Medone Surgical Inc

FDA Filings

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

FDA Registration(s)

• Registration Number: 1064371
• FEI Number: 3002865793
• Name: MEDONE SURGICAL, INC.
• Owner & Operator: MEDONE SURGICAL, INC.
• Contact Address: 670 TALLEVAST ROAD --; Sarasota FL 34243 US
• Official Correspondent:
  • BRUCE - BECKSTEIN
  • x-941-3593129-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 670 TALLEVAST ROAD ; SARASOTA, FL 34243 US
• Establishment Type:
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device
  • Repack or Relabel Medical Device

FDA Filings

Device Company	Device	Date
GUDID 00811313013317 MEDONE SURGICAL INC	MedOne 3331	2025-09-03
GUDID 00811313013300 MEDONE SURGICAL INC	MedOne 3330	2025-09-03
GUDID 00811313013164 MEDONE SURGICAL INC	MedOne 3316	2025-09-02
GUDID 00811313013157 MEDONE SURGICAL INC	MedOne 3315	2023-06-09
GUDID 00811313013195 MEDONE SURGICAL INC	MedOne 3319	2022-09-01
GUDID 00811313013089 MEDONE SURGICAL INC	MedOne 3308	2022-01-28
GUDID 00811313013072 MEDONE SURGICAL INC	MedOne 3307	2022-01-28
GUDID 00811313013065 MEDONE SURGICAL INC	MedOne 3306	2022-01-17
GUDID 00811313013058 MEDONE SURGICAL INC	MedOne 3305	2022-01-17
PMN K203264 MedOne Surgical, Inc.	MicroDose Injector	2021-04-26
GUDID 00811313013027 MEDONE SURGICAL INC	MedOne 3302	2021-01-20
GUDID 10811313012638 MEDONE SURGICAL INC	MedOne 3263	2020-05-18
GUDID 10811313012614 MEDONE SURGICAL INC	MedOne 3261	2020-05-18
GUDID 00811313015083 MEDONE SURGICAL INC	MedOne 3508	2020-05-18
GUDID 00811313015076 MEDONE SURGICAL INC	MedOne 3507	2020-05-18
GUDID 00811313015069 MEDONE SURGICAL INC	MedOne 3506	2020-05-18
GUDID 00811313014277 MEDONE SURGICAL INC	MedOne 3427	2020-05-18
GUDID 00811313014253 MEDONE SURGICAL INC	MedOne 3425	2020-05-18
GUDID 00811313014239 MEDONE SURGICAL INC	MedOne 3423	2020-05-18
GUDID 00811313013119 MEDONE SURGICAL INC	MedOne 3311	2020-05-18
GUDID 00811313013010 MEDONE SURGICAL INC	MedOne 3301	2020-05-18
GUDID 00811313013003 MEDONE SURGICAL INC	MedOne 3300	2020-05-18
GUDID 00811313012990 MEDONE SURGICAL INC	MedOne 3299	2020-05-18
GUDID 00811313012983 MEDONE SURGICAL INC	MedOne 3298	2020-05-18
GUDID 00811313012969 MEDONE SURGICAL INC	MedOne 3296	2020-05-18
GUDID 00811313012952 MEDONE SURGICAL INC	MedOne 3295	2020-05-18
GUDID 00811313012907 MEDONE SURGICAL INC	MedOne 3290	2020-05-18
GUDID 00811313012860 MEDONE SURGICAL INC	MedOne 3286	2020-05-18
GUDID 00811313012792 MEDONE SURGICAL INC	MedOne 3279	2020-05-18
GUDID 00811313012785 MEDONE SURGICAL INC	MedOne 3278	2020-05-18
GUDID 00811313012761 MEDONE SURGICAL INC	MedOne 3276	2020-05-18
