Olympus Corp Of Americas

FDA Filings

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

FDA Registration(s)

• Registration Number: 2951238
• FEI Number: 1000635022
• Name: Olympus Corporation of the Americas
• Owner & Operator: Olympus Corporation of the Americas
• Contact Address: 3500 Corporate Parkway --; Center Valley PA 18034 US
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2400 RINGWOOD AVE. ; SAN JOSE, CA 95131 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

• Registration Number: 2429304
• FEI Number: 2429304
• Name: OLYMPUS Corporation of the Americas
• Owner & Operator: Olympus Corporation
• Contact Address: SHINJUKU MONOLITH 2-3-1 NISHI-SHINJUKU; SHINJUKU-KU, TOKYO JP-NOTA 163-0914 JP
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 3500 CORPORATE PKWY. ; CENTER VALLEY, PA 18034 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
PMN K142680 | NEZ OLYMPUS Corporation of the Americas [Olympus Corporation]	Endocapsule	2015-06-04
PMN K142525 | HIN OLYMPUS Corporation of the Americas [Olympus Corporation]	PK Lap Loop	2015-06-04
PMN K141225 | GEI OLYMPUS Corporation of the Americas [Olympus Corporation]	ESG-400	2015-06-04
PMN K140624 | GEI OLYMPUS Corporation of the Americas [Olympus Corporation]	Hicura Hand Instruments	2015-06-04
PMN K132703 | LFL OLYMPUS Corporation of the Americas [Olympus Corporation]	Thunderbeat	2015-06-04
PMN K132703 | GEI OLYMPUS Corporation of the Americas [Olympus Corporation]	Thunderbeat	2015-06-04
PMN K123601 | PKL OLYMPUS Corporation of the Americas [Olympus Corporation]	Quick Clip Pro	2015-06-04
PMN K123319 | KNS OLYMPUS Corporation of the Americas [Olympus Corporation]	Bicoag Hemostasis Probe	2015-06-04
PMN K122505 | KNS OLYMPUS Corporation of the Americas [Olympus Corporation]	Preloaded Sphincterotome	2015-06-04
PMN K122180 | OSV OLYMPUS Corporation of the Americas [Olympus Corporation]	High Flow Insufflation Unit	2015-06-04
PMN K122180 | HIF OLYMPUS Corporation of the Americas [Olympus Corporation]	High Flow Insufflation Unit	2015-06-04
PMN K122180 | FCX OLYMPUS Corporation of the Americas [Olympus Corporation]	High Flow Insufflation Unit	2015-06-04
PMN K111202 | LFL OLYMPUS Corporation of the Americas [Olympus Corporation]	Thunderbeat	2015-06-04
PMN K111202 | KNS OLYMPUS Corporation of the Americas [Olympus Corporation]	Thunderbeat	2015-06-04
PMN K111202 | GEI OLYMPUS Corporation of the Americas [Olympus Corporation]	Thunderbeat	2015-06-04
PMN K103478 | FGE OLYMPUS Corporation of the Americas [Olympus Corporation]	Single Use Biliary Drainage Stent	2015-06-04
PMN K103032 | GEI OLYMPUS Corporation of the Americas [Olympus Corporation]	ESG-400	2015-06-04
PMN K102781 | GEI OLYMPUS Corporation of the Americas [Olympus Corporation]	HH Resection Electrodes and Button Electrode for Plasma Vaporation	2015-06-04
PMN K102781 | FAS OLYMPUS Corporation of the Americas [Olympus Corporation]	HH Resection Electrodes and Button Electrode for Plasma Vaporation	2015-06-04
PMN K103264 | FEB OLYMPUS Corporation of the Americas [Olympus Corporation]	OER-Pro	2015-03-11
PMN K093106 | FEB OLYMPUS Corporation of the Americas [Olympus Corporation]	OER-Pro	2015-03-11
PMN K133538 OLYMPUS CORPORATION OF THE AMERICAS	VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE VA2, VISERA CYSTO-NE	2014-08-07
PMN K992222 | ETD Olympus Corporation of the Americas	typmanostomy tube	2014-01-09
PMN K992126 | GCX Olympus Corporation of the Americas	Surgiflex Wave suction irrigation system	2014-01-09
PMN K990628 | KNS Olympus Corporation of the Americas	Endourology system	2014-01-09
PMN K990628 | FDS Olympus Corporation of the Americas	Endourology system	2014-01-09
PMN K982289 | KNS Olympus Corporation of the Americas	Heat Probe unit	2014-01-09
PMN K981751 | EOB Olympus Corporation of the Americas	Nasopharyngoscope	2014-01-09
PMN K980492 | FFK Olympus Corporation of the Americas	AEH-3 ELECTROHYDRAULIC LITHOTRIPTER	2014-01-09
PMN K974311 | KHJ Olympus Corporation of the Americas	VOCOM implant	2014-01-09
PMN K973286 | ERL Olympus Corporation of the Americas	ENT Irrigating Pump	2014-01-09
PMN K973286 | EOB Olympus Corporation of the Americas	ENT Irrigating Pump	2014-01-09
PMN K971328 | FFE Olympus Corporation of the Americas	CD coagulation electrode	2014-01-09
PMN K964334 | HET Olympus Corporation of the Americas	EXPANDACELL ANTI-FOG INSTRUMENT WIPE	2014-01-09
PMN K964334 | GCJ Olympus Corporation of the Americas	EXPANDACELL ANTI-FOG INSTRUMENT WIPE	2014-01-09
PMN K963033 | EOQ Olympus Corporation of the Americas	Bronchoscope	2014-01-09
PMN K962564 | ETB Olympus Corporation of the Americas	Ossicular prosthesis	2014-01-09
PMN K962564 | ETA Olympus Corporation of the Americas	Ossicular prosthesis	2014-01-09
PMN K954451 | FET Olympus Corporation of the Americas	Endoscopy system	2014-01-09
PMN K953162 | HIF Olympus Corporation of the Americas	Insufflator	2014-01-09
PMN K953096 | ERL Olympus Corporation of the Americas	Shaver System	2014-01-09
PMN K953096 | EQJ Olympus Corporation of the Americas	Shaver System	2014-01-09
PMN K952892 | ITX Olympus Corporation of the Americas	Endoscopic Utrasound system	2014-01-09
PMN K951445 | KGE Olympus Corporation of the Americas	Biopsy Forceps	2014-01-09
