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)
Top companies in FDE
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 26, 2024 | American 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 |
FDE | None listed |
| Oct 26, 2023 | American Contract Systems, Inc. Robotics Pack SAH, REF SAR530M Open, Classified |
FDE | None listed |
| Oct 10, 2023 | Cardinal 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 |
FDE | 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. ABLATION PACK, Model Number: DYNJ40629B;
b. AV FISTULA PACK, Model Number: DYNJ814 Open, Classified |
FDE | 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 CDS840214Q;
b) MINOR PROCEDURE TRAY, Model Number DYNDA2418;
c) CLOSUREFA Open, Classified |
FDE | None listed |
| Apr 25, 2023 | ROi CPS LLC Sterile surgical convenience kits:
1. regard Item Number: 880405003, GS01011C - General Laparoscopy;
2. regard Item Number: 880424004, GS01031D - Thoracic. Open, Classified |
FDE | None listed |
| Feb 6, 2023 | MEDLINE 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 |
FDE | None listed |
| Jan 27, 2023 | MEDLINE INDUSTRIES, LP - Northfield Non-sterile procedural trays labeled as LAPAROTOMY CDS, 2 per case Open, Classified |
FDE | None listed |
| Jan 27, 2023 | MEDLINE INDUSTRIES, LP - Northfield Non-sterile procedural trays labeled as LAPAROSCOPIC, 2 per case Open, Classified |
FDE | None listed |
| Nov 23, 2022 | ROi CPS LLC regard PEDIATRIC UROLOGY, GS00467J, Item Number 880306010; uro surgery convenience kit Terminated |
FDE | None listed |
| Nov 23, 2022 | ROi CPS LLC regard DAVINCI PACK, GS00137W, Item Number 880132023; gastric surgery convenience kit Terminated |
FDE | None listed |
| Jun 16, 2022 | American Contract Systems, Inc. Various Laparoscopy Packs Open, Classified |
FDE | None listed |
| Jun 6, 2022 | MEDLINE INDUSTRIES, LP - SPT Brand Name: Medline
Product Name: convenience kits labeled as: LAP CHOLE
Model/Catalog Number: DYNJ907150 Open, Classified |
FDE | None listed |
| May 3, 2022 | ROi CPS LLC Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG.
CONMED Catalog No. 60-5274-944-Needle w/ Stealth ER, 44cm, 5mm Terminated |
FDE | K952204 |
| Mar 22, 2022 | American Contract Systems, Inc. ACS Lap Chole Pack Open, Classified |
FDE | None listed |
| Nov 13, 2020 | Medline 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 |
FDE | None listed |
| Apr 13, 2020 | American Contract Systems Custom Packs to be used in surgical procedures. Terminated |
FDE | None listed |
| Feb 11, 2020 | Medline Industries Inc Medline
ROBOTIC-LF
REF CDS984543B
Lot 20AKA927 Expiration 2020-09-30
GTIN (01)10888277056350 Terminated |
FDE | None listed |
| Sep 3, 2015 | Customed, 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 |
FDE | None listed |
| Sep 3, 2015 | Customed, 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 |
FDE | None listed |
| Sep 3, 2015 | Customed, 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 |
FDE | None listed |
| Sep 3, 2015 | Customed, 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 |
FDE | None listed |
| Sep 3, 2015 | Customed, 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 |
FDE | None listed |
| Sep 3, 2015 | Customed, 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 |
FDE | None listed |
| Sep 3, 2015 | Customed, 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 |
FDE | None listed |
| Sep 3, 2015 | Customed, 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 |
FDE | None listed |
| Sep 3, 2015 | Customed, 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 |
FDE | None listed |
| Sep 3, 2015 | Customed, 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 |
FDE | None listed |
| Sep 3, 2015 | Customed, 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 |
FDE | None listed |
| Sep 3, 2015 | Customed, 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 |
FDE | None listed |
| Sep 3, 2015 | Customed, 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 |
FDE | None listed |
| Sep 3, 2015 | Customed, 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 |
FDE | None listed |
| Dec 16, 2014 | Customed, 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 |
FDE | None listed |
| Dec 16, 2014 | Customed, 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 |
FDE | None listed |
| Dec 16, 2014 | Customed, 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 |
FDE | None listed |
| Dec 16, 2014 | Customed, 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 |
FDE | None listed |
| Dec 16, 2014 | Customed, 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 |
FDE | None listed |
| Dec 16, 2014 | Customed, 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 |
FDE | None listed |
| Dec 16, 2014 | Customed, 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 |
FDE | None listed |
| Dec 16, 2014 | Customed, 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 |
FDE | None listed |
| Dec 16, 2014 | Customed, 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 |
FDE | None listed |
| Dec 16, 2014 | Customed, 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 |
FDE | None listed |
| Dec 16, 2014 | Customed, 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 |
FDE | None listed |
| Dec 16, 2014 | Customed, 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 |
FDE | None listed |
| Dec 16, 2014 | Customed, 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 |
FDE | None listed |
| Dec 16, 2014 | Customed, 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 |
FDE | None listed |
| Dec 16, 2014 | Customed, 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 |
FDE | None listed |
| Dec 16, 2014 | Customed, 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 |
FDE | None listed |
| Dec 16, 2014 | Customed, 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 |
FDE | None listed |
| Dec 16, 2014 | Customed, 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 |
FDE | None listed |
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