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
101-125 of 149
Cleared Jan 24, 1996
OLYMPUS FD-1/2-1 HOT BIOPSY FORCEPS
K955052 · KGE
Gastroenterology & Urology · 79d
Cleared Jan 24, 1996
OLYMPUS FB SERIES BIOPSY FORCEPS
K955065 · FCL
Gastroenterology & Urology · 79d
Cleared Jan 22, 1996
OLYMPUS BASKET GRASPERS
K955063 · OCZ
Gastroenterology & Urology · 77d
Cleared Jan 18, 1996
OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS
K955051 · OCZ
Gastroenterology & Urology · 73d
Cleared Dec 20, 1995
3D SURGICAL ENDOSCOPY SYSTEM FOR UROLOGY
K943304 · FCG
Gastroenterology & Urology · 530d
Cleared Dec 20, 1995
3D SURGICAL ENDOSCOPY SYSTEM FOR GENERAL SURGERY
K943307 · GCJ
General & Plastic Surgery · 530d
Cleared Dec 19, 1995
OLYMPUS HIGH FLOW INSUFFLATION UNIT
K953162 · HIF
Obstetrics & Gynecology · 165d
Cleared Dec 15, 1995
OLYMPUS FG-45/46-1 GRASPING FORCEPS
K955049 · FFL
Gastroenterology & Urology · 39d
Cleared Nov 22, 1995
XCHF-33 CHOLEDOCHOFIBERSCOPE
K944473 · FBN
Gastroenterology & Urology · 439d
Cleared Nov 17, 1995
OLYMPUS 3D SURGICAL ENDOSCOPY SYSTEM
K943305 · HET
Obstetrics & Gynecology · 497d
Cleared Oct 31, 1995
OLYMPUS SUPERVIEW LAPAROSCOPE FOR OB/GYN
K942838 · HET
Obstetrics & Gynecology · 503d
Cleared Oct 20, 1995
OLYMPUS ANTI-STERPTOLYSIN O IMMUNOTURBIDIMETRIC REAGENT
K953437 · GTQ
Microbiology · 91d
Cleared Oct 07, 1995
OLYMPUS AUTOMATIC SURGICAL IRRIGATION PUMP
K953290 · KZD
General Hospital · 85d
Cleared Sep 18, 1995
OLYMPUS IMAGEMANAGER SYSTEM VERSION 6.0 FOR WINDOWS
K952888 · LMB
Radiology · 87d
Cleared Sep 15, 1995
HI-Q HAND INSTRUMENTS, OB/GYN USE
K944200 · HET
Obstetrics & Gynecology · 382d
Cleared Aug 24, 1995
ROLLER ELECTRODE
K951863 · FAS
Gastroenterology & Urology · 125d
Cleared Aug 24, 1995
OLYMPUS RHEUMATOID FACTOR IMMUNOTURBIDIMETRIC REAGENT
K953520 · DHR
Immunology · 28d
Cleared Aug 16, 1995
ULTRATHIN URETEROSCOPES
K951855 · FGB
Gastroenterology & Urology · 117d
Cleared Jul 05, 1995
OLYMPUS APOLIPOPROTEIN A1 IMMUNOTURBIDIMETRIC REAGENT
K952425 · JHN
Immunology · 42d
Cleared Jun 14, 1995
OLYMPUS ARTHROSCOPY SYSTEM
K951354 · HRX
Orthopedic · 82d
Cleared Jun 13, 1995
OLYMPUS LAPAROSCOPIC ULTRASOUND SYSTEM
K944017 · ITX
Radiology · 301d
Cleared Jun 13, 1995
OLYMPUS NBD TUBES
K944912 · FGE
Gastroenterology & Urology · 251d
Cleared Jun 05, 1995
OLYMPUS APOLIPOPROTEIN B IMMUNOTURBIDIMETRIC REAGENT
K952466 · JHN
Immunology · 10d
Cleared May 03, 1995
OLYMPUS FD-5 HOT BIOPSY FORCEPS
K951445 · KGE
Gastroenterology & Urology · 35d
Cleared Apr 17, 1995
OLYMPUS IGG IMMUNOTURBIDIMETRIC REAGENT
K951013 · CFQ
Immunology · 42d

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