Panels › Obstetrics/Gynecology › Product code MLS · Class 2
Labor And Delivery Kit
Regulation 884.4530
0510(k)s in 12 months (6 all time)
10recalls in 12 months (46 all time)
0recalls that name a 510(k)
Top companies in MLS
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 31, 2026 | Medline Industries, LP Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators
LABOR CDS
CDS981762B
VAG DELIVERY ADMISSION BAG
DYKA1054F Open, Classified |
MLS | None listed |
| Aug 31, 2026 | Medline Industries, LP Medline Convenience Kits:
1) LABOR CDS, Model Number: CDS981762B;
2) VAG DELIVERY ADMISSION BAG, Model Number: DYKA1054F Open, Classified |
MLS | None listed |
| Jun 29, 2026 | Medline Industries, LP Medline Convenience Kits:
1) L&D CONTINUOUS EPIDURAL TRAY, Model Number: PAIN1699A Open, Classified |
MLS | None listed |
| Jun 17, 2026 | Medline Industries, LP MEDLINE Medical Procedure Kits labeled as:
1) BR L&D PACK, Medline Kit Number/SKU DYNJ47625B;
2) GYN VAGINAL, Medline Kit Number/SKU DYNJ912219;
3) KIT MAJ VAG SET UP, Medline Kit Number/SKU DYNJ9 Open, Classified |
MLS | None listed |
| Jun 12, 2026 | Medline Industries, LP Medline convenience kit:
(82)LABOR & DELIVERY C-SECTION
DYNJ907895F Open, Classified |
MLS | None listed |
| May 7, 2026 | Medline Industries, LP Medline Convenience Kits:
1) OB KIT, Model Number: DYKM2326;
2) KIT LABOR DELIVERY TUBAL LIGAT, Model Number: DYKMBNDL165;
3) KIT LABOR & DELIVERY D&C/D&E, Model Number: DYKMBNDL31;
4) KIT LABOR & Open, Classified |
MLS | None listed |
| Apr 17, 2026 | Medline Industries, LP Medline Kits:
1) LABOR PACK-22025208-LF, Model Number: DYNJ44813D Open, Classified |
MLS | None listed |
| Apr 7, 2026 | Medline Industries, LP Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows:
1. DELIVERY PACK, Medline SKU # DYNJ42892F;
2. DELIVE Open, Classified |
MLS | None listed |
| Feb 17, 2026 | Medline Industries, LP Medline Convenience Kits:
1) OB KIT, Model Number: DYKM2326;
2) KIT LABOR DELIVERY TUBAL LIGAT, Model Number: DYKMBNDL165;
3) KIT LABOR & DELIVERY D&C/D&E, Model Number: DYKMBNDL31;
4) KIT LABOR & Open, Classified |
MLS | None listed |
| Nov 14, 2025 | Medline Industries, LP MEDLINE convenience kits labeled as:
1) MAJOR VAGINAL HARPER PACK-LF, REF DYNJ0161768G;
2) ACH MAJOR VAGINAL PACK, REF DYNJ67757B. Open, Classified |
MLS | None listed |
| Oct 16, 2025 | American Contract Systems Inc. Medical convenience kits
Item number/ Product description
AHLD15X LABOR DELIVERY PACK - 213387
AKDV96B VAGINAL DELIVERY
AKDV96B VAGINAL DELIVERY
EVBH28D BIRTHING ROOM PACK
UPVD01K VAGINAL DELIVERY P Open, Classified |
MLS | None listed |
| Aug 28, 2025 | American Contract Systems Inc AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as:
1) BORN ON ARRIVAL KIT, Model/Item Number LLBN11C;
2) LABOR & DELIVERY PACK, Model/Item Number LLLD19I. Open, Classified |
MLS | None listed |
| Apr 17, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits used for various procedures:
1) LABOR AND DELIVERY PACK-LF, Model Number: DYNJ26971L;
2) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ0378319P;
3) VUWC OB PACK, Model Number: Open, Classified |
MLS | None listed |
| Mar 25, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline procedure kits labeled as:
1) DELIVERY PACK, Pack Number DYNJ0923016;
2) DELIVERY PACK-LF, Pack Number DYNJ0968863M;
3) L & D PACK-LF, Pack Number DYNJ0373290N;
