Medical Device Manufacturer · US , Melville , NY

Olympus Medical Systems Corporation - FDA 510(k) Cleared Devices

81 submissions · 81 cleared · Since 2004
81
Total
81
Cleared
0
Denied
81 devices
51-75 of 81
Cleared Jul 29, 2009
MODIFICATION TO OLYMPUS CAPSULE ENDOSCOPE SYSTEM
K090210 · NEZ
Gastroenterology & Urology · 182d
Cleared Jan 13, 2009
HD CAMERA HEAD OTV-S7PROH-HD-L08E
K083155 · FET
Gastroenterology & Urology · 81d
Cleared Dec 23, 2008
ENDOSCOPIC CO2 REGULATION UNIT UCR
K081173 · HET
Obstetrics & Gynecology · 243d
Cleared Nov 06, 2008
OLYMPUS CHF TYPE V
K081456 · FBN
Gastroenterology & Urology · 167d
Cleared Nov 05, 2008
TRACHEAL INTUBATION FIBERVIDEOSCOPE, MODELS LF-Y0004 AND LF-Y0005
K082720 · EOQ
Ear, Nose, Throat · 49d
Cleared Oct 21, 2008
XCHF-T160 VIDEOSCOPE
K082576 · FBN
Gastroenterology & Urology · 46d
Cleared Oct 16, 2008
VB IMAGE VIEWER
K080581 · JAK
Radiology · 227d
Cleared Sep 26, 2008
HD ENDOEYE LAPARO-THORACO VIDEOSCOPE OLYMPUS LTF TYPE VH
K080948 · HET
Obstetrics & Gynecology · 176d
Cleared May 20, 2008
XTJF TYPE Q160VF1
K080403 · FDT
Gastroenterology & Urology · 96d
Cleared May 06, 2008
OLYMPUS XCHF TYPE B180Y1
K080586 · FBN
Gastroenterology & Urology · 64d
Cleared Mar 25, 2008
SMALL INTESTINAL VIDEOSCOPE SYSTEM
K071254 · FDA
Gastroenterology & Urology · 326d
Cleared Mar 18, 2008
EVIS EXERA II 180 SYSTEM
K072957 · NWB
Gastroenterology & Urology · 151d
Cleared Sep 14, 2007
OLYMPUS CAPSULE ENDOSCOPE SYSTEM
K063259 · NEZ
Gastroenterology & Urology · 319d
Cleared Jul 05, 2007
OLYMPUS XBF-UC180F-DT8 ULTRASONIC BRONCHOFIBERVIDEOSCOPE USED WITH ALOKA...
K070983 · PSV
Radiology · 90d
Cleared Mar 05, 2007
ENDOSCOPIC INSUFFLATION UNIT, MODEL XECR-2
K063786 · FCX
Gastroenterology & Urology · 74d
Cleared Feb 08, 2007
OLYMPUS XEU-M60A ENDOSCOPIC ULTRASOUND CENTER
K063683 · IYN
Radiology · 58d
Cleared Dec 22, 2006
ELECTROSURGICAL HEMOSTATIC FORCEPS SERIES
K062517 · KGE
Gastroenterology & Urology · 116d
Cleared Sep 22, 2006
EVIS EXERA II 180 SYSTEM
K062049 · NWB
Gastroenterology & Urology · 64d
Cleared Aug 31, 2006
EVIS EXERA 180 SYSTEM
K061313 · EOQ
Ear, Nose, Throat · 113d
Cleared Jun 23, 2006
OLYMPUS GUIDE SHEATH, MODEL XBO1-836-13
K060243 · EOQ
Ear, Nose, Throat · 143d
Cleared May 26, 2006
LAPARO-THORACO VIDEOSCOPE XLTF-VAW
K053382 · GCJ
General & Plastic Surgery · 172d
Cleared Mar 17, 2006
EVIS EXERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE, OLYMPUS MODEL BF TYPE UC160F-OL8
K060475 · ODB
Radiology · 22d
Cleared Nov 14, 2005
OLYMPUS CHOLEDOCHOSCOPE, MODEL XCHF-BP160F
K051886 · FBN
Gastroenterology & Urology · 125d
Cleared Oct 13, 2005
EVIS EXERA 160A SYSTEM
K051645 · NWB
Gastroenterology & Urology · 115d
Cleared Sep 21, 2005
VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT
K052452 · EOB
Ear, Nose, Throat · 15d

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