Hakko Co L T D

FDA Filings

This page includes the latest FDA filings for Hakko 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: 9611481
• FEI Number: 3002807220
• Name: Shelly Ast
• Owner & Operator: HAKKO CO., LTD.
• Contact Address: NO. 3055 O-AZA TOGURAONSEN CHIKUMA-SHI; NAGANO JP-NOTA 389-0807 JP
• US Agent:
  • Shelly Ast
  • Havel's Inc.
  • 513 5271273
  • SAst@havels.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 3726 Lonsdale St. ; Cincinnati, OH 45227 US
• Establishment Type:
  • Manufacture Medical Device
  • Sterilize Medical Device for Another Party (Contract Sterilizer)

FDA Filings

Device Company	Device	Date
GUDID 14526737171231 HAKKO CO.,LTD.	EchoStim MSK	2022-10-10
GUDID 14526737171224 HAKKO CO.,LTD.	EchoStim MSK	2022-10-10
GUDID 14526737171217 HAKKO CO.,LTD.	EchoStim MSK	2022-10-10
GUDID 14526737171200 HAKKO CO.,LTD.	EchoStim MSK	2022-10-10
GUDID 14526737171194 HAKKO CO.,LTD.	EchoStim MSK	2022-10-10
GUDID 14526737171170 HAKKO CO.,LTD.	EchoStim MSK	2022-10-10
GUDID 14526737171156 HAKKO CO.,LTD.	EchoStim EB	2022-10-10
GUDID 14526737171132 HAKKO CO.,LTD.	EchoStim EB	2022-10-10
GUDID 04526737171180 HAKKO CO.,LTD.	EchoStim MSK	2022-10-10
GUDID 04526737171166 HAKKO CO.,LTD.	EchoStim EB	2022-10-10
GUDID 04526737171142 HAKKO CO.,LTD.	EchoStim EB	2022-10-10
GUDID 14526737171125 HAKKO CO.,LTD.	EchoStim	2019-07-22
GUDID 14526737171118 HAKKO CO.,LTD.	EchoStim	2019-07-22
GUDID 14526737170647 HAKKO CO.,LTD.	EchoStim	2019-07-22
GUDID 14526737170630 HAKKO CO.,LTD.	EchoStim	2019-07-22
GUDID 14526737170623 HAKKO CO.,LTD.	EchoStim	2019-07-22
GUDID 14526737170616 HAKKO CO.,LTD.	EchoStim	2019-07-22
GUDID 14526737170388 HAKKO CO.,LTD.	Curved Tip Needle	2018-07-06
GUDID 14526737170371 HAKKO CO.,LTD.	Curved Tip Needle	2018-07-06
GUDID 14526737170364 HAKKO CO.,LTD.	Curved Tip Needle	2018-07-06
GUDID 14526737170357 HAKKO CO.,LTD.	Curved Tip Needle	2018-07-06
GUDID 14526737170340 HAKKO CO.,LTD.	Curved Tip Needle	2018-07-06
GUDID 14526737170333 HAKKO CO.,LTD.	Curved Tip Needle	2018-07-06
GUDID 14526737170173 HAKKO CO.,LTD.	Spinal Needle	2018-07-06
GUDID 14526737120413 HAKKO CO.,LTD.	PTC Spinal Needle	2018-07-06
GUDID 14526737120086 HAKKO CO.,LTD.	PTC Spinal Needle	2018-07-06
GUDID 14526737120062 HAKKO CO.,LTD.	PTC Spinal Needle	2018-07-06
GUDID 14526737120055 HAKKO CO.,LTD.	Sonopsy-C1	2018-07-06
GUDID 14526737120048 HAKKO CO.,LTD.	Sonopsy-C1	2018-07-06
GUDID 14526737120017 HAKKO CO.,LTD.	BIOSUC-C7	2018-07-06
GUDID 04526737170404 HAKKO CO.,LTD.	Spinal Needle	2018-07-06
GUDID 04526737170398 HAKKO CO.,LTD.	Spinal Needle	2018-07-06
GUDID 04526737170329 HAKKO CO.,LTD.	Spinal Needle	2018-07-06
GUDID 04526737170312 HAKKO CO.,LTD.	Spinal Needle	2018-07-06
GUDID 04526737170305 HAKKO CO.,LTD.	Spinal Needle	2018-07-06
GUDID 04526737170299 HAKKO CO.,LTD.	Spinal Needle	2018-07-06
GUDID 04526737170282 HAKKO CO.,LTD.	Spinal Needle	2018-07-06
GUDID 04526737170275 HAKKO CO.,LTD.	Spinal Needle	2018-07-06
GUDID 04526737170268 HAKKO CO.,LTD.	Spinal Needle	2018-07-06
GUDID 04526737170251 HAKKO CO.,LTD.	Spinal Needle	2018-07-06
GUDID 04526737170244 HAKKO CO.,LTD.	Spinal Needle	2018-07-06
GUDID 04526737170237 HAKKO CO.,LTD.	Spinal Needle	2018-07-06
GUDID 04526737170220 HAKKO CO.,LTD.	Spinal Needle	2018-07-06
GUDID 04526737170213 HAKKO CO.,LTD.	Spinal Needle	2018-07-06
GUDID 04526737170206 HAKKO CO.,LTD.	Spinal Needle	2018-07-06
GUDID 04526737170190 HAKKO CO.,LTD.	Spinal Needle	2018-07-06
GUDID 04526737170183 HAKKO CO.,LTD.	Spinal Needle	2018-07-06
GUDID 04526737170169 HAKKO CO.,LTD.	Spinal Needle	2018-07-06
GUDID 04526737170152 HAKKO CO.,LTD.	Spinal Needle	2018-07-06
GUDID 04526737170145 HAKKO CO.,LTD.	Spinal Needle	2018-07-06
GUDID 04526737170138 HAKKO CO.,LTD.	Spinal Needle	2018-07-06
