Olympus Corp

FDA Filings

This page includes the latest FDA filings for Olympus Corp. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

JAPANTOKYO STOCK EXCHANGE7733DUNS 690536248

Olympus Corp holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number3011170172
FEI Number3011170172
NameFernando DaCosta
Owner & OperatorOlympus Corporation
Contact AddressSHINJUKU MONOLITH 2-3-1 NISHI-SHINJUKU
SHINJUKU-KU, TOKYO JP-NOTA 163-0914 JP
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address48 WOERD AVE
South Waltham, MA 02453 US
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility

Registration Number3009561595
FEI Number3009561595
NameNagano Olympus Co., Ltd.
Owner & OperatorOlympus Corporation
Contact AddressSHINJUKU MONOLITH 2-3-1 NISHI-SHINJUKU
SHINJUKU-KU, TOKYO JP-NOTA 163-0914 JP
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address6666 Inatomi Tatsuno-machi
Kamiina-gun Nagano, 399-0495 JP
Establishment Type
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Manufacture Medical Device

Registration Number3004182751
FEI Number3004182751
NameFernando DaCosta
Owner & OperatorOlympus Corporation
Contact AddressSHINJUKU MONOLITH 2-3-1 NISHI-SHINJUKU
SHINJUKU-KU, TOKYO JP-NOTA 163-0914 JP
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address48 Woerd Ave
South Waltham, MA 02453 US
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility

Registration Number3010367859
FEI Number3010367859
NameFernando DaCosta
Owner & OperatorOlympus Corporation
Contact AddressSHINJUKU MONOLITH 2-3-1 NISHI-SHINJUKU
SHINJUKU-KU, TOKYO JP-NOTA 163-0914 JP
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address48 Woerd Ave
South Waltham, MA 02453 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)

Registration Number2429304
FEI Number2429304
NameOLYMPUS Corporation of the Americas
Owner & OperatorOlympus Corporation
Contact AddressSHINJUKU MONOLITH 2-3-1 NISHI-SHINJUKU
SHINJUKU-KU, TOKYO JP-NOTA 163-0914 JP
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address3500 CORPORATE PKWY.
CENTER VALLEY, PA 18034 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198

