ClearanceBrief
Company ยท US

Madison Polymeric Engineering

FDA 510(k) clearances and medical device recalls filed under this name, 1997 to 1997. Name variants (Inc, Corp, punctuation) are merged.

2510(k) clearances (0 in 12 months)
11recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
MNLAccessories, Cleaning Brushes, For Endoscope10
FRGWrap, Sterilization1
GEIElectrosurgical, Cutting & Coagulation & Accessories1
LKBPad, Alcohol, Device Disinfectant1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
May 6, 1997K964256CYGNUS INSTRUMENT PROTECTORS
Madison Polymeric Engineering
FRG
Feb 14, 1997K965086CYGNUS ELECTROSURGICAL TIP CLEANER
Madison Polymeric Engineering
GEI

Latest recalls

DateFirm and productCodeLinked 510(k)
May 8, 2019Madison Polymeric Engineering
First Step Draco Pad, Product Number EP-4D
Terminated
MNLNone listed
May 8, 2019Madison Polymeric Engineering
Draco Enzymatic Deep-Cleaning Pad with Ready-to-Use Enzymatic Detergent, Product Number HY0305Z
Terminated
MNLNone listed
Dec 14, 2018Madison 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
MNLNone listed
Mar 21, 2018Madison Polymeric Engineering
Draco Enzymatic Deep-Cleaning Pad, Draco Pad infused with Simple2 Enzymatic Detergent, Catologue Number HY0305Z
Terminated
MNLNone listed
Mar 21, 2018Madison 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
MNLNone listed
Mar 21, 2018Madison Polymeric Engineering
First Step Endoscopic Cleaning Pad, 500ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-6
Terminated
MNLNone listed
Mar 21, 2018Madison Polymeric Engineering
First Step Endoscopic Cleaning Pad with 4" Button Brush, 200ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-4B
Terminated
MNLNone listed
Mar 21, 2018Madison Polymeric Engineering
First Step Endoscopic Cleaning Pad, 200ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-4
Terminated
MNLNone listed
Mar 21, 2018Madison Polymeric Engineering
First Step Endoscopic Cleaning Pad, 100ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-3
Terminated
MNLNone listed
Nov 3, 2017Madison 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
MNLNone listed
May 12, 2017Madison Polymeric Engineering
Draco Enzymatic Deep-Cleaning Pad with Enzymatic Detergent Catalogue Number: HY0305Z
Terminated
LKBNone listed
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