GUDID 04526737170121 HAKKO CO.,LTD.	Spinal Needle	2018-07-06
GUDID 04526737170114 HAKKO CO.,LTD.	Spinal Needle	2018-07-06
GUDID 04526737170107 HAKKO CO.,LTD.	Spinal Needle	2018-07-06
GUDID 04526737170091 HAKKO CO.,LTD.	Spinal Needle	2018-07-06
GUDID 04526737170084 HAKKO CO.,LTD.	Spinal Needle	2018-07-06
GUDID 04526737170077 HAKKO CO.,LTD.	Spinal Needle	2018-07-06
GUDID 04526737170060 HAKKO CO.,LTD.	Spinal Needle	2018-07-06
GUDID 04526737170053 HAKKO CO.,LTD.	Spinal Needle	2018-07-06
GUDID 04526737170046 HAKKO CO.,LTD.	Spinal Needle	2018-07-06
GUDID 04526737170039 HAKKO CO.,LTD.	Spinal Needle	2018-07-06
GUDID 04526737170022 HAKKO CO.,LTD.	Spinal Needle	2018-07-06
GUDID 04526737170015 HAKKO CO.,LTD.	Spinal Needle	2018-07-06
GUDID 04526737170008 HAKKO CO.,LTD.	Spinal Needle	2018-07-06
GUDID 04526737120409 HAKKO CO.,LTD.	PTC Spinal Needle	2018-07-06
GUDID 04526737120393 HAKKO CO.,LTD.	PTC Spinal Needle	2018-07-06
GUDID 04526737120386 HAKKO CO.,LTD.	PTC Spinal Needle	2018-07-06
GUDID 04526737120379 HAKKO CO.,LTD.	PTC Spinal Needle	2018-07-06
GUDID 04526737120362 HAKKO CO.,LTD.	Chiba-Type Spinal Needle	2018-07-06
GUDID 04526737120355 HAKKO CO.,LTD.	Chiba-Type Spinal Needle	2018-07-06
GUDID 04526737120348 HAKKO CO.,LTD.	Chiba-Type Spinal Needle	2018-07-06
GUDID 04526737120331 HAKKO CO.,LTD.	Chiba-Type Spinal Needle	2018-07-06
GUDID 04526737120324 HAKKO CO.,LTD.	Chiba-Type Spinal Needle	2018-07-06
GUDID 04526737120317 HAKKO CO.,LTD.	Chiba-Type Spinal Needle	2018-07-06
GUDID 04526737120300 HAKKO CO.,LTD.	Chiba-Type Spinal Needle	2018-07-06
GUDID 04526737120294 HAKKO CO.,LTD.	Chiba-Type Spinal Needle	2018-07-06
GUDID 04526737120287 HAKKO CO.,LTD.	Chiba-Type Spinal Needle	2018-07-06
GUDID 04526737120270 HAKKO CO.,LTD.	Chiba-Type Spinal Needle	2018-07-06
GUDID 04526737120263 HAKKO CO.,LTD.	Chiba-Type Spinal Needle	2018-07-06
GUDID 04526737120256 HAKKO CO.,LTD.	Chiba-Type Spinal Needle	2018-07-06
GUDID 04526737120249 HAKKO CO.,LTD.	Chiba-Type Spinal Needle	2018-07-06
GUDID 04526737120232 HAKKO CO.,LTD.	Chiba-Type Spinal Needle	2018-07-06
GUDID 04526737120225 HAKKO CO.,LTD.	Chiba-Type Spinal Needle	2018-07-06
GUDID 04526737120218 HAKKO CO.,LTD.	PTC Spinal Needle	2018-07-06
GUDID 04526737120201 HAKKO CO.,LTD.	PTC Spinal Needle	2018-07-06
GUDID 04526737120195 HAKKO CO.,LTD.	PTC Spinal Needle	2018-07-06
GUDID 04526737120188 HAKKO CO.,LTD.	PTC Spinal Needle	2018-07-06
GUDID 04526737120171 HAKKO CO.,LTD.	PTC Spinal Needle	2018-07-06
GUDID 04526737120164 HAKKO CO.,LTD.	PTC Spinal Needle	2018-07-06
GUDID 04526737120157 HAKKO CO.,LTD.	PTC Spinal Needle	2018-07-06
GUDID 04526737120140 HAKKO CO.,LTD.	PTC Spinal Needle	2018-07-06
GUDID 04526737120133 HAKKO CO.,LTD.	PTC Spinal Needle	2018-07-06
GUDID 04526737120126 HAKKO CO.,LTD.	PTC Spinal Needle	2018-07-06
GUDID 04526737120119 HAKKO CO.,LTD.	PTC Spinal Needle	2018-07-06
GUDID 04526737120102 HAKKO CO.,LTD.	PTC Spinal Needle	2018-07-06
GUDID 04526737120096 HAKKO CO.,LTD.	PTC Spinal Needle	2018-07-06
GUDID 04526737120072 HAKKO CO.,LTD.	PTC Spinal Needle	2018-07-06
GUDID 04526737120034 HAKKO CO.,LTD.	BIOSUC-C7	2018-07-06
GUDID 04526737120027 HAKKO CO.,LTD.	BIOSUC-C7	2018-07-06
GUDID 04526737120003 HAKKO CO.,LTD.	BIOSUC-C7	2018-07-06
PMN K860126 | BXN Shelly Ast [HAKKO CO., LTD.]	Stimuplex (DIG,RC, A)	2012-12-14
PMN K063380 | BSP Shelly Ast [HAKKO CO., LTD.]	Echostim Facet Tip	2012-02-10
PMN K961152 | BSP Shelly Ast [HAKKO CO., LTD.]	Tuohy Epidural Needle	2007-11-13
PMN K961151 | BSP Shelly Ast [HAKKO CO., LTD.]	Hakko Spinal Needle	2007-11-13
PMN K013109 | FCG Shelly Ast [HAKKO CO., LTD.]	Sonopsy Needle	2007-11-13
PMN K013108 | KNW Shelly Ast [HAKKO CO., LTD.]	Biosuc Fine Aspiration	2007-11-13
GDF Shelly Ast [HAKKO CO., LTD.]	ACCUTARG	2001-11-13