FDA Owner/Operator Registration

FDA Filings

Device
Company
DeviceDate
OLYMPUS CORPORATION
 UIS2 OBJECTIVE LENS FOR BIOLOGY 2020-09-29
OLYMPUS CORPORATION
 UIS2 OBJECTIVE LENS FOR BIOLOGY 2020-09-29
OLYMPUS CORPORATION
 UIS2 OBJECTIVE LENS FOR BIOLOGY 2020-09-29
OLYMPUS CORPORATION
 MOTORIZED MIDDLE LONG WORKING DISTANCE CONDENSER 2020-09-29
OLYMPUS CORPORATION
 MID LONG WORKING DISTANCE CONDENSER 2020-09-29
OLYMPUS CORPORATION
 MECHANICAL STAGE WITH RIGHT HANDLE 2020-09-29
OLYMPUS CORPORATION
 CENTERING TELESCOPE 2020-09-29
OLYMPUS CORPORATION
 EYEPIECE 2020-09-29
OLYMPUS CORPORATION
 EYEPIECE 2020-09-29
OLYMPUS CORPORATION
 TILTING BINOCULAR TUBE 2020-09-29
OLYMPUS CORPORATION
 ANALYZER SLIDER 2020-09-29
OLYMPUS CORPORATION
 25 PERCENT ND FILTER 2020-09-29
OLYMPUS CORPORATION
 6 PERCENT ND FILTER 2020-09-29
OLYMPUS CORPORATION
 LBD FILTER 2020-09-29
OLYMPUS CORPORATION
 FROST FILER 45MM 2020-09-29
OLYMPUS CORPORATION
 EXTENSION CORD 2020-09-29
OLYMPUS CORPORATION
 POWER SUPPLY UNIT 2020-09-29
OLYMPUS CORPORATION
 100W HALOGEN LAMP HOUSING 2020-09-29
OLYMPUS CORPORATION
 LED POWER SUPPLY 2020-09-29
OLYMPUS CORPORATION
 LED LAMP HOUSE 2020-09-29
OLYMPUS CORPORATION
 'TRANSMITTED ILLUMINATOR 2020-09-29
OLYMPUS CORPORATION
 CODED INTERMEDIATE MAGNIFICATION CHANGER 2020-09-29
OLYMPUS CORPORATION
 INTERFACE CABLE, 200 CM 2020-09-29
OLYMPUS CORPORATION
 HAND SWITCH 2020-09-29
OLYMPUS CORPORATION
 CONTROL BOX M 2020-09-29
OLYMPUS CORPORATION
 D6RES CABLE,100 CM 2020-09-29
OLYMPUS CORPORATION
 MOTORIZED 6 POSITION NOSEPIECE 2020-09-29
OLYMPUS CORPORATION
 CODED 6 POSITION NOSEPIECE 2020-09-29
OLYMPUS CORPORATION
 IX73 2PORT FRAME 2020-09-29
OLYMPUS CORPORATION
 UNIVERSAL PLAN SEMI-APOCHROMATIC OBJECTIVE LENS 2020-09-29
OLYMPUS CORPORATION
 12 V, 100 W LONG-LIFE HALOGEN BULB 2020-09-29
Nagano Olympus Co., Ltd. [Olympus Corporation]
IX73SC2019-04-15
Fernando DaCosta [Olympus Corporation]
IX73SC2019-04-15
Fernando DaCosta [Olympus Corporation]
IX73SC2019-04-15
OLYMPUS Corporation of the Americas [Olympus Corporation]
Endocapsule2015-06-04
OLYMPUS Corporation of the Americas [Olympus Corporation]
PK Lap Loop2015-06-04
OLYMPUS Corporation of the Americas [Olympus Corporation]
ESG-4002015-06-04
OLYMPUS Corporation of the Americas [Olympus Corporation]
Hicura Hand Instruments2015-06-04
OLYMPUS Corporation of the Americas [Olympus Corporation]
Thunderbeat2015-06-04
OLYMPUS Corporation of the Americas [Olympus Corporation]
Thunderbeat2015-06-04
OLYMPUS Corporation of the Americas [Olympus Corporation]
Quick Clip Pro2015-06-04
OLYMPUS Corporation of the Americas [Olympus Corporation]
Bicoag Hemostasis Probe2015-06-04
OLYMPUS Corporation of the Americas [Olympus Corporation]
Preloaded Sphincterotome2015-06-04
OLYMPUS Corporation of the Americas [Olympus Corporation]
High Flow Insufflation Unit2015-06-04
OLYMPUS Corporation of the Americas [Olympus Corporation]
High Flow Insufflation Unit2015-06-04
OLYMPUS Corporation of the Americas [Olympus Corporation]
High Flow Insufflation Unit2015-06-04
OLYMPUS Corporation of the Americas [Olympus Corporation]
Thunderbeat2015-06-04
OLYMPUS Corporation of the Americas [Olympus Corporation]
Thunderbeat2015-06-04
OLYMPUS Corporation of the Americas [Olympus Corporation]
Thunderbeat2015-06-04
OLYMPUS Corporation of the Americas [Olympus Corporation]
Single Use Biliary Drainage Stent2015-06-04
OLYMPUS Corporation of the Americas [Olympus Corporation]
ESG-4002015-06-04
OLYMPUS Corporation of the Americas [Olympus Corporation]
HH Resection Electrodes and Button Electrode for Plasma Vaporation2015-06-04
OLYMPUS Corporation of the Americas [Olympus Corporation]
HH Resection Electrodes and Button Electrode for Plasma Vaporation2015-06-04
OLYMPUS Corporation of the Americas [Olympus Corporation]
OER-Pro2015-03-11
OLYMPUS Corporation of the Americas [Olympus Corporation]
OER-Pro2015-03-11
OLYMPUS Corporation of the Americas [Olympus Corporation]
ImageManager and EndoWorks software2009-07-14
Nagano Olympus Co., Ltd. [Olympus Corporation]
CKX31, CX412009-04-30
Nagano Olympus Co., Ltd. [Olympus Corporation]
BX61, BX43, BX53, BX63, IX53, IX73, IX83, CKX53, CX432009-04-30
Fernando DaCosta [Olympus Corporation]
CKX31, CX412009-04-30
Fernando DaCosta [Olympus Corporation]
CKX31, CX412009-04-30
Fernando DaCosta [Olympus Corporation]
BX61, BX43, BX53, BX63, IX53, IX73, IX83, CKX53, CX432009-04-30
Fernando DaCosta [Olympus Corporation]
BX61, BX43, BX53, BX63, IX53, IX73, IX83, CKX53, CX432009-04-30
Nagano Olympus Co., Ltd. [Olympus Corporation]
IX53, IX73, IX83, CKX532009-04-30
Nagano Olympus Co., Ltd. [Olympus Corporation]
CKX312009-04-30
Fernando DaCosta [Olympus Corporation]
IX53, IX73, IX83, CKX532009-04-30
Fernando DaCosta [Olympus Corporation]
IX53, IX73, IX83, CKX532009-04-30
Fernando DaCosta [Olympus Corporation]
CKX312009-04-30
Fernando DaCosta [Olympus Corporation]
CKX312009-04-30
Nagano Olympus Co., Ltd. [Olympus Corporation]
CX412009-04-30
Nagano Olympus Co., Ltd. [Olympus Corporation]
BX61, BX43, BX53, BX63, IX53, IX73, IX83, SZX7, SZX10, SZX16, CKX532009-04-30
Fernando DaCosta [Olympus Corporation]
CX412009-04-30
Fernando DaCosta [Olympus Corporation]
CX412009-04-30
Fernando DaCosta [Olympus Corporation]
BX61, BX43, BX53, BX63, IX53, IX73, IX83, SZX7, SZX10, SZX16, CKX532009-04-30
Fernando DaCosta [Olympus Corporation]
BX61, BX43, BX53, BX63, IX53, IX73, IX83, SZX7, SZX10, SZX16, CKX532009-04-30
Nagano Olympus Co., Ltd. [Olympus Corporation]
SZ51;SZ61;SZX7;SZX10;SZX16;CX23;CKX53;CX33;CX432009-04-30
Nagano Olympus Co., Ltd. [Olympus Corporation]
CKX31;CX31;CX412009-04-30
Nagano Olympus Co., Ltd. [Olympus Corporation]
BX61;BX43;BX46;BX53;BX63;IX53;IX73;IX832009-04-30
Fernando DaCosta [Olympus Corporation]
SZ51;SZ61;SZX7;SZX10;SZX16;CX23;CKX53;CX33;CX432009-04-30
Fernando DaCosta [Olympus Corporation]
SZ51;SZ61;SZX7;SZX10;SZX16;CX23;CKX53;CX33;CX432009-04-30
Fernando DaCosta [Olympus Corporation]
SZ51;SZ61;SZX7;SZX10;SZX16;CX23;CKX53;CX33;CX432009-04-30
Fernando DaCosta [Olympus Corporation]
CKX31;CX31;CX412009-04-30
Fernando DaCosta [Olympus Corporation]
CKX31;CX31;CX412009-04-30
Fernando DaCosta [Olympus Corporation]
CKX31;CX31;CX412009-04-30
Fernando DaCosta [Olympus Corporation]
BX61;BX43;BX46;BX53;BX63;IX53;IX73;IX832009-04-30
Fernando DaCosta [Olympus Corporation]
BX61;BX43;BX46;BX53;BX63;IX53;IX73;IX832009-04-30
Fernando DaCosta [Olympus Corporation]
BX61;BX43;BX46;BX53;BX63;IX53;IX73;IX832009-04-30
OLYMPUS Corporation of the Americas [Olympus Corporation]
ImageManager and EndoWorks software2009-04-14
OLYMPUS Corporation of the Americas [Olympus Corporation]
Image Manager and Endoworks software2009-04-14
OLYMPUS Corporation of the Americas [Olympus Corporation]
EndoWorks2009-04-14
OLYMPUS Corporation of the Americas [Olympus Corporation]
Image Manager and Endoworks software2009-04-14
OLYMPUS Corporation of the Americas [Olympus Corporation]
EndoWorks2009-04-14
OLYMPUS Corporation of the Americas [Olympus Corporation]
ImageManager and Endoworks software2009-04-14
Nagano Olympus Co., Ltd. [Olympus Corporation]
Colposcope OCS series and accessories2007-11-28

