OHM | None listed |
| Dec 16, 2014 | Customed, Inc Premium Cesarean Pack, Catalog number 900-1294
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OHM | None listed |
| Aug 29, 2014 | Customed, Inc CESAREAN PACK -
(1) BABY BLANKET IMP. POLY ABS.
(4) ABSORBENT TOWELS 15" x 20" LIF
(2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR LIF
(2) LITE GLOVES LIF
(1) BOWL PLASTIC WITH LID 80 oz.
(1) C-SECTION D Terminated |
OHM | None listed |
| Aug 29, 2014 | Customed, Inc CESAREAN PACK -
(1) MAYO STAND COVER REINFORCED LIF
(5) TOWELS ABSORBENT LIF
(1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED L/F
(3) DRAPE SHEET 41" X 58" SMS LIF
(1) BABY BLANKET PRINTED LIF
(1) BOWL PLA Terminated |
OHM | None listed |
| Aug 29, 2014 | Customed, Inc CESAREAN PACK -
(1) BABY BLANKET IMP. 30" X 30" POLY ABS.
(1) NEEDLE & BLADE COUNTER 60c FOAM/STRIP MAG/STRIP LIF
(1) DRESSING ISLAND 4" x 10"
(1) CESAREAN DRAPE 71" x 125" LIF
(2) GOWN SURG REINFORC Terminated |
OHM | None listed |
| Aug 29, 2014 | Customed, Inc PREMIUM CESAREAN PACK- CUSTOMED-
(1)BABY BLANKET IMP. 30" X 30" POLY ABSORBENT
(3) TOWELS ABSORBENT 15" X 20" LIF
(1) BOWL PLASTIC 80oz WITH LID
(10) LAP SPONGE PREWASH XRD LIF
(2) PAD OBSTETRICAL X- Terminated |
OHM | None listed |
| Aug 29, 2014 | Customed, Inc C-SECTION PACK -
(1) TABLE COVER REINFORCED 50" X 90" L/F
(3) TOWELS ABSORBENT 15" X 20" L/F
(1) BABY BLANKET
(1 0) GAUZE SPONGE 4" X 4" 16PLY XRD LIF
(1) GOWN SURG. SMS POLY-REINF BREATHABLE IMPERV Terminated |
OHM | None listed |
| Aug 29, 2014 | Customed, Inc C-SECTION SURGICAL PACK-
(1) COVER TABLE REINFORCED 50" X 90"
(2) TOWELS ABSORBENT 15" X 20"
(1) MAYO STAND COVER REINFORCED
(1) BABY BLANKET PRINTED
(1 0) LAP SPONGES PREWASH 18" X 18" XRD
(1) BOWL Terminated |
OHM | None listed |
| Aug 29, 2014 | Customed, Inc CESAREAN PACK-
(1) COVER TABLE REINFORCED 50" X 90"
(2) TOWELS ABSORBENT 15" X 20"
(1) BABY BLANKET PRINTED
(1) BOWL PLASTIC WITH LID 80oz.
(2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR
(1) CORD UMBILICAL Terminated |
OHM | None listed |
| Aug 29, 2014 | Customed, Inc CESAREAN PACK-
(1) BEANNIES BABY LIF
(1) TABLE COVER REINFORCED 50" X 90" LIF
(1) COVER MAYO STAND REINFORCED LIF
(3) SHEET DRAPE 41 " X 58" SMS LIF
(5) TOWEL ABSORBENT 15" X 20" LIF
(15) SPONGE LAP Terminated |
OHM | None listed |
| Aug 29, 2014 | Customed, Inc CESAREAN PACK- -
(3) ABSORBENT TOWELS 15" x 20" LIF
(1) PLASTIC BOWL WITH LID 80oz.
(1 0) LAP SPONGES PRE-WASH 18" x 18" XRD
(2) PAD OBSTETRICAL X-LARGE ST.
(1) MAYO STAND COVER REINFORCED LIF
(1) D Terminated |
OHM | None listed |
| Aug 29, 2014 | Customed, Inc CESAREAN PACK - -
(1) MAYO STAND COVER REINFORCED LIF
(20) LAP SPONGES PRE-WASH XRD LIF
(1) UMBILICAL CORD CLAMP LIF
(1) COVER TABLE REINFORCED 50" X 90" LIF
(1) SURGICAL DURAPREP SOLUTION 26ML LIF
Terminated |
OHM | None listed |
| Aug 29, 2014 | Customed, Inc CESAREAN PACK - -
(7) TOWELS ABSORBENT 15" X 20"
(2) SCALPEL WEIGHTED SAFETY #1 0
(1) BLANKET BABY 30" X 30" POLY ABS IMP
(1) BOWL UTILITY QUART 32oz.
(1) TUBE FEEDING 8Fr. 15" LONG
(2) COUNTER NEE Terminated |
OHM | None listed |
| Oct 10, 2008 | Medline Industries Inc Medline Latex Free Mom/Baby Admit Kit - LF; a single patient prescription procedure pack and disposables, including a Gerber Nuk Pacifier; Made in USA by Medline Industries, Inc., Mundelein, IL 60060 Terminated |
OHM | None listed |
| Oct 10, 2008 | Medline Industries Inc Medline Latex Free Labor & Delivery CDS-LF; a single patient prescription procedure pack and disposables, including a Gerber Nuk Pacifier; Made in USA by Medline Industries, Inc., Mundelein, IL 60060 Terminated |
OHM | None listed |
| Oct 10, 2008 | Medline Industries Inc Medline Latex Free Labor Kit & Postpartum CDS-LF; a single patient prescription procedure pack and disposables, including a Gerber Nuk Pacifier; Made in USA by Medline Industries, Inc., Mundelein, IL Terminated |
OHM | None listed |
| Oct 10, 2008 | Medline Industries Inc Medline Latex Free Vaginal Delivery CDS-LF; a single patient prescription procedure pack and disposables, including a Gerber Nuk Pacifier; Made in USA by Medline Industries, Inc., Mundelein, IL 60060 Terminated |
OHM | None listed |
| Oct 10, 2008 | Medline Industries Inc Medline Latex Free C-Section CDS-LF and C-Section Supplemental CDS-LF; a single patient prescription procedure pack and disposables, including a Gerber Nuk Pacifier; Made in USA by Medline Industries, Terminated |
OHM | None listed |
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