Similar & Related FDA Registered Companies

• HAKKO MEDICAL CO., LTD.
• HAKKO SHOJI CO., LTD.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020090477732	Tokyo ,Japan -> Los Angeles, California	MEDICAL INSTRUMENTS HS CODE 9018.32	102 CTN
2020050145629	Tokyo ,Japan -> Los Angeles, California	MEDICAL INSTRUMENTS HS 9018.32	10 CTN
2020040651579	Tokyo ,Japan -> Los Angeles, California	MEDICAL INSTRUMENTS HS 9018.32	16 CTN
2020022734748	Tokyo ,Japan -> Los Angeles, California	MEDICAL INSTRUMENTS	12 CTN
2020021545359	Tokyo ,Japan -> Los Angeles, California	HS CODE 901832 901831 MEDICAL INSTRUMENTS	82 CTN
2020010375692	Tokyo ,Japan -> Los Angeles, California	MEIDCAL INSTRUMENTS HS 9018.32 9018.31	43 CTN
2019120643335	Tokyo ,Japan -> Los Angeles, California	MEDICAL INSTRUMENTS HS CODE 901832 / 901831	58 CTN
2019111541143	Tokyo ,Japan -> Los Angeles, California	MEDICAL INSTRUMENTS HS 9018.32, 9018.31	65 CTN