Conmed Endoscopic Technologies, Inc.

Medical device manufacturer in Chelmsford, MA.

2510(k) clearances
0PMA approvals
15recalls

Device types

510(k) clearances

510(k)DeviceDecision
K091355Deuce Polypectomy Snare, Models 000995, 000996,000997, 000998FDI · Traditional 07/22/2009SE
K080946Conmed Axcess Papillotome Models AX4535, AX4535FXKNS · Traditional 05/20/2008SE

Recalls

RecallProductInitiated
Z-0949-2007 ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 20mm (60…Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of… 04/16/2007Terminated
Z-0948-2007 ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 18mm (54…Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of… 04/16/2007Terminated
Z-0947-2007 ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 15mm (45…Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of… 04/16/2007Terminated
Z-0946-2007 ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 12mm (36…Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of… 04/16/2007Terminated
Z-0945-2007 ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 10mm (30…Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of… 04/16/2007Terminated
Z-0944-2007 ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 8mm (24…Complaints received regarding PET Balloon Dilators for a variety of labeling errors, including: incorrect… 04/16/2007Terminated
Z-0943-2007 ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 6mm (18…Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of… 04/16/2007Terminated
Z-0942-2007 ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 20mm (60 Fr)…Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of… 04/16/2007Terminated
Z-0941-2007 ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 18mm (54 Fr)…Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of… 04/16/2007Terminated
Z-0940-2007 ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 15mm (45 Fr)…Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of… 04/16/2007Terminated
Z-0939-2007 ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 12mm (36 Fr)…Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of… 04/16/2007Terminated
Z-0938-2007 ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 10mm (30 Fr)…Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of… 04/16/2007Terminated
Z-0937-2007 ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 8mm (24 Fr)…Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of… 04/16/2007Terminated
Z-0730-2007 Flexxus™ Endoscopic Biliary Stent, 7.5 Fr 10 mm diameter x 60 mm length Item Number:…Blue safety clip incorrectly placed on the stent may prevent deployment 03/14/2007Terminated
Z-0729-2007 Flexxus™ Endoscopic Biliary Stent, 7.5 Fr 10mm diameter x 40 mm length Item Number:…Blue safety clip incorrectly placed on the stent may prevent deployment 03/14/2007Terminated