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

Catheter Care Tray

Regulation 876.5130

0510(k)s in 12 months (0 all time)
7recalls in 12 months (16 all time)
0recalls that name a 510(k)
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Top companies in OHR

Company510(k)sRecalls
Medline Industries, LP07
MEDLINE INDUSTRIES, LP - Northfield06
Medical Device Technologies, Inc.02
Apogee Medical, Inc01
DateFirm and productCodeLinked 510(k)
Jun 17, 2026Medline Industries, LP
MEDLINE Medical Procedure Kits labeled as: TONSIL PACK CATH, Medline Kit Number/SKU DYNJ65199A
Open, Classified		 OHRNone listed
Jun 17, 2026Medline Industries, LP
MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag, 16 Fr, 1000mL, Medline Product Number/SKU (REF) URO4RR16C
Open, Classified		 OHRNone listed
Jun 17, 2026Medline Industries, LP
MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag, 14 Fr, 1000mL, Medline Product Number/SKU (REF) URO4RR14C
Open, Classified		 OHRNone listed
Jun 17, 2026Medline Industries, LP
MEDLINE Urethral Catheterization Tray and Bag, Red Rubber Latex, 15 Fr, Medline Product Number/SKU (REF) DYND18350
Open, Classified		 OHRNone listed
Jun 17, 2026Medline Industries, LP
MEDLINE Pre-connected Urethral Catheterization Tray and Bag, Red Rubber Latex, 15 Fr, Medline Product Number/SKU (REF) DYND10407
Open, Classified		 OHRNone listed
Jun 17, 2026Medline Industries, LP
MEDLINE Urethral Catheterization Tray, Red Rubber Latex, Medline Product Number/SKU (REF), French sizes: 1. DYNC1816, 15 Fr; 2. DYND10350, 15 Fr.
Open, Classified		 OHRNone listed
Nov 14, 2025Medline Industries, LP
MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597
Open, Classified		 OHRNone listed
Dec 5, 2024MEDLINE INDUSTRIES, LP - Northfield
MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597
Open, Classified		 OHRNone listed
Oct 23, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline CENTRAL CATHETER INSERTION TRA, REF CVI680C; medical procedure convenience kit
Open, Classified		 OHRNone listed
Sep 6, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits labeled as: 1) CVC INSERTION PACK, Pack Number CVI4720A ; 2) CVC INSERTION PACK, Pack Number CVI4720AH; 3) CATHETER INSERTION KIT CLABSI , Pack Number CVI4880; 4) CHEST I
Open, Classified		 OHRNone listed
Feb 25, 2024MEDLINE INDUSTRIES, LP - Northfield
MEDLINE Kits, trays, and packs labeled as follows: CATHETERIZATION KIT, REF DYNDA2939
Open, Classified		 OHRNone listed
Aug 3, 2023MEDLINE INDUSTRIES, LP - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CENTRAL CATHETER INSERTION TRAY, Model Number: CVI680C; b. CVC INSERTION ACCESSORY
Open, Classified		 OHRNone listed
Jul 20, 2023MEDLINE INDUSTRIES, LP - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATHETER INSERTION KIT CLABSI, Model Number CVI4880; b) CENTRAL CATHETER INSERTION TRA, Model Number CVI680C
Open, Classified		 OHRNone listed
Nov 18, 2011Medical Device Technologies, Inc.
Angiotech***HSG Procedure Tray 7Fr***1 - 18ga x 1-1/2" Needle; 1 - Fenestrated Drape; 1- 20cc Syringe L/L; 1 - Povidone-Iodine Ointment (1g); 2 - Povidone-Iodine Solution (1oz); 1 - Sanitary Napkin; 2
Terminated		 OHRNone listed
Nov 18, 2011Medical Device Technologies, Inc.
Angiotech***HSG Procedure Tray 5Fr***1 - 18ga x 1-1/2" Needle; 1 - Fenestrated Drape; 1- 20cc Syringe L/L; 1 - Povidone-Iodine Ointment (1g); 2 - Povidone-Iodine Solution (1oz); 1 - Sanitary Napkin; 2
Terminated		 OHRNone listed
May 3, 2011Apogee Medical, Inc
Catheter Insertion Kit (containing, Under pad, PVP Pad, BZK Prep Pad, Sterile Lubricating Jelly, Vinyl Gloves and Poly Zipper Bag). Intended usage: Kit components to be used during Intermittent Urina
Terminated		 OHRNone listed

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