Panels › Obstetrics/Gynecology › Product code OKV · Class 2
Obstetrical Kit
Regulation 884.4520
0510(k)s in 12 months (0 all time)
15recalls in 12 months (95 all time)
5recalls that name a 510(k)
Top companies in OKV
| Company | 510(k)s | Recalls |
|---|---|---|
| Customed, Inc | 0 | 52 |
| AVID Medical, Inc. | 0 | 20 |
| Medline Industries, LP | 0 | 11 |
| MEDLINE INDUSTRIES, LP - Northfield | 0 | 11 |
| Mckesson Medical-Surgical Inc. Corporate Office | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 3, 2015 | Customed, Inc O.B. PACK HOSPITAL 3/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
OKV | None listed |
| Sep 3, 2015 | Customed, Inc PERI GYN 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 |
OKV | None listed |
| Sep 3, 2015 | Customed, Inc PERY-GYN SURGICAL PACK 6/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
OKV | None listed |
| Sep 3, 2015 | Customed, Inc LABOR & DELIVERY 4/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
OKV | None listed |
| Sep 3, 2015 | Customed, Inc OBSTETRICAL SURGICAL 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 |
OKV | K902271 |
| Sep 3, 2015 | Customed, Inc O.B. 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 |
OKV | None listed |
| Sep 3, 2015 | Customed, Inc PERI GYN PACK 10/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
OKV | None listed |
| Sep 3, 2015 | Customed, Inc LABOR & DELIVERY 4/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
OKV | None listed |
| Sep 3, 2015 | Customed, Inc PREMIUM O.B. 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 |
OKV | None listed |
| Sep 3, 2015 | Customed, Inc O.B. 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 |
OKV | K902271 |
| Dec 16, 2014 | Customed, Inc Peri Gyn Pack, Catalog # 900-997
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OKV | None listed |
| Dec 16, 2014 | Customed, Inc O.B. Pack, Catalog number 900-645.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OKV | None listed |
| Dec 16, 2014 | Customed, Inc Pery Gyn Pack, Catalog number 900-635.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OKV | None listed |
| Dec 16, 2014 | Customed, Inc Pery GYN Surgical Pack, Catalog number 900-548A.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OKV | None listed |
| Dec 16, 2014 | Customed, Inc Labor & Delivery Pack, Catalog number 900-419.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OKV | None listed |
| Dec 16, 2014 | Customed, Inc OB Pack, catalog #900-254
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OKV | None listed |
| Dec 16, 2014 | Customed, Inc Cesarean Pack, Catalog number 900-1719.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OKV | None listed |
| Dec 16, 2014 | Customed, Inc Peri Gyn Pack, Catalog number 900-1716.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OKV | None listed |
| Dec 16, 2014 | Customed, Inc Labor & Delivery Pack, Catalog number 900-168.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OKV | None listed |
| Dec 16, 2014 | Customed, Inc Premium OB Pack, Catalog number 900-1297.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OKV | None listed |
