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Panels › Gastroenterology, Urology › Product code FDE · Class 2

Laparoscopy Kit

Regulation 876.1500

0510(k)s in 12 months (4 all time)
22recalls in 12 months (127 all time)
1recalls that name a 510(k)
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Top companies in FDE

DateFirm and productCodeLinked 510(k)
Jan 26, 2024American Contract Systems, Inc.
Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: a) LAP KIDNEY MODULE, kit number AGKD50L; b) ROBOTIC PROSTATE PACK - 264852, kit number ANPR34S; c) LAP
Open, Classified
FDENone listed
Oct 26, 2023American Contract Systems, Inc.
Robotics Pack SAH, REF SAR530M
Open, Classified
FDENone listed
Oct 10, 2023Cardinal Health 200, LLC
Procedure packs: (1) Presource PBDS Cat. PG33BTO21, Ohio State Univ Wexner Med Ctr, Kit, Roux UH, Sterile; (2) Presource PBDS Cat. PG33BTO22, Ohio State Univ Wexner Med Ctr, Kit, Roux UH, Sterile;
Open, Classified
FDENone listed
Aug 3, 2023MEDLINE INDUSTRIES, LP - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ABLATION PACK, Model Number: DYNJ40629B; b. AV FISTULA PACK, Model Number: DYNJ814
Open, Classified
FDENone listed
Jul 20, 2023MEDLINE INDUSTRIES, LP - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETAL SURGERY CDS-LF, Model Number CDS840214Q; b) MINOR PROCEDURE TRAY, Model Number DYNDA2418; c) CLOSUREFA
Open, Classified
FDENone listed
Apr 25, 2023ROi CPS LLC
Sterile surgical convenience kits: 1. regard Item Number: 880405003, GS01011C - General Laparoscopy; 2. regard Item Number: 880424004, GS01031D - Thoracic.
Open, Classified
FDENone listed
Feb 6, 2023MEDLINE INDUSTRIES, LP - Northfield
Sterile Procedural Trays, labeled as the following: a. LAPAROTOMY CDS-LF b. LAPAROSCOPY CDS-LF c. BASIC LAPAROSCOPY CDS d. LAPAROSCOPY CDS-LF e. GENERAL LAPAROSCOPY PROCEDURE f. LAP CHOLE CDS g. COLO
Open, Classified
FDENone listed
Jan 27, 2023MEDLINE INDUSTRIES, LP - Northfield
Non-sterile procedural trays labeled as LAPAROTOMY CDS, 2 per case
Open, Classified
FDENone listed
Jan 27, 2023MEDLINE INDUSTRIES, LP - Northfield
Non-sterile procedural trays labeled as LAPAROSCOPIC, 2 per case
Open, Classified
FDENone listed
Nov 23, 2022ROi CPS LLC
regard PEDIATRIC UROLOGY, GS00467J, Item Number 880306010; uro surgery convenience kit
Terminated
FDENone listed
Nov 23, 2022ROi CPS LLC
regard DAVINCI PACK, GS00137W, Item Number 880132023; gastric surgery convenience kit
Terminated
FDENone listed
Jun 16, 2022American Contract Systems, Inc.
Various Laparoscopy Packs
Open, Classified
FDENone listed
Jun 6, 2022MEDLINE INDUSTRIES, LP - SPT
Brand Name: Medline Product Name: convenience kits labeled as: LAP CHOLE Model/Catalog Number: DYNJ907150
Open, Classified
FDENone listed
May 3, 2022ROi CPS LLC
Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No. 60-5274-944-Needle w/ Stealth ER, 44cm, 5mm
Terminated
FDEK952204
Mar 22, 2022American Contract Systems, Inc.
ACS Lap Chole Pack
Open, Classified
FDENone listed
Nov 13, 2020Medline Industries Inc
Resect. Intest. Laparo-LF, Model DYNJ42667A - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.
Terminated
FDENone listed
Apr 13, 2020American Contract Systems
Custom Packs to be used in surgical procedures.
Terminated
FDENone listed
Feb 11, 2020Medline Industries Inc
Medline ROBOTIC-LF REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTIN (01)10888277056350
Terminated
FDENone listed
Sep 3, 2015Customed, Inc
LAPAROSCOPY-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
FDENone listed
Sep 3, 2015Customed, Inc
LAPAROSCOPY GYN PK CS/4 Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Terminated
FDENone listed
Sep 3, 2015Customed, Inc
LAP-CHOLECYSTECTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Terminated
FDENone listed
Sep 3, 2015Customed, Inc