4) L&D PACK, Pack Number D Open, Classified |
MLS | None listed |
| Mar 14, 2025 | American Contract Systems Inc DELIVERY PACK
, Model No SGDV22D-01
SGDV22E Open, Classified |
MLS | None listed |
| Mar 14, 2025 | American Contract Systems Inc LABOR & DELIVERY PPS
, Model No LLLD64O
LLLD64O-01
LLLD64O-02 Open, Classified |
MLS | None listed |
| Mar 14, 2025 | American Contract Systems Inc BORN ON ARRIVAL KIT
, Model No LLBN11B Open, Classified |
MLS | None listed |
| Mar 14, 2025 | American Contract Systems Inc LABOR & DELIVERY PACK, Model Nos LLLD19H Open, Classified |
MLS | None listed |
| Feb 4, 2025 | ROi CPS LLC regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery. Open, Classified |
MLS | None listed |
| Dec 30, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline custom medical procedure kits labeled as:
DEEP BRAIN STIMULATION PACK-LF Open, Classified |
MLS | None listed |
| Dec 5, 2024 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE convenience kits labeled as:
1) VAGINAL, REF CDS984955M;
2) DAY SURG LARGE VAG CDS, REF CDS984995M;
3) MAJOR VAGINAL PACK-LF, REF DYNJ0826768P;
4) VAGINAL PACK, REF DYNJ59081C;
5)VAGINOP Open, Classified |
MLS | None listed |
| Nov 22, 2024 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE procedure kits labeled as follows:
1) L&D CONTINUOUS EPIDURAL TRAY, REF PAIN1699;
2) L&D CONTINUOUS EPIDURAL TRAY, REF PAIN1699A Open, Classified |
MLS | None listed |
| Oct 23, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline brand medical procedure convenience kits, labeled as: 1) L&D/OB PACK-LF, REF DYNJ0213264O;
2) VAG DELIVERY HLTH ALLIA PK-LF, REF DYNJ0375486K;
3) VAG DELIVERY HLTH ALLIA PK-LF, REF DYNJ0375 Open, Classified |
MLS | None listed |
| Sep 24, 2024 | American Contract Systems, Inc. Vaginal Delivery, ASDV25B; Medical convenience kit Open, Classified |
MLS | None listed |
| Sep 24, 2024 | American Contract Systems, Inc. Endovascular AAA Pack, ESED52B; Medical convenience kit Open, Classified |
MLS | None listed |
| Sep 6, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits labeled as:
1) PACK VAGINAL DELIVERY , Pack Number AM185B ;
2) LABOR & DELIVERY CDS, Pack Number CDS830039AF;
3) LABOR & DELIVERY CDS, Pack Number CDS830039AI;
4) LABOR & Open, Classified |
MLS | None listed |
| Aug 28, 2024 | MEDLINE INDUSTRIES, LP - Northfield Centurion procedure packs, containing Caina syringes, labeled as:
1) ARTHROGRAM TRAY, Pack Number MNS11965A;
2) CIRCUMCISION TRAY, Pack Number CIT6720;
3) CIRCUMCISION TRAY, Pack Number CIT6720A Open, Classified |
MLS | None listed |
| Aug 28, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline procedural kits labeled as:
1) INFANT DELIVERY KIT , Pack Number DYKM1426;
2) SR OB DELIVERY , Pack Number DYNJ908583;
3) SR OB DELIVERY , Pack Number DYNJ908583A;
4) VAG DELIVERY, Pack N Open, Classified |
MLS | None listed |
| Aug 28, 2024 | MEDLINE INDUSTRIES, LP - Northfield Centurion procedure kits, labeled as:
1) ARTHROGRAM TRAY, Pack Number DYNDH1349;
2) ARTHROGRAM TRAY-LF, Pack Number SPEC0400;
3) ARTHROGRAM/LP/MYELOGRAM TRAY, Pack Number PT220;
4) BIOPSY KIT, Pa Open, Classified |
MLS | None listed |
| Jun 28, 2024 | MEDLINE INDUSTRIES, LP - Northfield Nonsterile convenience kits:
a. Medline Delivery, Pack #DYNJ901130I, containing a Pure Pouch with component Reorder #DYND04000, O.R. Scissors, S/B, 5.5 Sterile.
