ClearanceBrief
Panels › Gastroenterology, Urology › Product code FKG · Class 1

Tray, Start/Stop (Including Contents), Dialysis

Regulation 876.5820

0510(k)s in 12 months (6 all time)
1recalls in 12 months (11 all time)
0recalls that name a 510(k)
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Top companies in FKG

Company510(k)sRecalls
MEDLINE INDUSTRIES, LP - Northfield05
Centurion Medical Products03
Lee Medical International Inc02
Argon Medical Corp.10
Cutter Laboratories, Inc.10
Dove Medical Supplies10
J.J. Skinner, Inc.10
Med-Pak Corp.10
Medline Industries, LP01
Professional Dialysis Products10
DateFirm and productCodeLinked 510(k)
Feb 24, 2026Medline Industries, LP
Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746
Open, Classified
FKGNone listed
Sep 6, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits labeled as: 1) VENOUS ACCESS TRAY, Pack Number CVI4830A; 2) DIALYSIS INSERTION BUNDLE-ADD CATHETER, Pack Number CVI4835; 3) DIALYSIS TAKE OFF KIT , Pack Number DT18185; 4
Open, Classified
FKGNone listed
Feb 25, 2024MEDLINE INDUSTRIES, LP - Northfield
Centurion Kits, trays, and packs labeled as follows: a) DIALYSIS ACCESSORY PACK W/O CATHETER, REF MNS10750A; b) DIALYSIS ON KIT, REF DT21235A; c) INFUSA PORT KIT, REF DYNDC3166A
Open, Classified
FKGNone listed
Feb 25, 2024MEDLINE INDUSTRIES, LP - Northfield
Centurion Kits, trays, and packs labeled as follows: a) DIALYSIS ACCESSORY PACK W/O CATHETER, REF MNS10750A; b) DIALYSIS ON KIT, REF DT21235A; c) INFUSA PORT KIT, REF DYNDC3166A
Open, Classified
FKGNone listed
Aug 3, 2023MEDLINE INDUSTRIES, LP - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DIALYSIS ACCESSORY PACK W/O CATHETER, Model Number: MNS10750A; b. STD INSERTION/DI
Open, Classified
FKGNone listed
Jul 20, 2023MEDLINE INDUSTRIES, LP - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: DIALYSIS ACCESSORY PACK W/O CATHETER, Model Number MNS10750A
Open, Classified
FKGNone listed
Sep 23, 2011Lee Medical International Inc
Custom Dialysis prep kits labeled as follows: ADV-CARE-ISL44, 100/CS, LOT #K1018, EXP 5-12, BIN 34B; COMMUNITY-CATH, 150/CS, LOT #K1052, EXP 5-12, BIN 36B; COLUMBUS-CATH, 50/CS, LOT #1080, EXP 05-
Terminated
FKGNone listed
Sep 7, 2011Lee Medical International Inc
Custom dialysis prep kits labeled as follows: KIDNEYCARE, 125/CS, LOT #A1160, EXP 7-12, BIN 35A, Lee Medical International, Inc., New Orleans, LA 70123 MESCALERO-HEMO, 200/CS, LOT #B1113, EXP 8-12,
Terminated
FKGNone listed
Jun 30, 2010Centurion Medical Products
Dialysis Tray, SP560, Sterile, Micropore Surgical Tape, Single Use Rolls, Tri-State Hospital Supply Company Manufacturers of Centurion Healthcare Products Howell, MI
Terminated
FKGNone listed
Jun 30, 2010Centurion Medical Products
C.A.P.D. Tubing Exchange Tray, HT80, Sterile, Micropore Surgical Tape, Single Use Rolls, Tri-State Hospital Supply Company Manufacturers of Centurion Healthcare Products Howell, MI.
Terminated
FKGNone listed
Jun 30, 2010Centurion Medical Products
Dialysis On/Off Kit, DT11300, Sterile, Micropore Surgical Tape, Single Use Rolls, Port Access Dressing Change Tray, Tri-State Hospital Supply Company Manufacturers of Centurion Healthcare Products How
Terminated
FKGNone listed

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