Medical Device Manufacturer · US , Lake Success , NY

Olympus America, Inc. - FDA 510(k) Cleared Devices

149 submissions · 149 cleared · Since 1994
149
Total
149
Cleared
0
Denied
149 devices
26-50 of 149
Cleared May 02, 2002
VISERA CYSTOVIDEOSCOPE OLYMPUS CYF TYPE V/VA
K021074 · FAJ
Gastroenterology & Urology · 30d
Cleared May 01, 2002
VISERA RHINLARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V
K021073 · EOB
Ear, Nose, Throat · 29d
Cleared Feb 08, 2002
OLYMPUS HDL CHOLESTEROL REAGENT
K014015 · LBS
Chemistry · 65d
Cleared Feb 08, 2002
OLYMPUS LDL CHOLESTEROL REAGENT, OLYMPUS LDL CHOLESTEROL CALIBRATOR, OLYMPUS...
K014032 · LBS
Chemistry · 64d
Cleared Dec 11, 2001
HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE
K013066 · MND
Gastroenterology & Urology · 90d
Cleared Aug 27, 2001
OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CTR, EUS EXERA ULTRASONIC...
K011886 · ODG
Radiology · 73d
Cleared Jun 25, 2001
OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER
K011720 · CIX
Chemistry · 21d
Cleared Feb 27, 2001
OLYMPUS ENDOSCOPIC LIGATION DEVICE
K001744 · MND
Gastroenterology & Urology · 264d
Cleared Dec 18, 2000
MODIFICATION TO OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER
K003721 · JJE
Chemistry · 14d
Cleared Oct 25, 2000
OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT
K002918 · DCN
Immunology · 36d
Cleared Oct 25, 2000
OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER
K002982 · JJE
Chemistry · 30d
Cleared Sep 05, 2000
OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR...
K994103 · ITX
Radiology · 274d
Cleared Jun 02, 2000
OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR...
K994069 · ITX
Radiology · 183d
Cleared Jun 02, 2000
OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR...
K994106 · ITX
Radiology · 179d
Cleared Nov 03, 1999
OLYMPUS NA-10J-KB ASPIRATION NEEDLE
K991672 · FCG
Gastroenterology & Urology · 170d
Cleared Sep 17, 1999
OLYMPUS DISTAL ATTACHMENT, MODELS...
K984358 · FDS
Gastroenterology & Urology · 284d
Cleared Aug 19, 1999
OLYMPUS SERUM PROTEIN MULTICALIBRATOR 2
K992086 · JIX
Toxicology · 59d
Cleared Jul 12, 1999
TROCAR SYSTEM ACCORDING TO HASSON
K990237 · GCJ
General & Plastic Surgery · 169d
Cleared May 11, 1999
B-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEM
K991136 · JZG
Immunology · 36d
Cleared Feb 24, 1999
BIPOLAR GRASPING FORCEPS BIQ+
K984417 · GEI
General & Plastic Surgery · 76d
Cleared Dec 11, 1998
OLYMPUS UM 2R/3R ULTRASONIC PROBES AND ASSOCIATED ANCILLARY EQUIPMENT, FOR...
K982323 · ITX
Radiology · 162d
Cleared Oct 23, 1998
OLYMPUS MH-246R BALLOON SHEATH, FOR FEMALE REPRODUCTIVE TRACT USE
K982725 · ITX
Radiology · 79d
Cleared Aug 19, 1998
HEAT PROBE UNIT HPU-20, HEAT PROBE CD-110##/120##
K982289 · KNS
Gastroenterology & Urology · 50d
Cleared Jun 09, 1998
OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER
K981743 · CKB
Chemistry · 22d
Cleared May 07, 1998
OLYMPUS SERUM PROTEIN MULTICALIBRATOR
K981305 · JIX
Chemistry · 27d

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