Similar & Related FDA Registered Companies

Related Finance Registrations
NCAGE CodeSBA16OLYMPUS CORPORATION
NCAGE Code9L229OLYMPUS CORP OF AMERICA
NCAGE Code8526FOLYMPUS CORPORATION
CAGE CodeSBA16OLYMPUS CORPORATION
CAGE Code9L229OLYMPUS CORP OF AMERICA
SEC0001329942OLYMPUS CORP of JAPAN
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092555429Tokyo ,Japan -> Los Angeles, CaliforniaENDOSCOPIC EQUIPMENT (3923.50)142 CTN
2020092555430Tokyo ,Japan -> Los Angeles, CaliforniaPARTS FOR ENDOSCOPE EQUIPMENT (3917.32)4 CTN
2020091966742Tokyo ,Japan -> Los Angeles, CaliforniaENDOSCOPIC EQUIPMENT (3923.50)238 CTN
2020091930324Tokyo ,Japan -> Los Angeles, CaliforniaENDOSCOPIC EQUIPMENT (8421.29)165 CTN
2020091823631Tokyo ,Japan -> Los Angeles, CaliforniaENDOSCOPIC EQUIPMENT (8421.29)165 CTN
2020091858909Tokyo ,Japan -> Los Angeles, CaliforniaENDOSCOPIC EQUIPMENT (3923.50)238 CTN
2020091813683Tokyo ,Japan -> Los Angeles, CaliforniaENDOSCOPIC EQUIPMENT (3923.50)163 CTN
2020091526201Tokyo ,Japan -> Los Angeles, CaliforniaENDOSCOPIC EQUIPMENT (3923.50)163 CTN
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