b. Medline C-Section, Pack DYNJ9029 Open, Classified |
MLS | None listed |
| Jun 28, 2024 | MEDLINE INDUSTRIES, LP - Northfield Sterile convenience kit:
Medline Birthing Room Pack, Pack #DYNJ38429D, containing a Pure Pouch component Sterile Sharp/Blunt Scissors 5.5", Reorder #65945 and containing a Pure Pouch component Steril Open, Classified |
MLS | None listed |
| Feb 25, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline Kits, trays, and packs labeled as follows:
a) L&B CDS-LF, REF CDS980273D;
b) LABOR AND DELIVERY, REF DYNJ907794;
c) LACERATION TRAY, REF DYNDL1864A;
d) OBSTETRICAL, REF DYNJ908877;
e) UM Open, Classified |
MLS | None listed |
| Jan 26, 2024 | American Contract Systems, Inc. Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as:
a) LABOR & DELIVERY PACK, kit number HILD52F;
b) LABOR & DELIVERY PACK, kit number HILD52G Open, Classified |
MLS | 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. FETAL INTERVENTION, Model Number: DYNJ66041A, DYNJ66041B;
b. FETAL INTERVENTION PA Open, Classified |
MLS | None listed |
| Jul 20, 2023 | MEDLINE INDUSTRIES, LP - Northfield Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:
a) VAD/PICC IV KIT, Model Number DYNDV2200;
b) ULTRASOUND PIV KIT, Model Number DYNDV2397;
c) VAD ACCESS, Mode Open, Classified |
MLS | None listed |
| Apr 25, 2023 | ROi CPS LLC Sterile surgical convenience kit: regard Item Number: 800718003, GY00923C - WPH Major Vaginal Pack. Open, Classified |
MLS | None listed |
| Feb 6, 2023 | MEDLINE INDUSTRIES, LP - Northfield Sterile Procedural Trays, labeled as the following:
a. GYN LAPAROTOMY HARPER PACK-LF
b. OB GYN LAP PACK-LF
c. VAGINAL HYSTERECTOMY PACK
d. DELTA PACK
e. MAJOR VAGINAL-LF
f. GYN LAPAROSCOPY II Open, Classified |
MLS | None listed |
| Jun 16, 2022 | American Contract Systems, Inc. Various ob/gyn packs Open, Classified |
MLS | None listed |
| Apr 26, 2022 | ROi CPS LLC Convenience kits containing regard IV Start Kits:
(1) regard Clinical Packaging Solutions, Item Number: 830015013, LD00200M - Vag Delivery Mother; and
(2) regard Clinical Packaging Solutions, Item Terminated |
MLS | None listed |
| Dec 22, 2021 | ROi CPS LLC regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles. Terminated |
MLS | None listed |
| Aug 10, 2021 | ROi CPS LLC REGARD Newborn Tray Terminated |
MLS | None listed |
| Jun 14, 2021 | ROi CPS LLC Regard NEWBORN KIT, LD00201M, Item Number: 830016013. Medical convenience kit which includes an infant heel warmer. Terminated |
MLS | None listed |
| Jun 14, 2021 | ROi CPS LLC Regard NEWBORN KIT, LD00201K, Item Number: 830016011. Medical convenience kit which includes an infant heel warmer. Terminated |
MLS | None listed |
| Jun 14, 2021 | ROi CPS LLC Regard NEWBORN KIT, LD00201j, Item Number: 830016010. Medical convenience kit which includes an infant heel warmer. Terminated |
MLS | None listed |
| Dec 2, 2020 | ROi CPS LLC Regard - Product Usage: Obstetric Gynecologic specialized manual instrument. Labor and delivery kits. Terminated |
MLS | None listed |
| Sep 3, 2015 | Customed, Inc OB PACK CS/4
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
MLS | None listed |
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