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) |
|---|---|---|---|
| Oct 15, 2026 | Medline Industries, LP Convenience Kits containing CONMED AirSeal Access Ports
KIT ROBOTICS UROLOGY PROSTATE
DYKMBNDL116G Open, Classified |
OKV | None listed |
| Oct 7, 2026 | AVID Medical, Inc. ABD HYSTERECTOMY;
Model/Item Number (Kit): NAMC438-07; Open, Classified |
OKV | None listed |
| Oct 7, 2026 | AVID Medical, Inc. GYN LAPAROSCOPY PACK;
Model/Item Number (Kit): NAMC436-12; Open, Classified |
OKV | None listed |
| Oct 7, 2026 | AVID Medical, Inc. DAVINCI LAP/GYN;
Model/Item Number (Kit): WRNM037-16; Open, Classified |
OKV | None listed |
| Aug 26, 2026 | Medline Industries, LP Medline convenience kits labeled as:
1) CMH LITHO MINOR PACK-LF, Medline Kit SKU DYNJ54362F;
2) EAST MAJOR LITHOTOMY, Medline Kit SKU DYNJ900957C;
3) GYN LAPAROTOMY, Medline Kit SKU DYNJ906804B;
Open, Classified |
OKV | None listed |
| Aug 14, 2026 | AVID Medical, Inc. Halyard LAVH PACK, Model/Catalog Number: USAR053-11 Open, Classified |
OKV | None listed |
| Jul 23, 2026 | Medline Industries, LP Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons.
KIT ROBOTICS UROLOGY PROSTATE
DYKMBNDL116G Open, Classified |
OKV | None listed |
| Jun 17, 2026 | Medline Industries, LP MEDLINE Medical Procedure Kits labeled as:
KIT URO ROBOT CYSTECTOMY, D AND C PACK, MAD D & C, VPH LITHOTOMY MINOR, TRMC- PERI GYN PACK, RICH MINOR LITHOTOMY, etc. (see recall documents for a full li Open, Classified |
OKV | None listed |
| Jun 12, 2026 | Medline Industries, LP Medline convenience kits:
DAVINCI MAIN
DYNJ908031D Open, Classified |
OKV | None listed |
| May 7, 2026 | Medline Industries, LP Medline Convenience Kits:
1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N;
2) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N;
3) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431J; Open, Classified |
OKV | None listed |
| Apr 30, 2026 | Medline Industries, LP Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows:
1. ANTERIOR CERVICAL FUSION PACK, Medline Kit Number/SKU DYNJ40566C;
2. OB PACK (OBSJD)642-LF, Medline Kit Numbe Open, Classified |
OKV | None listed |
| Apr 17, 2026 | Medline Industries, LP Medline Kits:
1) D AND C PACK, Model Number: DYNJ41254B Open, Classified |
OKV | None listed |
| Feb 17, 2026 | Medline Industries, LP Medline Convenience Kits:
1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N;
2) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431K;
3) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431O;
4) KI Open, Classified |
OKV | None listed |
| Jan 14, 2026 | Medline Industries, LP Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY PROSTATE, REF DYKMBNDL116G Open, Classified |
OKV | None listed |
| Nov 14, 2025 | Medline Industries, LP MEDLINE convenience kits labeled as: GP-LEEP PACK-LF, REF PHS396969004F Open, Classified |
OKV | None listed |
| Aug 4, 2025 | AVID Medical, Inc. LAVH PACK. Medical convenience kit. Open, Classified |
OKV | None listed |
| Aug 4, 2025 | AVID Medical, Inc. GYN ROBOTIC PACK. Medical convenience kit. Open, Classified |
OKV | None listed |
| Aug 4, 2025 | AVID Medical, Inc. GYN LAPAROSCOPY PACK. Medical convenience kit. Open, Classified |
OKV | None listed |
| Aug 4, 2025 | AVID Medical, Inc. GENERAL ROBOTIC PACK. Medical convenience kit. Open, Classified |
OKV | None listed |
| Aug 4, 2025 | AVID Medical, Inc. CT DAVINCI. Medical convenience kit. Open, Classified |
OKV | None listed |
| Apr 17, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits used for various procedures:
1) UTHET TYLER OB PACK, Model Number: DYNJ68673;
2) D AND C PACK, Model Number: DYNJ66290A;
3) D & C PACK-LF, Model Number: DYNJ24159C;
4) OB P Open, Classified |
OKV | None listed |
| Mar 25, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline procedure kits labeled as:
1) L S GYN PACK, Pack Number DYNJ65616C;
2) MAIN CYSTO, Pack Number DYNJ61371A;
3) OB PACK-LF, Pack Number DYNJ20720C;
4) PELVISCOPY PACK-LF, Pack Number DYNJ04 Open, Classified |
OKV | None listed |
| Dec 30, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline custom medical procedure kits labeled as:
1) CERVICAL PACK-LF, REF DYNJ0867145G;
2) CERVICAL SPINE PACK HUM-LF, REF DYNJ35184F;
3) ANTERIOR CERVICAL-CORPECTOMY, REF DYNJ904827. Open, Classified |
OKV | None listed |
| Dec 5, 2024 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE convenience kits labeled as:
1) TOT/ GYN LITHOTOMY CDS, REF CDS985431J;
2) TOT/ GYN LITHOTOMY CDS, REF CDS985431K;
3) TOT/ GYN LITHOTOMY CDS, REF CDS985431L;
4) GENERAL LITHOTOMY PACK, RE Open, Classified |
