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
126-149 of 149
Cleared Apr 17, 1995
OLYMPUS IGA IMMUNOTURBIDIMETRIC REAGENT
K951055 · CFQ
Immunology · 41d
Cleared Apr 10, 1995
OLYMPUS ULTRASONIC PROBES
K944610 · ITX
Radiology · 203d
Cleared Mar 27, 1995
OLYMPUS IGM IMMUNOTURBIDIMETRIC REAGENT
K950900 · CFQ
Immunology · 27d
Cleared Mar 24, 1995
OLYMPUS INORGANIC PHOSPHORUS REAGENT
K944768 · CEO
Chemistry · 178d
Cleared Mar 17, 1995
OLYMPUS PR-23Q DISPOSABLE CANNULA (BALL TIP)
K950729 · ODD
Gastroenterology & Urology · 29d
Cleared Mar 16, 1995
LAPAROSCOPE AND ACCESSORIES FOR OB/GYN
K950232 · HET
Obstetrics & Gynecology · 66d
Cleared Mar 15, 1995
OLYMPUS GLUCOSE REAGENT
K944406 · CFR
Chemistry · 188d
Cleared Mar 06, 1995
LAPAROSCOPE, HAND INSTRUMENTS
K950103 · GCJ
General & Plastic Surgery · 54d
Cleared Mar 06, 1995
OLYMPUS BIOPSY FORCEPS MODEL FB-44
K950786 · EOQ
Ear, Nose, Throat · 13d
Cleared Mar 03, 1995
LAPAROSCOPE
K950076 · GCJ
General & Plastic Surgery · 53d
Cleared Feb 27, 1995
OLYMPUS DISPOSABLE BIOPSY FORCEPS
K950636 · EOQ
Ear, Nose, Throat · 14d
Cleared Feb 22, 1995
OLYMPUS KD-6G1-9Q WIRE GUIDED PAPILLOTOMU KNIFE
K950166 · KNS
Gastroenterology & Urology · 36d
Cleared Feb 21, 1995
A4722 OLYMPUS OPTICAL OBTURATOR
K950055 · HIH
Obstetrics & Gynecology · 46d
Cleared Feb 09, 1995
OLYMPUS 5FR SEMI-RIGID SCISSORS FOR OB/GYN
K950036 · HIH
Obstetrics & Gynecology · 36d
Cleared Feb 01, 1995
LAPAROSCOPE AND ACCESSORIES FOR GENERAL SURGERY
K950231 · GCJ
General & Plastic Surgery · 23d
Cleared Feb 01, 1995
MINI LAPAROSCOPY FOR GENERAL SURGERY
K950278 · GCJ
General & Plastic Surgery · 8d
Cleared Jan 11, 1995
OLYMPUS NASAL AND SINUS ENDOSCOPES
K944072 · EOB
Ear, Nose, Throat · 142d
Cleared Jan 05, 1995
CALCIUM REAGENT
K944258 · CIC
Chemistry · 126d
Cleared Dec 27, 1994
OLYMPUS MAGNESIUM REAGENT
K944407 · JGJ
Chemistry · 110d
Cleared Dec 09, 1994
OLYMPUS AMYLASE REAGENT
K944229 · JFJ
Chemistry · 100d
Cleared Nov 29, 1994
HI-Q HAND INSTRUMENTS- UROLOGY
K944201 · GCJ
General & Plastic Surgery · 92d
Cleared Nov 14, 1994
OLYMPUS SWITCHING UNIT MODEL SU-1
K944081 · FET
Gastroenterology & Urology · 84d
Cleared Oct 11, 1994
NASAL ENDOSCOPY & SINUSCOPY HAND INSTRUMENTS
K943665 · EOB
Ear, Nose, Throat · 75d
Cleared Jul 27, 1994
OLYMPUS SUPERVIEW LAPAROSCOPE FOR GENERAL SURGERY
K942839 · GCJ
General & Plastic Surgery · 42d

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