| Dec 16, 2014 | Customed, Inc Peri Gyn Pack, Catalog number 900-1091.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OKV | None listed |
| Dec 16, 2014 | Customed, Inc Peri Gyn Pack, Catalog number 900-1061.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OKV | None listed |
| Dec 16, 2014 | Customed, Inc OB Pack, Catalog number 900-1030.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OKV | None listed |
| Dec 16, 2014 | Customed, Inc O.B. Pack, Catalog number 900-012.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OKV | None listed |
| Aug 29, 2014 | Customed, Inc Obstetrical Surgical pack,
code 900-2940, contains:
(1) BLANKET RECEIVING 100 COTTON
(3) TOWEL ABSORBENT 15 X 20 LIF
(10) GAUZE SPONGE 4 X 4 16PLY XRD LIF
(1) SYRINGE EAR/ULCER 2oz. LIF
(1) DRAPE ABD Terminated |
OKV | None listed |
| Aug 29, 2014 | Customed, Inc C - BIRTH PACK II {2)
CUSTOMED
CONTENT:
(1) GOWN SURGEON REINFORCED XLGE TOWEL/WRAP LIF (4) TOWEL ABSORBENT 15" X 20" LIF
(2) GOWN XLGE SMS IMPERVIOUS REINFORCED LIF (1) COVER MAYO STAND REINFORC Terminated |
OKV | None listed |
| Aug 29, 2014 | Customed, Inc 08 PAD PACK II (2,3)
CUSTOMED
CONTENTS:
(3) TOWEL ABSORBENT 15" X 20" (1) BOWL W/LID PLASTIC 80oz (1) GOWN XL SMS IMPERVIOUS REINFORCED (1) SHEET PLASTIC 44" X 65" (1) DRAPE UNDERBUTTOCK W/POUCH Terminated |
OKV | None listed |
| Aug 29, 2014 | Customed, Inc O.B. PACK -
( I) PVP SCRUB 8" STICK SPONGES
( I) UNDERBUTTOCK DRAPE WITH POUCH
(2) LEGGINS WITH 7" CUFF 30" x 42"
( I) DRAPE ABDOMINAL WITH TAPE LIF
( I) VAGINAL PACKING SPONGEXRD
( I) BOWL WITH LID Terminated |
OKV | None listed |
| Aug 29, 2014 | Customed, Inc PERl GYN PACK -
(1) TOWEL NON ABS. W/TAPE L/Free
(1) DRAPE UNDERBUTTOCK W/POUCH
(2) TOWELS ABSORBENT L/Free
(2) LEGGINGS W/7" CUFF
(1) DRAPE TOP WI ADHESIVE
(1) TABLE COVER REINF. L/Free
(10) GAUZE SP Terminated |
OKV | None listed |
| Aug 29, 2014 | Customed, Inc PERY GYN PACK-
(1) DRAPE UTILITY WITH TAPE
(1) DRAPE UNDERBUTIOCK WITH POUCH
(1) TOWELS ABSORBENT 15" x 20" UF
(2) LEGGINS W/7'' CUFF 30" X 42"
(1 ) TABLE COVER REINFORCED 50" X 90" UF
(1) DRAPE ABDO Terminated |
OKV | None listed |
| Aug 29, 2014 | Customed, Inc PREMIUM O.B. PACK - CUSTOMED-
(1) TABLE COVER REINFORCED 50" X 90" LIF
(10) GAUZE SPONGES 4" X 4" 12PLY LIF
(2) LEGGINS WITH 7" CUFF 30" x 42" LIF
(2) PAD OBSTETRICAL X-LARGE ST.
(2) SHEET DRAPE 42" X Terminated |
OKV | None listed |
| Aug 29, 2014 | Customed, Inc OB PACK -
(2) EXAM GLOVES MED.
(1 0) GAUZE SPONGES 4" X 4" 12PL Y
(2) LEGGINS W/ 7" CUFF
(2) DRAPE SHEET SMS
(1) ABDOMINAL DRAPE W/TAPE
(1) PLASTIC BOWL W/Lid 70 oz.
(1) EAR/ULCER SYRINGE 2oz. L/Free Terminated |
OKV | None listed |
| Aug 29, 2014 | Customed, Inc PERY GYN PACK- CUSTOMED-
(1) DRAPE ABDOMINAL WITH TAPE UF
(1) TOWEL ABSORBENT 15" X 20" UF
(2) LEGGINGS W/7" CUFF 30" X 42"
(1) TABLE COVER REINFORCED 44" X 78" UF
(1) DRAPE UNDERBUTTOCK WITH POUCH
Terminated |
OKV | None listed |
| Aug 29, 2014 | Customed, Inc PERl GYN PACK-
(1) DRAPE UTILITY WITH TAPE UF
(2) TOWELS ABSORBENT 15" X 20" UF
(1) TOP DRAPE WITH ADHESIVE STD SMS
(1) CATHETER NELATON ROB. 14FR.
