510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Conmed Endoscopic Technologies, Inc.

Billerica, MA, US

Conmed Endoscopic Technologies, Inc. appears in FDA device records in Billerica, MA. FDA records list 2 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 19 recalls for this company.

FDA records held for this company

510(k) clearances
2
PMA records
0
Recall records
19
Registered establishments
0

FDA records under these names

1 name

FDA records resolved to Conmed Endoscopic Technologies, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Bard Endoscopic Technologiesrecall

510(k) clearance history

FDA records hold 2 510(k) clearances for Conmed Endoscopic Technologies, Inc. between 2008 and 2009. The busiest year on record is 2008, with 1. The most recent is 2009, with 1.

Clearances by year, as a table
510(k) clearance decisions for Conmed Endoscopic Technologies, Inc., by decision year
YearClearances
20081
20091
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K091355DEUCE POLYPECTOMY SNARE, MODELS 000995, 000996,000997, 000998FDISubstantially Equivalent
K080946CONMED AXCESS PAPILLOTOME MODELS AX4535, AX4535FXKNSSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0949-2007ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 20mm (60 Fr), length 4cm; product code/end item #000861 and #000867 (5 pack); Single Use, Non-Sterile; distributed by ConMed Endoscopic Technologies, Billerica, MA 01821.Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.Terminated
Z-0948-2007ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 18mm (54 Fr), length 4cm; product code/end item #000849 and #000859 (5 pack); Single Use, Non-Sterile; distributed by ConMed Endoscopic Technologies, Billerica, MA 01821.Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.Terminated
Z-0947-2007ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 15mm (45 Fr), length 4cm; product code/end item #000848 and #000858 (5 pack); Single Use, Non-Sterile; distributed by ConMed Endoscopic Technologies, Billerica, MA 01821.Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.Terminated
Z-0946-2007ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 12mm (36 Fr), length 4cm; product code/end item #000847 and #000857 (5 pack); Single Use, Non-Sterile; distributed by ConMed Endoscopic Technologies, Billerica, MA 01821.Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.Terminated
Z-0945-2007ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 10mm (30 Fr), length 4cm; product code/end item #000846; Single Use, Non-Sterile; distributed by ConMed Endoscopic Technologies, Billerica, MA 01821.Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.Terminated
Z-0944-2007ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 8mm (24 Fr), length 4cm; product code/end item #000845; Single Use, Non-Sterile; distributed by ConMed Endoscopic Technologies, Billerica, MA 01821.Complaints received regarding PET Balloon Dilators for a variety of labeling errors, including: incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.Terminated
Z-0943-2007ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 6mm (18 Fr), length 4cm; product code/end item #000844; Single Use, Non-Sterile; distributed by ConMed Endoscopic Technologies, Billerica, MA 01821.Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.Terminated
Z-0942-2007ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 20mm (60 Fr), length 8cm; product code/end item #000380 and #000379 (5 pack); Single Use, Non-Sterile; distributed by ConMed Endoscopic Technologies, Billerica, MA 01821.Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.Terminated
Z-0941-2007ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 18mm (54 Fr), length 8cm; product code/end item #000345 and #000736 (5 pack); Single Use, Non-Sterile; distributed by ConMed Endoscopic Technologies, Billerica, MA 01821.Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.Terminated
Z-0940-2007ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 15mm (45 Fr), length 8cm; product code/end item #000344 and #000735 (5 pack); Single Use, Non-Sterile; distributed by ConMed Endoscopic Technologies, Billerica, MA 01821.Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.Terminated
Z-0939-2007ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 12mm (36 Fr), length 8cm; product code/end item #000343 and #000443 (5 pack); Single Use, Non-Sterile; distributed by ConMed Endoscopic Technologies, Billerica, MA 01821.Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.Terminated
Z-0938-2007ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 10mm (30 Fr), length 8cm; product code/end item #000342; Single Use, Non-Sterile; distributed by ConMed Endoscopic Technologies, Billerica, MA 01821.Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.Terminated
Z-0937-2007ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 8mm (24 Fr), length 8cm; product code/end item #000341; Single Use, Non-Sterile; distributed by ConMed Endoscopic Technologies, Billerica, MA 01821.Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.Terminated
Z-0730-2007Flexxus™ Endoscopic Biliary Stent, 7.5 Fr 10 mm diameter x 60 mm length Item Number: LXB10060Blue safety clip incorrectly placed on the stent may prevent deploymentTerminated
Z-0729-2007Flexxus™ Endoscopic Biliary Stent, 7.5 Fr 10mm diameter x 40 mm length Item Number: LXB10040Blue safety clip incorrectly placed on the stent may prevent deploymentTerminated
Z-1233-03Bard PEG Safety System ''Guidewire'' Reorder Number: 001928Mislabeled kit: Prefilled Lidocaine syringe is labeled 'sterile fluid path only', outer label states kit content is sterileTerminated
Z-1232-03Bard Ponsky PEG Safety System ''Pull'' Reoder Number: 001927Mislabeled kit: Prefilled Lidocaine syringe is labeled 'sterile fluid path only', outer label states kit content is sterileTerminated
Z-1231-03Bard Ponsky PEG Safety System ''Pull'' Reorder Number: 001925Mislabeled kit: Prefilled Lidocaine syringe is labeled 'sterile fluid path only', outer label states kit content is sterileTerminated
Z-1230-03Bard PEG Safety System ''Guidewire'' Reorder Number: 000930Mislabeled kit: Prefilled Lidocaine syringe is labeled 'sterile fluid path only', outer label states kit content is sterileTerminated

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Data as of , FDA export datePage updated Source: openFDA, public domain