PMN K950984 | ETB Olympus Corporation of the Americas	Hapes Incus Stapes	2014-01-09
PMN K944912 | FGE Olympus Corporation of the Americas	NBD tubes	2014-01-09
PMN K941743 | HIG Olympus Corporation of the Americas	Insufflator	2014-01-09
PMN K940133 | LRD Olympus Corporation of the Americas	EXPANDACELL EAR PACK	2014-01-09
PMN K936048 | FST Olympus Corporation of the Americas	Lightwear system	2014-01-09
PMN K936048 | FSQ Olympus Corporation of the Americas	Lightwear system	2014-01-09
PMN K935235 | GCM Olympus Corporation of the Americas	Rigid endoscope	2014-01-09
PMN K934733 | ETN Olympus Corporation of the Americas	Stimulating Surgical Instruments	2014-01-09
PMN K934432 | EWA Olympus Corporation of the Americas	Otoview endoscopy system	2014-01-09
PMN K921433 | ETC Olympus Corporation of the Americas	Attic Defect Plate	2014-01-09
PMN K914496 | FBK Olympus Corporation of the Americas	SCLEROTHERAPY NEEDLE	2014-01-09
PMN K912120 | FBN Olympus Corporation of the Americas	Endoscope	2014-01-09
PMN K911904 | GEI Olympus Corporation of the Americas	UES-10 and PSD-10	2014-01-09
PMN K904797 | FBO Olympus Corporation of the Americas	cystourethroscope	2014-01-09
PMN K903529 | LQC Olympus Corporation of the Americas	Lithotripsy system	2014-01-09
PMN K902737 | FDX Olympus Corporation of the Americas	Cytology Brush	2014-01-09
PMN K902734 | FGE Olympus Corporation of the Americas	PR cannulas	2014-01-09
PMN K893491 | FST Olympus Corporation of the Americas	M2-150/I-150/M2-150T/M3-150/M2-150,300-300	2014-01-09
PMN K891451 | HIH Olympus Corporation of the Americas	Hysteroscope	2014-01-09
PMN K874467 | FPA Olympus Corporation of the Americas	Lithotripsy system	2014-01-09
PMN K873367 | FEO Olympus Corporation of the Americas	Lithotripsy system	2014-01-09
PMN K864443 | ETA Olympus Corporation of the Americas	EGG Top Porp and EGG Top Torp	2014-01-09
PMN K852980 | HEX Olympus Corporation of the Americas	Endoscope	2014-01-09
PMN K850978 | CAL Olympus Corporation of the Americas	Laryngoscope	2014-01-09
PMN K781574 | FZE Olympus Corporation of the Americas	PLASTI-PORE SEPTAL BUTTON	2014-01-09
PMN K780586 | GDW Olympus Corporation of the Americas	Microclip	2014-01-09
PMN K760435 | ETB Olympus Corporation of the Americas	Otology Implant	2014-01-09
PMN K063786 | FCX Olympus Corporation of the Americas	Insufflator	2014-01-09
PMN K051551 | KNT Olympus Corporation of the Americas	SIF endoscope	2014-01-09
PMN K042516 | NEA Olympus Corporation of the Americas	OTOMIMIX	2014-01-09
PMN K041285 | GEI Olympus Corporation of the Americas	G3 electrosurgical system	2014-01-09
PMN K031078 | GEI Olympus Corporation of the Americas	Everest Bipolar electrosurgical system and accessories	2014-01-09
PMN K030935 | HHK Olympus Corporation of the Americas	Berkeley Curretage System	2014-01-09
PMN K030935 | HHI Olympus Corporation of the Americas	Berkeley Curretage System	2014-01-09
PMN K030343 | HAW Olympus Corporation of the Americas	Diego Dissector Handpiece	2014-01-09
PMN K021595 | ETN Olympus Corporation of the Americas	Nerve Stimulator	2014-01-09
PMN K021166 | FDC Olympus Corporation of the Americas	Bipolar resectoscope	2014-01-09
PMN K021166 | FBO Olympus Corporation of the Americas	Bipolar resectoscope	2014-01-09
PMN K020778 | GEI Olympus Corporation of the Americas	Somnoplasty electrosurgical system and accessories	2014-01-09
PMN K020594 | ERL Olympus Corporation of the Americas	ENT Surgical Drill	2014-01-09
PMN K013165 | GCJ Olympus Corporation of the Americas	laparoscopes	2014-01-09
PMN K012073 | EOQ Olympus Corporation of the Americas	Bronchoscope	2014-01-09
PMN K012018 | GEI Olympus Corporation of the Americas	BICAP COAG BIPOLAR LAPAROSCOPY PROBE	2014-01-09
PMN K002749 | JAB Olympus Corporation of the Americas	Endocope contour detection device	2014-01-09
PMN K002749 | FDF Olympus Corporation of the Americas	Endocope contour detection device	2014-01-09
PMN K002702 | KKX Olympus Corporation of the Americas	Surgical drape	2014-01-09
PMN K001241 | FDF Olympus Corporation of the Americas	Endoscope	2014-01-09
PMN K000533 | MIX Olympus Corporation of the Americas	Vocom implant	2014-01-09
PMN K000256 | ETB Olympus Corporation of the Americas	Cap Porp and Cap Torp	2014-01-09
PMN K000256 | ETA Olympus Corporation of the Americas	Cap Porp and Cap Torp	2014-01-09
PMN DEN020003 | NIX Olympus Corporation of the Americas	RetroX hearing aid	2014-01-09
PMN K001203 | ITX Olympus Corporation of the Americas	ultrasonic probe	2013-02-26
LMD OLYMPUS Corporation of the Americas [Olympus Corporation]	ImageManager and EndoWorks software	2009-07-14
PMN K952888 | LMB OLYMPUS Corporation of the Americas [Olympus Corporation]	ImageManager and EndoWorks software	2009-04-14
PMN K934889 | LMB OLYMPUS Corporation of the Americas [Olympus Corporation]	Image Manager and Endoworks software	2009-04-14
PMN K934889 | LMB OLYMPUS Corporation of the Americas [Olympus Corporation]	EndoWorks	2009-04-14
PMN K934889 | LLZ OLYMPUS Corporation of the Americas [Olympus Corporation]	Image Manager and Endoworks software	2009-04-14
PMN K934889 | LLZ OLYMPUS Corporation of the Americas [Olympus Corporation]	EndoWorks	2009-04-14
PMN K934888 | LMB OLYMPUS Corporation of the Americas [Olympus Corporation]	ImageManager and Endoworks software	2009-04-14