(2) GOWN IMPERVIOUS EXTRA REINFORCED XL
(1) UNDERB Terminated |
OKV | None listed |
| Aug 29, 2014 | Customed, Inc OB PACK -
(1) BABY BLANKET PRINTED
(1) BABY BEANIES
(1) TABLE COVER REINFORCED 50" X 90" LIF
(2) LEGGINS W/7'' CUFF 30" X 42" LIF
(1) DRAPE UNDERBUTIOCK W/ POUCH 44" X 35" LIF
(3) TOWEL ABSORBENT 15" Terminated |
OKV | None listed |
| Aug 29, 2014 | Customed, Inc PERl GYN PACK
(1) TABLE COVER 44" x 90"
(2) LEGGINS W/7" CUFF 30" x 42"
(1) ABDOMINAL DRAPE WITH TAPE LIF
(2) TOWELS ABSORBENT 15" X 20"
(10) GAUZE SPONGE 4" X 4" 16PLY
(2) DRESSING NON ADH TELFA Terminated |
OKV | None listed |
| Aug 29, 2014 | Customed, Inc 0.B. PACK - -
(1) TABLE COVER 44" x 90"
(1) UNDERBUTTOCK DRAPE WITH POUCH
(2) LEGGINS WITH 7" CUFF 30" x 42"
(1) GOWN IMPERVIOUS REINFORCED LARGE SMS
(3) TOWELS ABSORBENT 15" x 20"
(1) PAD OBSTETRICA Terminated |
OKV | None listed |
| Aug 29, 2014 | Customed, Inc PERY GYN PACK-
(1) DRAPE UTILITY WITH TAPE UF
(1) UNDERBUTTOCK DRAPE WITH POUCH
(2) ABSORBENT TOWELS 15" x 20" UF
(2) LEGGINS W/7'' CUFF 30" X 42"
(1) TABLE COVER REINFORCED 50" X 90" UF
(1) ABDO Terminated |
OKV | None listed |
| Aug 29, 2014 | Customed, Inc PERY GYN PACK -
(1) TABLE COVER REINFORCED 44" X 78"
(1) DRAPE UTILITY
(2) TOWELS ABSORBENT 15" X 20"
(1) GOWN XL SMS IMPERV. REINF. AAMI LEVEL Ill
(1) DRAPE UNDERBUTIOCK W/POUCH 44" X 35"
(1) TI Terminated |
OKV | None listed |
| Aug 29, 2014 | Customed, Inc PERY GYN PACK -
(1) TABLE COVER REINFORCED 44" X 78" UF
(2) TOWEL ABSORBENT 15" X 20" LIF
(2) GOWN LARGE SMS IMPERVIOUS REINFORCED
(1) DRAPE UNDERBUTTOCK WITH POUCH
(1) UTILITY BOWL 16oz.
(10) GA Terminated |
OKV | None listed |
| Aug 29, 2014 | Customed, Inc LABOR & DELIVERY PAC -
1) NEEDLE HYPODERMIC 18G X 1% ST.
(2) DRAPE UNDERBUTTOCK WITH POUCH
(4) TOWELS ABSORBENT 15" X 20"
( 1) FEEDING TUBE 8FR, 15" LONG
( 1) BEANNIES BABY
( 1) SYRINGE 20cc WITHOU Terminated |
OKV | None listed |
| Aug 29, 2014 | Customed, Inc 0.B. PACK - HSCH-
(1) PVP SCRUB 8" STICK SPONGES
(1) UNDERBUTTOCK DRAPE WITH POUCH
(2) LEGGINS WITH 7" CUFF 30" X 42"
(1) ABDOMINAL DRAPE WITH TAPE LIF
(1) SPONGE LAP PREWASH 18" X 18" XRD LIF
(1) B Terminated |
OKV | None listed |
| Aug 29, 2014 | Customed, Inc Universal Pack- -
(1) TABLE COVER REINFORCED 50" X 90" LIF
(3) TOWEL ABSORBENT 15" X 20" LIF
(1) MAYO STAND COVER REINFORCED LIF
(1) TUBE SUCTION CONNECT. X" X 12' LIF
(1) YANKAUER SUCTION TUBE WITH Terminated |
OKV | None listed |
| Aug 29, 2014 | Customed, Inc Customed LABOR & DELIVERY PACK - Includes:
(1) TABLE COVER 44" x 90"
(2) LEGGINS WITH/7" CUFF 30" x 42"
(5) ABSORBENT TOWELS 15" x 20" LIF
(1) BABY BLANKET PRINTED LIF
(2) PAD OBSTETRICAL XLGE LIF
( Terminated |
OKV | None listed |
| Aug 29, 2014 | Customed, Inc Customed O.B. Pack
convenience pack include multiple components: set up cover, absorbent towel, ear ulcer syringe, pad, umbilical cord clamp, wash basin, baby blankets, table cover, gauze sponge, syr Terminated |
OKV | None listed |
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