Maruho Medical Inc

FDA Filings

This page includes the latest FDA filings for Maruho Medical 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: 3015191037
• FEI Number: 3015191037
• Name: MARUHO MEDICAL INC
• Owner & Operator: Maruho Medical
• Contact Address: 8748 Technology Way ; Reno NV 89523 US
• Official Correspondent:
  • Ryan Toadvine
  • 1-770-3626739-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 8748 Technology Way ; Reno, NV 89523 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

• Registration Number: 3010841252
• FEI Number: 3010841252
• Name: Maruho Medical Inc.
• Owner & Operator: Maruho Medical
• Contact Address: 8748 Technology Way ; Reno NV 89523 US
• Official Correspondent:
  • Ryan Toadvine
  • 1-770-3626739-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 200 Cobb Parkway N Building 200, Suite 210; Marietta, GA 30062 US
• Establishment Type:
  • Complaint File Establishment per 21 CFR 820.198
  • Repack or Relabel Medical Device

FDA Filings

Device Company	Device	Date
GUDID 10818614022649 Maruho Medical, Inc.	ABS Med Distraction Pin	2023-09-06
GUDID 00818614022635 Maruho Medical, Inc.	ABS Med Distraction Pin	2023-09-06
GUDID 10818614022618 Maruho Medical, Inc.	Distraction Pin, 14MM pouch	2023-06-02
GUDID 10818614022601 Maruho Medical, Inc.	Distraction Pin, 12MM pouch	2023-06-02
GUDID 10818614021413 Maruho Medical, Inc.	Distraction Screw	2023-06-02
GUDID 10818614021406 Maruho Medical, Inc.	Distraction Screw	2023-06-02
GUDID 10818614022588 Maruho Medical, Inc.	Distraction Screw, 14MM pouch	2022-09-09
GUDID 10818614022571 Maruho Medical, Inc.	Distraction Screw, 12MM pouch	2022-09-09
GUDID 00818614022567 Maruho Medical, Inc.	Distraction Screw, 14MM pouch	2022-09-09
GUDID 00818614022550 Maruho Medical, Inc.	Distraction Screw, 12MM Pouch	2022-09-09
GUDID 00818614021355 Maruho Medical, Inc.	Apollo Medial with needles	2022-09-09
GUDID 10818614022540 Maruho Medical, Inc.	Kopis Knotless Anchor	2022-05-18
GUDID 10818614022533 Maruho Medical, Inc.	Kopis Knotless Anchor	2022-05-18
GUDID 10818614022526 Maruho Medical, Inc.	Kopis Knotless Anchor	2022-05-18
GUDID 10818614022496 Maruho Medical, Inc.	Galen Small Joint Anchor	2022-05-18
GUDID 10818614022489 Maruho Medical, Inc.	Galen Small Joint Anchor	2022-05-18
GUDID 10818614021215 Maruho Medical, Inc.	Tri-Gate Notched Disposable Cannula	2022-05-18
GUDID 10818614020546 Maruho Medical, Inc.	Tri-Gate Disposable Cannula	2022-05-18
GUDID 10818614020539 Maruho Medical, Inc.	Tri-Gate Disposable Cannula	2022-05-18
GUDID 10818614020522 Maruho Medical, Inc.	Tri-Gate Disposable Cannula	2022-05-18
GUDID 10818614020515 Maruho Medical, Inc.	Tri-Gate Disposable Cannula	2022-05-18
GUDID 10818614020508 Maruho Medical, Inc.	Tri-Gate Disposable Cannula	2022-05-18
GUDID 10818614020492 Maruho Medical, Inc.	Tri-Gate Disposable Cannula	2022-05-18
GUDID 20818614022516 Maruho Medical, Inc.	Distraction Pin , 14MM Pouch 909-14-K	2022-05-16
GUDID 20818614022509 Maruho Medical, Inc.	Distraction Pin , 12MM Pouch 909-12-K	2022-05-16
GUDID 10818614022410 Maruho Medical, Inc.	Apollo	2022-04-08
GUDID 00818614022406 Maruho Medical, Inc.	apollo	2022-04-08