GUDID 00811313012754 MEDONE SURGICAL INC	MedOne 3275	2020-05-18
GUDID 00811313012730 MEDONE SURGICAL INC	MedOne 3273	2020-05-18
GUDID 00811313012723 MEDONE SURGICAL INC	MedOne 3272	2020-05-18
GUDID 00811313012693 MEDONE SURGICAL INC	MedOne 3269	2020-05-18
GUDID 00811313012686 MEDONE SURGICAL INC	MedOne 3268	2020-05-18
GUDID 00811313012662 MEDONE SURGICAL INC	MedOne 3266	2020-05-18
GUDID 00811313012648 MEDONE SURGICAL INC	MedOne 3264	2020-05-18
GUDID 00811313012624 MEDONE SURGICAL INC	MedOne 3262	2020-05-18
GUDID 00811313012600 MEDONE SURGICAL INC	MedOne 3260	2020-05-18
GUDID 00811313012594 MEDONE SURGICAL INC	MedOne 3259	2020-05-18
GUDID 00811313012587 MEDONE SURGICAL INC	MedOne 3258	2020-05-18
GUDID 00811313012570 MEDONE SURGICAL INC	MedOne 3257	2020-05-18
GUDID 00811313012563 MEDONE SURGICAL INC	MedOne 3256	2020-05-18
GUDID 00811313012556 MEDONE SURGICAL INC	MedOne 3255	2020-05-18
GUDID 00811313012549 MEDONE SURGICAL INC	MedOne 3254	2020-05-18
GUDID 00811313012525 MEDONE SURGICAL INC	MedOne 3252	2020-05-18
GUDID 00811313012518 MEDONE SURGICAL INC	MedOne 3251	2020-05-18
GUDID 00811313012488 MEDONE SURGICAL INC	MedOne 3248	2020-05-18
GUDID 00811313012471 MEDONE SURGICAL INC	MedOne 3247	2020-05-18
GUDID 00811313012464 MEDONE SURGICAL INC	MedOne 3246	2020-05-18
GUDID 00811313012457 MEDONE SURGICAL INC	MedOne 3245	2020-05-18
GUDID 00811313012433 MEDONE SURGICAL INC	MedOne 3243	2020-05-18
GUDID 00811313012426 MEDONE SURGICAL INC	MedOne 3242	2020-05-18
GUDID 00811313012419 MEDONE SURGICAL INC	MedOne 3241	2020-05-18
GUDID 00811313012402 MEDONE SURGICAL INC	MedOne 3240	2020-05-18
GUDID 00811313012396 MEDONE SURGICAL INC	MedOne 3239	2020-05-18
GUDID 00811313012389 MEDONE SURGICAL INC	MedOne 3238	2020-05-18
GUDID 00811313012372 MEDONE SURGICAL INC	MedOne 3237	2020-05-18
GUDID 00811313012358 MEDONE SURGICAL INC	MedOne 3235	2020-05-18
GUDID 00811313012341 MEDONE SURGICAL INC	MedOne 3234	2020-05-18
GUDID 00811313012334 MEDONE SURGICAL INC	MedOne 3233	2020-05-18
GUDID 00811313012327 MEDONE SURGICAL INC	MedOne 3232	2020-05-18
GUDID 00811313012310 MEDONE SURGICAL INC	MedOne 3231	2020-05-18
GUDID 00811313012303 MEDONE SURGICAL INC	MedOne 3230	2020-05-18
GUDID 00811313012297 MEDONE SURGICAL INC	MedOne 3229	2020-05-18
GUDID 00811313012280 MEDONE SURGICAL INC	MedOne 3228	2020-05-18
GUDID 00811313012266 MEDONE SURGICAL INC	MedOne 3226	2020-05-18
GUDID 00811313012259 MEDONE SURGICAL INC	MedOne 3225	2020-05-18
GUDID 00811313012242 MEDONE SURGICAL INC	MedOne 3224	2020-05-18
GUDID 00811313012235 MEDONE SURGICAL INC	MedOne 3223	2020-05-18
GUDID 00811313012228 MEDONE SURGICAL INC	MedOne 3222	2020-05-18
GUDID 00811313012211 MEDONE SURGICAL INC	MedOne 3221	2020-05-18