LAPAROSCOPY 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
FDENone listed
Sep 3, 2015Customed, Inc
LAPAROSCOPY OB 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Terminated
FDENone listed
Sep 3, 2015Customed, Inc
LAPAROSCOPY 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
FDENone listed
Sep 3, 2015Customed, Inc
LAPAROSCOPY CHOLE 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Terminated
FDENone listed
Sep 3, 2015Customed, Inc
LAPAROSCOPY PACK 2/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Terminated
FDENone listed
Sep 3, 2015Customed, Inc
LAPAROSCOPY-COLORECTAL SURGICAL PACK 2/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Terminated
FDENone listed
Sep 3, 2015Customed, Inc
LAPAROS.CHOLE 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Terminated
FDENone listed
Sep 3, 2015Customed, Inc
D & C LAPAROSCOPY 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
FDENone listed
Sep 3, 2015Customed, Inc
LAPAROSCOPY 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
FDENone listed
Sep 3, 2015Customed, Inc
LAPAROSC CHOLE 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Terminated
FDENone listed
Sep 3, 2015Customed, Inc
LAPAROSCOPY PK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Terminated
FDENone listed
Dec 16, 2014Customed, Inc
Laparoscopy Gyn Pack, Catalog number 900-605. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
FDENone listed
Dec 16, 2014Customed, Inc
Laparoscopy Cholecystectomy Surgical Pack, Catalog number 900-576A. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
FDENone listed
Dec 16, 2014Customed, Inc
Laparoscopy Pack, Catalog number 900-486. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
FDENone listed
Dec 16, 2014Customed, Inc
Laparoscopy Pack, Catalog number 900-484 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
FDENone listed
Dec 16, 2014Customed, Inc
Laparoscopy Pack, Catalog number 900-474. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
FDENone listed
Dec 16, 2014Customed, Inc
Laparoscopy Chole Pack, Catalog number 900-414. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
FDENone listed
Dec 16, 2014Customed, Inc
Major Lap Pack, Catalog number 900-404. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
FDENone listed
Dec 16, 2014Customed, Inc
Laparoscopy Pack, Catalog number 900-3178. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
FDENone listed
Dec 16, 2014Customed, Inc
Laparoscopy and Pack (1)(2), catalog #900-2483 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
FDENone listed
Dec 16, 2014Customed, Inc
Laparoscopy Colorectal Surgical Pack, catalog #900-2259A Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
FDENone listed
Dec 16, 2014Customed, Inc
Laparoscopy Chole Pack, Catalog number 900-2004. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
FDENone listed
Dec 16, 2014Customed, Inc
Laparoscopy Pack, Catalog number 900-1967. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
FDENone listed
Dec 16, 2014Customed, Inc
Laparoscopy Premium Pack, Catalog number 900-1803. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
FDENone listed
Dec 16, 2014Customed, Inc
Laparoscopy Chole Pack, Catalog number 900-1688. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
FDENone listed
Dec 16, 2014Customed, Inc
D&C Laparoscopy Pack, Catalog number 900-1496. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
FDENone listed
Dec 16, 2014Customed, Inc
Laparoscopy Pack, Catalog number 900-1176. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
FDENone listed
Dec 16, 2014Customed, Inc
Laparoscopy Chole Pack, Catalog number 900-1059. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
FDENone listed
Dec 16, 2014Customed, Inc
Laparoscopy Pack, Catalog number 900-028. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
FDENone listed

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