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)
Top companies in FKG
| Company | 510(k)s | Recalls |
|---|---|---|
| MEDLINE INDUSTRIES, LP - Northfield | 0 | 5 |
| Centurion Medical Products | 0 | 3 |
| Lee Medical International Inc | 0 | 2 |
| Argon Medical Corp. | 1 | 0 |
| Cutter Laboratories, Inc. | 1 | 0 |
| Dove Medical Supplies | 1 | 0 |
| J.J. Skinner, Inc. | 1 | 0 |
| Med-Pak Corp. | 1 | 0 |
| Medline Industries, LP | 0 | 1 |
| Professional Dialysis Products | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 24, 2026 | Medline Industries, LP Medline Kits containing Tego Connectors
Medline DIALYSIS ON/OFF KIT
SKU EBSI1746 Open, Classified |
FKG | None listed |
| Sep 6, 2024 | MEDLINE 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 |
FKG | None listed |
| Feb 25, 2024 | MEDLINE 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 |
FKG | None listed |
| Feb 25, 2024 | MEDLINE 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 |
FKG | 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. DIALYSIS ACCESSORY PACK W/O CATHETER, Model Number: MNS10750A;
b. STD INSERTION/DI Open, Classified |
FKG | None listed |
| Jul 20, 2023 | MEDLINE 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 |
FKG | None listed |
| Sep 23, 2011 | Lee 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 |
FKG | None listed |
| Sep 7, 2011 | Lee 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 |
FKG | None listed |
| Jun 30, 2010 | Centurion 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 |
FKG | None listed |
| Jun 30, 2010 | Centurion 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 |
FKG | None listed |
| Jun 30, 2010 | Centurion 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 |
FKG | None listed |
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