Olsen Medical

FDA Regulatory Profile

Summary

Total Recalls
5
510(k) Clearances
5
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1942-2018Class IISymmetry Olsen bipolar cord: (a) Bipolar Cord, Twin Pin Connector to Shrouded Instrument Connector,May 11, 2018
Z-1941-2018Class IISymmetry Olsen Monopolar Pencil: (a) Button Switchpen, w/ Standard Needle Electrode REF 75505, QTY May 11, 2018
Z-1945-2018Class IISymmetry Olsen monopolar forceps: (a) Insulated Potts-Smith Forceps 8" (20.3cm) Serrated Tips, REFMay 11, 2018
Z-1943-2018Class IISymmetry Olsen monopolar cord: (a) Monopolar Cord, 1/8" Diameter Pin, TUR Connector, 10' (3.0m), RMay 11, 2018
Z-1944-2018Class IISymmetry Olsen bipolar forceps: (a1) Insulated Irrigating Bayonet Forceps 6.25" (15.9cm) Smooth 0.May 11, 2018

Recent 510(k) Clearances

K-NumberDeviceDate
K130669SINGLE USE & MULTI USE BIPOLAR FORCEPS / SINGLE USE & MULTI USE MONOPOLAR FORCEPSDecember 6, 2013
K111262ELECTROSURGICAL MONOPOLAR CABLE/ADAPTERS, ELECTROSURGICAL BIPOLAR CABLE/ ADAPTERS, BIPOLAR ELECTROSUMay 23, 2012
K080187OLSEN MEDICAL SINGLE USE BAYONET BIPOLAR IRRIGATING FORCEPSMay 9, 2008
K072937OLSEN MEDICAL INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SETDecember 28, 2007
K042073OLSEN MEDICAL ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEMFebruary 7, 2005