Olympus Vietnam Co L T D

FDA Filings

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

FDA Registration(s)

• Registration Number: 3008040402
• FEI Number: 3008040402
• Name: Olympus Vietnam Company Limited
• Owner & Operator: Olympus Medical Systems Corporation
• Contact Address: 2951 Ishikawa-cho ; Hachioji-shi JP-13 Tokyo 192-8507 JP
• US Agent:
  • Troy Quander
  • 508 8044716
  • Troy.quander@olympus-osta.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 8 Street Long Thanh Industrial Zone, Tam An Commune; Long Thanh District Dong Nai, 71000 VN
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN K141991 | KNS Olympus Vietnam Company Limited [Olympus Medical Systems Corporation]	Single Use Sphincterotome V	2015-04-13
PMN K141991 | KNS Olympus Vietnam Company Limited [Olympus Medical Systems Corporation]	Single Use Sphincterotome V(Distal Wireguided)	2015-04-13
PMN K141991 | KNS Olympus Vietnam Company Limited [Olympus Medical Systems Corporation]	Single Use Sphincterotome V (Distal Wireguided)	2015-04-13
PMN K141991 | KNS Olympus Vietnam Company Limited [Olympus Medical Systems Corporation]	Single Use Preloaded Sphincterotome V(Distal Wireguided)	2015-04-13
PMN K141991 | KNS Olympus Vietnam Company Limited [Olympus Medical Systems Corporation]	Single Use Preloaded Sphincterotome V (Distal Wireguided)	2015-04-13
PMN K091495 | LQR Olympus Vietnam Company Limited [Olympus Medical Systems Corporation]	Single Use 3-Lumen Extraction Balloon V	2009-09-10
PMN K091495 | FGE Olympus Vietnam Company Limited [Olympus Medical Systems Corporation]	Single Use 3-Lumen Extraction Balloon V	2009-09-10
PMN K984358 | FDS Olympus Vietnam Company Limited [Olympus Medical Systems Corporation]	Distal Attachment	2008-06-17
PMN K984358 | FDS Olympus Vietnam Company Limited [Olympus Medical Systems Corporation]	DISTAL HOOD	2008-06-17
PMN K984358 | FDS Olympus Vietnam Company Limited [Olympus Medical Systems Corporation]	DISPOSABLE EMR KIT	2008-06-17
PMN K984358 | FDS Olympus Vietnam Company Limited [Olympus Medical Systems Corporation]	DISPOSABLE DISTAL ATTACHMENT	2008-06-17
PMN K980465 | FDT Olympus Vietnam Company Limited [Olympus Medical Systems Corporation]	SINGLE USE LIGATING DEVICE	2008-06-17
PMN K950636 | EOQ Olympus Vietnam Company Limited [Olympus Medical Systems Corporation]	DISPOSABLE BIOPSY FORCEPS	2008-06-17
PMN K050503 | FCG Olympus Vietnam Company Limited [Olympus Medical Systems Corporation]	Single use adaptor biopsy valve	2008-06-16
PMN K050503 | FCG Olympus Vietnam Company Limited [Olympus Medical Systems Corporation]	Single Use Aspiration Needle	2008-06-16
MNL Olympus Vietnam Company Limited [Olympus Medical Systems Corporation]	Single Use Soft Brush	2008-03-03
MNL Olympus Vietnam Company Limited [Olympus Medical Systems Corporation]	Single Use Single-ended Cleaning Brush	2008-03-03
MNL Olympus Vietnam Company Limited [Olympus Medical Systems Corporation]	Single Use Single-ended Cleaning Brush BW-403B	2008-03-03
MNL Olympus Vietnam Company Limited [Olympus Medical Systems Corporation]	Single Use Combination Cleaning Brush	2008-03-03
MNL Olympus Vietnam Company Limited [Olympus Medical Systems Corporation]	Single Use Channel-Opening Cleaning Brush	2008-03-03
MNL Olympus Vietnam Company Limited [Olympus Medical Systems Corporation]	SPLINTING TUBE CLEANING BRUSH	2008-03-03
MNL Olympus Vietnam Company Limited [Olympus Medical Systems Corporation]	Channel-opening cleaning brush	2008-03-03
MNL Olympus Vietnam Company Limited [Olympus Medical Systems Corporation]	Channel Cleaning Brush	2008-03-03
MNL Olympus Vietnam Company Limited [Olympus Medical Systems Corporation]	CHANNEL CLEANING WIRE	2008-03-03
FCL Olympus Vietnam Company Limited [Olympus Medical Systems Corporation]	Single Use Biopsy Forceps	2008-03-03
PMN K951445 | KGE Olympus Vietnam Company Limited [Olympus Medical Systems Corporation]	DISPOSABLE HOT BIOPSY FORCEPS	2007-11-30
PMN K955065 | FCL Olympus Vietnam Company Limited [Olympus Medical Systems Corporation]	SURGICAL SCISSORS	2006-12-01
PMN K955065 | FCL Olympus Vietnam Company Limited [Olympus Medical Systems Corporation]	LOOP CUTTER	2006-12-01
PMN K955065 | FCL Olympus Vietnam Company Limited [Olympus Medical Systems Corporation]	DISPOSABLE BIOPSY FORCEPS	2006-12-01
PMN K955065 | FCL Olympus Vietnam Company Limited [Olympus Medical Systems Corporation]	BIOPSY FORCEPS	2006-12-01
PMN K950166 | KNS Olympus Vietnam Company Limited [Olympus Medical Systems Corporation]	Single Use 3-Lumen Sphincterotome V	2006-12-01
PMN K950166 | KNS Olympus Vietnam Company Limited [Olympus Medical Systems Corporation]	Single Use 2-Lumen Sphincterotome V	2006-12-01
PMN K950166 | KNS Olympus Vietnam Company Limited [Olympus Medical Systems Corporation]	DISPOSABLE TRIPLE LUMEN SPHINCTEROTOME	2006-12-01
PMN K950166 | KNS Olympus Vietnam Company Limited [Olympus Medical Systems Corporation]	DISPOSABLE PAPILLOTOMY KNIFE	2006-12-01
PMN K013066 | MND Olympus Vietnam Company Limited [Olympus Medical Systems Corporation]	Super Short Clip	2006-12-01
PMN K013066 | MND Olympus Vietnam Company Limited [Olympus Medical Systems Corporation]	Single Use Rotatable Clip Fixing Device	2006-12-01
PMN K013066 | MND Olympus Vietnam Company Limited [Olympus Medical Systems Corporation]	Short Clip	2006-12-01
PMN K013066 | MND Olympus Vietnam Company Limited [Olympus Medical Systems Corporation]	Rotatable Clip Fixing Device	2006-12-01
PMN K013066 | MND Olympus Vietnam Company Limited [Olympus Medical Systems Corporation]	Long Clip	2006-12-01
PMN K013066 | MND Olympus Vietnam Company Limited [Olympus Medical Systems Corporation]	Colored Short Clip	2006-12-01
PMN K013066 | MND Olympus Vietnam Company Limited [Olympus Medical Systems Corporation]	Clip	2006-12-01
PMN K955650 | FDI Olympus Vietnam Company Limited [Olympus Medical Systems Corporation]	Wire Leader	2002-02-20
PMN K955650 | FDI Olympus Vietnam Company Limited [Olympus Medical Systems Corporation]	Snare Wire	2002-02-20
PMN K955650 | FDI Olympus Vietnam Company Limited [Olympus Medical Systems Corporation]	Snare Tube	2002-02-20
PMN K955650 | FDI Olympus Vietnam Company Limited [Olympus Medical Systems Corporation]	SD HANDLE	2002-02-20
PMN K955650 | FDI Olympus Vietnam Company Limited [Olympus Medical Systems Corporation]	ELECTROSURGICAL SNARE	2002-02-20
PMN K955650 | FDI Olympus Vietnam Company Limited [Olympus Medical Systems Corporation]	DISPOSABLE ELECTROSURGICAL SNARE	2002-02-20
PMN K955650 | FAS Olympus Vietnam Company Limited [Olympus Medical Systems Corporation]	Wire Leader	2002-02-20
PMN K955650 | FAS Olympus Vietnam Company Limited [Olympus Medical Systems Corporation]	Snare Wire	2002-02-20
PMN K955650 | FAS Olympus Vietnam Company Limited [Olympus Medical Systems Corporation]	Snare Tube	2002-02-20
PMN K955650 | FAS Olympus Vietnam Company Limited [Olympus Medical Systems Corporation]	SD HANDLE	2002-02-20
PMN K955650 | FAS Olympus Vietnam Company Limited [Olympus Medical Systems Corporation]	ELECTROSURGICAL SNARE	2002-02-20
PMN K955650 | FAS Olympus Vietnam Company Limited [Olympus Medical Systems Corporation]	DISPOSABLE ELECTROSURGICAL SNARE	2002-02-20