GUDID 00818614022390 Maruho Medical, Inc.	apollo	2022-04-08
GUDID 00818614022383 Maruho Medical, Inc.	apollo	2022-04-08
GUDID 00818614022376 Maruho Medical, Inc.	apollo	2022-04-08
GUDID 00818614022369 Maruho Medical, Inc.	apollo	2022-04-08
GUDID 00818614021829 Maruho Medical, Inc.	AlloSource 20mm ProChondrix Drill/Guide	2022-03-16
GUDID 00818614021812 Maruho Medical, Inc.	AlloSource 17mm ProChondrix Drill/Guide	2022-03-16
GUDID 00818614021805 Maruho Medical, Inc.	AlloSource 15mm ProChondrix Drill/Guide	2022-03-16
GUDID 00818614021799 Maruho Medical, Inc.	AlloSource 13mm Prochondrix Drill/Guide	2022-03-16
GUDID 00818614021782 Maruho Medical, Inc.	AlloSource 11mm ProChondrix Drill/Guide	2022-03-16
GUDID 00818614021775 Maruho Medical, Inc.	AlloSource 09mm ProChondrix Drill/Guide	2022-03-16
GUDID 10818614022434 Maruho Medical, Inc.	itto	2021-10-04
GUDID 10818614022427 Maruho Medical, Inc.	itto	2021-10-04
GUDID 00818614022475 Maruho Medical, Inc.	itto CSP	2021-10-04
GUDID 00818614021362 Maruho Medical, Inc.	Apollo	2021-09-28
GUDID 00818614022468 Maruho Medical, Inc.	SSA	2021-07-12
GUDID 00818614022451 Maruho Medical, Inc.	SSA	2021-07-12
GUDID 00818614022444 Maruho Medical, Inc.	SSA	2021-07-12
GUDID 00818614021836 Maruho Medical, Inc.	AlloSource ProChondrix Sizer Set	2021-05-25
GUDID 10818614020645 Maruho Medical, Inc.	Apollo	2021-04-15
GUDID 10818614020638 Maruho Medical, Inc.	Apollo	2021-04-15
GUDID 00818614021874 Maruho Medical, Inc.	N/A	2021-03-25
GUDID 10818614022359 Maruho Medical, Inc.	apollo	2021-03-08
GUDID 10818614021956 Maruho Medical, Inc.	apollo	2021-03-08
GUDID 10818614021949 Maruho Medical, Inc.	apollo	2021-03-08
GUDID 00818614022345 Maruho Medical, Inc.	Titan	2021-03-08
GUDID 00818614022321 Maruho Medical, Inc.	N/A	2021-03-08
GUDID 00818614022314 Maruho Medical, Inc.	N/A	2021-03-08
GUDID 00818614022307 Maruho Medical, Inc.	N/A	2021-03-08
GUDID 00818614022291 Maruho Medical, Inc.	N/A	2021-03-08
GUDID 00818614022284 Maruho Medical, Inc.	N/A	2021-03-08
GUDID 00818614022277 Maruho Medical, Inc.	N/A	2021-03-08
GUDID 00818614022260 Maruho Medical, Inc.	N/A	2021-03-08
GUDID 00818614022253 Maruho Medical, Inc.	N/A	2021-03-08
GUDID 00818614022246 Maruho Medical, Inc.	N/A	2021-03-08
GUDID 00818614022239 Maruho Medical, Inc.	N/A	2021-03-08
GUDID 00818614022222 Maruho Medical, Inc.	N/A	2021-03-08
GUDID 00818614022215 Maruho Medical, Inc.	N/A	2021-03-08
GUDID 00818614022208 Maruho Medical, Inc.	N/A	2021-03-08
GUDID 00818614022192 Maruho Medical, Inc.	N/A	2021-03-08
GUDID 00818614022185 Maruho Medical, Inc.	Bonecam	2021-03-08
GUDID 00818614022178 Maruho Medical, Inc.	Bonecam	2021-03-08
GUDID 00818614022161 Maruho Medical, Inc.	N/A	2021-03-08
GUDID 00818614022154 Maruho Medical, Inc.	Bonecam	2021-03-08
GUDID 00818614022123 Maruho Medical, Inc.	Bonecam	2021-03-08
GUDID 00818614022116 Maruho Medical, Inc.	Bonecam	2021-03-08
GUDID 00818614022109 Maruho Medical, Inc.	Bonecam	2021-03-08
GUDID 00818614022093 Maruho Medical, Inc.	Bonecam	2021-03-08
GUDID 00818614022086 Maruho Medical, Inc.	Bonecam	2021-03-08
GUDID 00818614022079 Maruho Medical, Inc.	Bonecam	2021-03-08
GUDID 00818614022048 Maruho Medical, Inc.	Titan	2021-03-08
