Panels › Gastroenterology, Urology › Product code MNL · Class 1
Accessories, Cleaning Brushes, For Endoscope
Regulation 876.1500
0510(k)s in 12 months (4 all time)
0recalls in 12 months (24 all time)
0recalls that name a 510(k)
Top companies in MNL
| Company | 510(k)s | Recalls |
|---|---|---|
| Madison Polymeric Engineering | 0 | 10 |
| MEDLINE INDUSTRIES, LP - Northfield | 0 | 5 |
| Medline Industries Inc | 0 | 3 |
| Endovations | 2 | 0 |
| Healthmark Industries Co., Inc. | 0 | 2 |
| Mckesson Medical-Surgical Inc. Corporate Office | 0 | 2 |
| Cox Medical Ent., Inc. | 1 | 0 |
| Cygnus Medical | 0 | 1 |
| Karl Storz Endovision, Inc. | 0 | 1 |
| Mill-Rose Laboratory | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 5, 2025 | Healthmark Industries Co., Inc. ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample) Open, Classified |
MNL | None listed |
| Jun 5, 2025 | Healthmark Industries Co., Inc. Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010 Open, Classified |
MNL | None listed |
| Mar 19, 2024 | Mckesson Medical-Surgical Inc. Corporate Office Steris Corporation Endo Cleaning Indicator VERIFY" RESITEST" Open, Classified |
MNL | None listed |
| Aug 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office METREX RESEARCH CORP SPONGE, METRISPONGE W/METRIZYME (25/BX 4BX/CS)
Model Number: 10-4025 Open, Classified |
MNL | None listed |
| Apr 21, 2022 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK100FS Open, Classified |
MNL | None listed |
| Apr 21, 2022 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK215FS Open, Classified |
MNL | None listed |
| Apr 21, 2022 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE Polyurethane Bedside Cleaning Kit, REF DYK500FSAW Open, Classified |
MNL | None listed |
| Apr 21, 2022 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK500FS Open, Classified |
MNL | None listed |
| Apr 21, 2022 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE Polyurethane Foam Enzymatic Cleaning Sponge, REF DYK1000TSE Open, Classified |
MNL | None listed |
| Jul 9, 2020 | Medline Industries Inc Endoscopic Cleaning Brush - Product Usage: Endoscopic cleaning brushes are single use devices intended to clean the interior of endoscopes after endoscopy procedures. The brush is threaded through the Terminated |
MNL | None listed |
| May 8, 2019 | Madison Polymeric Engineering First Step Draco Pad, Product Number EP-4D Terminated |
MNL | None listed |
| May 8, 2019 | Madison Polymeric Engineering Draco Enzymatic Deep-Cleaning Pad with Ready-to-Use Enzymatic Detergent, Product Number HY0305Z Terminated |
MNL | None listed |
| Apr 25, 2019 | Medline Industries Inc Endoscopic Cleaning Brushes sold in various Endoscopy Kits - Product Usage: The brushes are used to help clean out the endoscopes in between patient procedures. Terminated |
MNL | None listed |
| Dec 14, 2018 | Madison Polymeric Engineering Draco Enzymatic Deep-Cleaning Pads, Product Number HY0305Z
Product Usage:
Multi-tiered enzymatic detergent contains lipase, carbohydrase, amylase and protease. It effectively dissolves blood, fat, ti Terminated |
MNL | None listed |
| Oct 11, 2018 | Medline Industries Inc Endoscopic Cleaning Brush, single use, sold in kits and labeled as the following:
a. Item Number DYK1002DCB, BRUSH, CLEANING, DOUBLE ENDED, W/ HANDLE - 300 EA/CS, 50EA/BX, 6BX/CS;
b. Item Number Terminated |
MNL | None listed |
| Mar 21, 2018 | Madison Polymeric Engineering Draco Enzymatic Deep-Cleaning Pad, Draco Pad infused with Simple2 Enzymatic Detergent, Catologue Number HY0305Z Terminated |
MNL | None listed |
| Mar 21, 2018 | Madison Polymeric Engineering Travel Kit, First Step EP-4 Kit (200 mL) and 1 Soiled Scope Bag (White), Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number TK-200(W) Terminated |
MNL | None listed |
| Mar 21, 2018 | Madison Polymeric Engineering First Step Endoscopic Cleaning Pad, 500ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-6 Terminated |
MNL | None listed |
| Mar 21, 2018 | Madison Polymeric Engineering First Step Endoscopic Cleaning Pad with 4" Button Brush, 200ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-4B Terminated |
MNL | None listed |
| Mar 21, 2018 | Madison Polymeric Engineering First Step Endoscopic Cleaning Pad, 200ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-4 Terminated |
MNL | None listed |
| Mar 21, 2018 | Madison Polymeric Engineering First Step Endoscopic Cleaning Pad, 100ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-3 Terminated |
MNL | None listed |
| Nov 3, 2017 | Madison Polymeric Engineering First Step Flexible Endoscope Bedside Pre-Clean Kit, EP-4. Intended for pre-clean of outer surface of flexible scopes and surgical instruments to remove gross contamination prior to manual cleaning an Terminated |
MNL | None listed |
| Mar 17, 2016 | Cygnus Medical Cygnus Medical First StepBedside ADDWATER Kit,non-sterile.
First Step in cleaning flexible endoscopes.
SKU# EP-6W
(The First Step 500 ml ADD WATER Kit comes with concentrated Simple2" Enzymatic Deter Terminated |
MNL | None listed |
| Feb 29, 2016 | Karl Storz Endovision, Inc. ENDOSCOPE BRUSH- KARL STORZ Flexible Cleaning Brush single-use, non-sterile device for cleaning various models of endoscopes
Model Number: 11276CL Terminated |
MNL | None listed |
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