OKV | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard GYN PAC - Medical convenience kits
Model Number: SJGY20-02 Open, Classified |
OKV | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard C SECTION PACK - Medical convenience kits
Model Number: SJCS66-02 Open, Classified |
OKV | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard MAJOR VAGINAL GYN PACK - Medical convenience kits
Model Number: SAMM021-11 Open, Classified |
OKV | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard LAPAROTOMY GYN PACK - Medical convenience kits
Model Number: SAMM018-13 Open, Classified |
OKV | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard POST PARTUM TUBAL LIGATION - Medical convenience kits
Model Number: LANC026-19 Open, Classified |
OKV | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard VAG HYSTERECTOMY BUNDLE PK - Medical convenience kits
Model Number: LANC022-29 Open, Classified |
OKV | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard C SECTION BUNDLE - Medical convenience kits
Model Number: LANC015-34 Open, Classified |
OKV | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard GYN TRAY - Medical convenience kits
Model Number: LANC014-19 Open, Classified |
OKV | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard D & C PACK-CKC - Medical convenience kits
Model Number: BMGT003-02 Open, Classified |
OKV | None listed |
| Oct 23, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline brand medical procedure convenience kits, labeled as:
a) OB PACK-LF, REF DYNJ0912449M;
b) OB PACK, REF DYNJ17309G;
c) OB PK, REF DYNJ34268D;
d) OB DELIVERY PACK, REF DYNJ34274B;
e) OB DE Open, Classified |
OKV | None listed |
| Oct 23, 2024 | MEDLINE INDUSTRIES, LP - Northfield Centurion OB TRAY, REF MNS13965A; medical procedure convenience kit Open, Classified |
OKV | None listed |
| Sep 6, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits labeled as:
1) LABOR & DELIVERY CDS, Pack Number CDS830039AD;
2) FETAL SURGERY CDS-LF, Pack Number CDS840214P ;
3) OB PROCEDURE-LF , Pack Number CDS981335C ;
4) ROBOTIC P Open, Classified |
OKV | None listed |
| Feb 25, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline Kits, trays, and packs labeled as follows:
a) D&C CDS, REF CDS983911J;
b) D&C PACK, REF DYNJ67214F;
c) D&C PACK, REF DYNJ67214G Open, Classified |
OKV | None listed |
| Aug 3, 2023 | MEDLINE INDUSTRIES, LP - Northfield Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following:
a. EGG RETRIEVAL PACK, Model Number: DYNJ66291B;
b. FETAL SURGERY CDS-LF, Model Numbe Open, Classified |
OKV | None listed |
| Jul 20, 2023 | MEDLINE INDUSTRIES, LP - Northfield Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:
a) FETAL SURGERY CDS-LF, Model Number CDS840214P;
b) ABLATION PACK, Model Number DYNJ82725 Open, Classified |
OKV | None listed |
| Feb 6, 2023 | MEDLINE INDUSTRIES, LP - Northfield Sterile Procedural Trays, labeled as the following:
a. CELEBRATION ROBOTIC CDS
b. DAVINCI CDS UCC-LF
c. ROBOTICS PACK-LF
d. ROBOTICS PACK-LF
e. ROBOTIC PACK
f. PELVISCOPY PACK-LF
g. CUSTOM LITHOTOM Open, Classified |
OKV | None listed |
| Aug 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office MORRISON MEDICAL Morrison Medical OB KIT, HARD PK SEALED W/CARDBOARD BX MORMED
Catalog #0967NL Open, Classified |
OKV | None listed |
| Feb 18, 2020 | Avid Medical, Inc. Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers. Terminated |
OKV | None listed |
| Apr 19, 2017 | Avid Medical, Inc. Vacutainer Tubes
Vacutainer tubes are intended for clinical laboratory hematology studies including but not limited to lead level testing, FEP level testing, and CBC testing. Terminated |
OKV | None listed |
| Apr 14, 2016 | Customed, Inc Catalog Number: 900997
PERI-GYN SURGICAL PACK
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 |
| Apr 14, 2016 | Customed, Inc Catalog Number: 900548A
PERY-GYN SURGICAL PACK
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 |
| Apr 14, 2016 | Customed, Inc Catalog Number: 900419
LABOR & DELIVERY SURGICAL PACK
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 |
| Apr 14, 2016 | Customed, Inc Catalog Number: 9002940
OBSTETRICAL SURGICAL PACK
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OKV | K902271 |
| Apr 14, 2016 | Customed, Inc Catalog Number: 9001297
PREMIUM OBSTETRICAL SURGICAL PACK
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, et Terminated |
OKV | K902032 |
| Apr 14, 2016 | Customed, Inc Catalog Number: 900012 OB SURGICAL PACK
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 PERI GYN PACK 5/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate Terminated |
OKV | None listed |
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