GUDID 00818614022024 Maruho Medical, Inc.	Titan	2021-03-08
GUDID 00818614022017 Maruho Medical, Inc.	Titan	2021-03-08
GUDID 00818614022000 Maruho Medical, Inc.	Titan	2021-03-08
GUDID 00818614021997 Maruho Medical, Inc.	Titan	2021-03-08
GUDID 00818614021980 Maruho Medical, Inc.	Titan	2021-03-08
GUDID 00818614021904 Maruho Medical, Inc.	N/A	2021-03-08
GUDID 00818614022147 Maruho Medical, Inc.	Bonecam	2021-03-05
GUDID 00818614022130 Maruho Medical, Inc.	Apollo	2021-03-05
GUDID 00818614022062 Maruho Medical, Inc.	Apollo	2021-03-05
GUDID 00818614022055 Maruho Medical, Inc.	Apollo	2021-03-05
GUDID 00818614022338 Maruho Medical, Inc.	Titan	2021-03-04
GUDID 00818614022031 Maruho Medical, Inc.	Titan	2021-03-04
GUDID 00818614021973 Maruho Medical, Inc.	Titan	2021-03-04
GUDID 00818614021966 Maruho Medical, Inc.	Titan	2021-03-04
GUDID 00818614021911 Maruho Medical, Inc.	Titan	2021-03-04
GUDID 00818614021898 Maruho Medical, Inc.	Titan	2021-03-04
GUDID 00818614021881 Maruho Medical, Inc.	Titan	2021-03-04
GUDID 00818614021867 Maruho Medical, Inc.	Titan	2021-03-04
GUDID 00818614021850 Maruho Medical, Inc.	Titan	2021-03-04
GUDID 00818614021843 Maruho Medical, Inc.	Titan	2021-03-04
PMN K160304 | HWC Maruho Medical Inc. [Maruho Medical]	OsteoBullet Compression Screw	2020-04-17
PMN K160194 | HTY Maruho Medical Inc. [Maruho Medical]	StarFuse Interphalangeal Pin	2020-04-17
LXH Maruho Medical Inc. [Maruho Medical]	Tissue Grasper, Straight 2.7mm	2020-04-17
LXH Maruho Medical Inc. [Maruho Medical]	Tissue Elevator, 15 degree Angled	2020-04-17
LXH Maruho Medical Inc. [Maruho Medical]	Suture Retriever, Straight	2020-04-17
LXH Maruho Medical Inc. [Maruho Medical]	Suture Passer	2020-04-17
LXH Maruho Medical Inc. [Maruho Medical]	Suture Passer Disposable Needle	2020-04-17
LXH Maruho Medical Inc. [Maruho Medical]	Suture Cutter	2020-04-17
LXH Maruho Medical Inc. [Maruho Medical]	Knot Pusher	2020-04-17
LXH Maruho Medical Inc. [Maruho Medical]	Debridement Rasp	2020-04-17
LXH Maruho Medical Inc. [Maruho Medical]	Birdy, Straight	2020-04-17
LXH Maruho Medical Inc. [Maruho Medical]	Birdy, 45 degree Right-Bend	2020-04-17
LXH Maruho Medical Inc. [Maruho Medical]	Birdy, 45 degree Left-Bend	2020-04-17
LXH Maruho Medical Inc. [Maruho Medical]	Birdy, 40 degree Up	2020-04-17
LXH Maruho Medical Inc. [Maruho Medical]	Birdy, 20 degree up	2020-04-17
LXH Maruho Medical Inc. [Maruho Medical]	Arthroscopic Instruments	2020-04-17
KDD Maruho Medical Inc. [Maruho Medical]	Titan Disposable Kit	2020-04-17
HTW Maruho Medical Inc. [Maruho Medical]	BoneCam Drill	2020-04-17
GEA Maruho Medical Inc. [Maruho Medical]	Cannula System	2020-04-17
PMN K152255 | MBI Maruho Medical Inc. [Maruho Medical]	BoneCam	2020-04-16
PMN K142230 | MBI Maruho Medical Inc. [Maruho Medical]	Apollo XT	2020-04-16
PMN K133036 | MBI Maruho Medical Inc. [Maruho Medical]	Apollo	2020-04-16
HWQ MARUHO MEDICAL INC [Maruho Medical]	itto SL40 Shuttle Loop	2018-12-03
HWQ MARUHO MEDICAL INC [Maruho Medical]	itto SL4 Shuttle Loop	2018-12-03
HWQ MARUHO MEDICAL INC [Maruho Medical]	itto CSP and itto SS	2018-12-03
HWQ MARUHO MEDICAL INC [Maruho Medical]	itto CSP Max Suture Passer	2018-12-03