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020060312573	Vung Tau,Vietnam -> New York/Newark Area, Newark, New Jersey	SINGLE USE COMBINATION CLEANING BRUSH	1920 BOX
2020052812538	Vung Tau,Vietnam -> New York/Newark Area, Newark, New Jersey	SINGLE USE COMBINATION CLEANING BRUSH	3840 BOX
2020052812538	Vung Tau,Vietnam -> New York/Newark Area, Newark, New Jersey	SINGLE USE COMBINATION CLEANING BRUSH	3840 BOX
2020052813825	Vung Tau,Vietnam -> New York/Newark Area, Newark, New Jersey	DIGITAL AUDIO PLAYER AND ACCESSORIES	1320 CTN
2020052010846	Vung Tau,Vietnam -> New York/Newark Area, Newark, New Jersey	SINGLE USE COMBINATION CLEANING BRUSH	1920 BOX
2020051312708	Vung Tau,Vietnam -> New York/Newark Area, Newark, New Jersey	SINGLE USE COMBINATION CLEANING BRUSH	3840 BOX
2020051312708	Vung Tau,Vietnam -> New York/Newark Area, Newark, New Jersey	SINGLE USE COMBINATION CLEANING BRUSH	3840 BOX
2020051312692	Vung Tau,Vietnam -> New York/Newark Area, Newark, New Jersey	DIGITAL AUDIO PLAYER AND ACCESSORIES	4296 CTN
202005053957	Vung Tau,Vietnam -> New York/Newark Area, Newark, New Jersey	SINGLE USE COMBINATION CLEANING BRUSH	3840 BOX
202005053957	Vung Tau,Vietnam -> New York/Newark Area, Newark, New Jersey	SINGLE USE COMBINATION CLEANING BRUSH	3840 BOX
2020042510577	Vung Tau,Vietnam -> New York/Newark Area, Newark, New Jersey	SINGLE USE COMBINATION CLEANING BRUSH	3840 BOX
2020042510577	Vung Tau,Vietnam -> New York/Newark Area, Newark, New Jersey	SINGLE USE COMBINATION CLEANING BRUSH	3840 BOX