GUDID 00811313012204 MEDONE SURGICAL INC	MedOne 3220	2020-05-18
GUDID 00811313012198 MEDONE SURGICAL INC	MedOne 3219	2020-05-18
GUDID 00811313012181 MEDONE SURGICAL INC	MedOne 3218	2020-05-18
GUDID 00811313012150 MEDONE SURGICAL INC	MedOne 3215	2020-05-18
GUDID 00811313012143 MEDONE SURGICAL INC	MedOne 3214	2020-05-18
GUDID 00811313012112 MEDONE SURGICAL INC	MedOne 3211	2020-05-18
GUDID 00811313012105 MEDONE SURGICAL INC	MedOne 3210	2020-05-18
GUDID 00811313012099 MEDONE SURGICAL INC	MedOne 3209	2020-05-18
GUDID 00811313012082 MEDONE SURGICAL INC	MedOne 3208	2020-05-18
GUDID 00811313012075 MEDONE SURGICAL INC	MedOne 3207	2020-05-18
GUDID 00811313012068 MEDONE SURGICAL INC	MedOne 3206	2020-05-18
GUDID 00811313012051 MEDONE SURGICAL INC	MedOne 3205	2020-05-18
GUDID 00811313012044 MEDONE SURGICAL INC	MedOne 3204	2020-05-18
GUDID 00811313012037 MEDONE SURGICAL INC	MedOne 3203	2020-05-18
GUDID 00811313012020 MEDONE SURGICAL INC	MedOne 3202	2020-05-18
GUDID 00811313012013 MEDONE SURGICAL INC	MedOne 3201	2020-05-18
GUDID 10811313012744 MEDONE SURGICAL INC	MedOne 3274	2020-05-14
GUDID 00811313012006 MEDONE SURGICAL INC	MedOne 3200	2020-05-11
KDD MEDONE SURGICAL, INC.	MedOne	2016-08-04
NGY MEDONE SURGICAL, INC.	MedOne	2013-12-06
HND MEDONE SURGICAL, INC.	MedOne	2001-06-19
HND MEDONE SURGICAL, INC.	EyeTech	2001-06-19
HNR MEDONE SURGICAL, INC.	MedOne	2001-02-05
HNR MEDONE SURGICAL, INC.	EyeTech	2001-02-05
HNF MEDONE SURGICAL, INC.	MedOne	2001-02-05
HNF MEDONE SURGICAL, INC.	EyeTech	2001-02-05
JZB MEDONE SURGICAL, INC.	MedOne	1999-10-27
JZB MEDONE SURGICAL, INC.	Auricle	1999-10-27
HNY MEDONE SURGICAL, INC.	MedOne	1999-10-27
HNN MEDONE SURGICAL, INC.	MedOne	1999-10-27
HNN MEDONE SURGICAL, INC.	AdvantEdge	1999-10-27
HMX MEDONE SURGICAL, INC.	SideFlo	1999-10-27
HMX MEDONE SURGICAL, INC.	PolyTip	1999-10-27
HMX MEDONE SURGICAL, INC.	MedOne	1999-10-27
HMX MEDONE SURGICAL, INC.	FlexTip	1999-10-27
GAA MEDONE SURGICAL, INC.	MedOne	1999-10-27

Related Finance Registrations

NCAGE Code	4F7A2	MEDONE SURGICAL INC
CAGE Code	4F7A2	MEDONE SURGICAL INC
S.A.M. Registration	4F7A2 [4626680]	MEDONE SURGICAL INC

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2019080946448	Tokyo ,Japan -> Los Angeles, California	(14 CARTONS) MEDICAL GOODS CUSTOMER'S PO1950 9018.32.0000 . . .	14 CTN
2019071045541	Tokyo ,Japan -> Los Angeles, California	(16 CARTONS) MEDICAL GOODS CUSTOMER'S PO1950 9018.32 . . .	16 CTN
2019070465132	Tokyo ,Japan -> Los Angeles, California	(16 CARTONS) MEDICAL GOODS CUSTOMER'S PO1950 9018.32 . . .	16 CTN
2018020248592	Tokyo ,Japan -> Los Angeles, California	BULK NEEDLES	18 CTN