Related Finance Registrations

NCAGE Code	8DP85	OLYMPUS CORPORATION OF THE AMERICAS
CAGE Code	8DP85	OLYMPUS CORPORATION OF THE AMERICAS

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
20200929101930	London,United Kingdom -> New York, New York	MEDICAL EQUIPMENT	49 CTN
20200929101930	London,United Kingdom -> New York, New York	MEDICAL EQUIPMENT	49 CTN
2020092555429	Tokyo ,Japan -> Los Angeles, California	ENDOSCOPIC EQUIPMENT (3923.50)	142 CTN
2020092295999	London,United Kingdom -> New York, New York	MEDICAL EQUIPMENT	49 CTN
2020092295999	London,United Kingdom -> New York, New York	MEDICAL EQUIPMENT	49 CTN
2020091930324	Tokyo ,Japan -> Los Angeles, California	ENDOSCOPIC EQUIPMENT (8421.29)	165 CTN
2020091966742	Tokyo ,Japan -> Los Angeles, California	ENDOSCOPIC EQUIPMENT (3923.50)	238 CTN
2020091968490	London,United Kingdom -> New York, New York	MEDICAL EQUIPMENT	231 CTN
2020091968490	London,United Kingdom -> New York, New York	MEDICAL EQUIPMENT	231 CTN
2020091823631	Tokyo ,Japan -> Los Angeles, California	ENDOSCOPIC EQUIPMENT (8421.29)	165 CTN
2020091858909	Tokyo ,Japan -> Los Angeles, California	ENDOSCOPIC EQUIPMENT (3923.50)	238 CTN