ClearanceBrief
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)
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Top companies in MLS

DateFirm and productCodeLinked 510(k)
Aug 31, 2026Medline Industries, LP
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators LABOR CDS CDS981762B VAG DELIVERY ADMISSION BAG DYKA1054F
Open, Classified
MLSNone listed
Aug 31, 2026Medline Industries, LP
Medline Convenience Kits: 1) LABOR CDS, Model Number: CDS981762B; 2) VAG DELIVERY ADMISSION BAG, Model Number: DYKA1054F
Open, Classified
MLSNone listed
Jun 29, 2026Medline Industries, LP
Medline Convenience Kits: 1) L&D CONTINUOUS EPIDURAL TRAY, Model Number: PAIN1699A
Open, Classified
MLSNone listed
Jun 17, 2026Medline 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
MLSNone listed
Jun 12, 2026Medline Industries, LP
Medline convenience kit: (82)LABOR & DELIVERY C-SECTION DYNJ907895F
Open, Classified
MLSNone listed
May 7, 2026Medline 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
MLSNone listed
Apr 17, 2026Medline Industries, LP
Medline Kits: 1) LABOR PACK-22025208-LF, Model Number: DYNJ44813D
Open, Classified
MLSNone listed
Apr 7, 2026Medline 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
MLSNone listed
Feb 17, 2026Medline 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
MLSNone listed
Nov 14, 2025Medline Industries, LP
MEDLINE convenience kits labeled as: 1) MAJOR VAGINAL HARPER PACK-LF, REF DYNJ0161768G; 2) ACH MAJOR VAGINAL PACK, REF DYNJ67757B.
Open, Classified
MLSNone listed
Oct 16, 2025American 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
MLSNone listed
Aug 28, 2025American 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
MLSNone listed
Apr 17, 2025MEDLINE 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
MLSNone listed
Mar 25, 2025MEDLINE 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
MLSNone listed
Mar 14, 2025American Contract Systems Inc
DELIVERY PACK , Model No SGDV22D-01 SGDV22E
Open, Classified
MLSNone listed
Mar 14, 2025American Contract Systems Inc
LABOR & DELIVERY PPS , Model No LLLD64O LLLD64O-01 LLLD64O-02
Open, Classified
MLSNone listed
Mar 14, 2025American Contract Systems Inc
BORN ON ARRIVAL KIT , Model No LLBN11B
Open, Classified
MLSNone listed
Mar 14, 2025American Contract Systems Inc
LABOR & DELIVERY PACK, Model Nos LLLD19H
Open, Classified
MLSNone listed
Feb 4, 2025ROi 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
MLSNone listed
Dec 30, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline custom medical procedure kits labeled as: DEEP BRAIN STIMULATION PACK-LF
Open, Classified
MLSNone listed
Dec 5, 2024MEDLINE 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
MLSNone listed
Nov 22, 2024MEDLINE 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
MLSNone listed
Oct 23, 2024MEDLINE 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
MLSNone listed
Sep 24, 2024American Contract Systems, Inc.
Vaginal Delivery, ASDV25B; Medical convenience kit
Open, Classified
MLSNone listed
Sep 24, 2024American Contract Systems, Inc.
Endovascular AAA Pack, ESED52B; Medical convenience kit
Open, Classified
MLSNone listed
Sep 6, 2024MEDLINE 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
MLSNone listed
Aug 28, 2024MEDLINE 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
MLSNone listed
Aug 28, 2024MEDLINE 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
MLSNone listed
Aug 28, 2024MEDLINE 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
MLSNone listed
Jun 28, 2024MEDLINE 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
MLSNone listed
Jun 28, 2024MEDLINE 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
MLSNone listed
Feb 25, 2024MEDLINE 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
MLSNone listed
Jan 26, 2024American 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
MLSNone listed
Aug 3, 2023MEDLINE 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
MLSNone listed
Jul 20, 2023MEDLINE 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
MLSNone listed
Apr 25, 2023ROi CPS LLC
Sterile surgical convenience kit: regard Item Number: 800718003, GY00923C - WPH Major Vaginal Pack.
Open, Classified
MLSNone listed
Feb 6, 2023MEDLINE 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
MLSNone listed
Jun 16, 2022American Contract Systems, Inc.
Various ob/gyn packs
Open, Classified
MLSNone listed
Apr 26, 2022ROi 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
MLSNone listed
Dec 22, 2021ROi CPS LLC
regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles.
Terminated
MLSNone listed
Aug 10, 2021ROi CPS LLC
REGARD Newborn Tray
Terminated
MLSNone listed
Jun 14, 2021ROi CPS LLC
Regard NEWBORN KIT, LD00201M, Item Number: 830016013. Medical convenience kit which includes an infant heel warmer.
Terminated
MLSNone listed
Jun 14, 2021ROi CPS LLC
Regard NEWBORN KIT, LD00201K, Item Number: 830016011. Medical convenience kit which includes an infant heel warmer.
Terminated
MLSNone listed
Jun 14, 2021ROi CPS LLC
Regard NEWBORN KIT, LD00201j, Item Number: 830016010. Medical convenience kit which includes an infant heel warmer.
Terminated
MLSNone listed
Dec 2, 2020ROi CPS LLC
Regard - Product Usage: Obstetric Gynecologic specialized manual instrument. Labor and delivery kits.
Terminated
MLSNone listed
Sep 3, 2015Customed, 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
MLSNone listed

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