Owen Mumford Usa Inc

FDA Filings

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

Owen Mumford Usa Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• TRAVIS SHAW
• Owen Mumford Limited
• Owen Mumford Sdn Bhd

FDA Registration(s)

• Registration Number: 1058602
• FEI Number: 1000219614
• Name: OWEN MUMFORD USA, INC.
• Owner & Operator: OWEN MUMFORD, LTD.
• Contact Address: BROOK HILL WOODSTOCK; OXFORDSHIRE GB-NOTA 0X20ITU GB
• Official Correspondent:
  • Darren Mansell
  • 44-1993-812021-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 1755 WEST OAK COMMONS CT. ; MARIETTA, GA 30062 US
• Establishment Type:
  • Repack or Relabel Medical Device
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 00761059354024 OWEN MUMFORD USA INCORPORATED	Unifine Pentips	2024-02-13
GUDID 00761059352921 OWEN MUMFORD USA INCORPORATED	Unifine Pentips	2024-01-30
GUDID 00384707522035 OWEN MUMFORD USA INCORPORATED	Unistik ShieldLock	2023-10-16
GUDID 00384707517031 OWEN MUMFORD USA INCORPORATED	Unistik ShieldLock	2023-10-16
GUDID 00384707512036 OWEN MUMFORD USA INCORPORATED	Unistik ShieldLock	2023-10-16
GUDID 00384707322031 OWEN MUMFORD USA INCORPORATED	Unistik ShieldLock	2023-10-16
GUDID 00384707317037 OWEN MUMFORD USA INCORPORATED	Unistik ShieldLock	2023-10-16
GUDID 00384707312032 OWEN MUMFORD USA INCORPORATED	Unistik ShieldLock	2023-10-16
GUDID 00384707122037 OWEN MUMFORD USA INCORPORATED	Unistik ShieldLock	2023-10-16
GUDID 00384707117033 OWEN MUMFORD USA INCORPORATED	Unistik ShieldLock	2023-10-16
GUDID 00384707102039 OWEN MUMFORD USA INCORPORATED	Unistik VacuFlip	2023-10-16
GUDID 00384707001035 OWEN MUMFORD USA INCORPORATED	Unistik VacuFlip	2023-10-16
GUDID 00384707502037 OWEN MUMFORD USA INCORPORATED	Unistik ShieldLock	2023-10-09
GUDID 00384707302033 OWEN MUMFORD USA INCORPORATED	Unistik ShieldLock	2023-10-09
GUDID 00384707112038 OWEN MUMFORD USA INCORPORATED	Unistik ShieldLock	2023-10-09
GUDID 00384707100035 OWEN MUMFORD USA INCORPORATED	Unistik ShieldLock	2023-10-09
GUDID 00384707905036 OWEN MUMFORD USA INCORPORATED	Unistik	2023-10-02
GUDID 00384707900031 OWEN MUMFORD USA INCORPORATED	Unistik	2023-10-02
GUDID 00384707252031 OWEN MUMFORD USA INCORPORATED	Unistik VacuFlip	2023-10-02
GUDID 00384707251034 OWEN MUMFORD USA INCORPORATED	Unistik VacuFlip	2023-10-02
GUDID 00384707226032 OWEN MUMFORD USA INCORPORATED	Unistik VacuFlip	2023-10-02
GUDID 00384707225035 OWEN MUMFORD USA INCORPORATED	Unistik VacuFlip	2023-10-02
GUDID 00384707202036 OWEN MUMFORD USA INCORPORATED	Unistik VacuFlip	2023-10-02
GUDID 00384707201039 OWEN MUMFORD USA INCORPORATED	Unistik VacuFlip	2023-10-02
GUDID 00384707152034 OWEN MUMFORD USA INCORPORATED	Unistik VacuFlip	2023-10-02
GUDID 00384707151037 OWEN MUMFORD USA INCORPORATED	Unistik VacuFlip	2023-10-02
GUDID 00384707126035 OWEN MUMFORD USA INCORPORATED	Unistik VacuFlip	2023-10-02
GUDID 00384707125038 OWEN MUMFORD USA INCORPORATED	Unistik VacuFlip	2023-10-02
GUDID 00384707101032 OWEN MUMFORD USA INCORPORATED	Unistik VacuFlip	2023-10-02
GUDID 00384707052037 OWEN MUMFORD USA INCORPORATED	Unistik VacuFlip	2023-10-02
GUDID 00384707051030 OWEN MUMFORD USA INCORPORATED	Unistik VacuFlip	2023-10-02
GUDID 00384707026038 OWEN MUMFORD USA INCORPORATED	Unistik VacuFlip	2023-10-02
GUDID 00384707025031 OWEN MUMFORD USA INCORPORATED	Unistik VacuFlip	2023-10-02
GUDID 00384707002032 OWEN MUMFORD USA INCORPORATED	Unistik VacuFlip	2023-10-02
GUDID 00761059490029 OWEN MUMFORD USA INCORPORATED	Pentips 1st Tier	2023-07-03
GUDID 00761059450023 OWEN MUMFORD USA INCORPORATED	Pentips 1st Tier	2023-07-03
GUDID 00761059440024 OWEN MUMFORD USA INCORPORATED	Pentips 1st Tier	2023-07-03
GUDID 00761059430025 OWEN MUMFORD USA INCORPORATED	Pentips 1st Tier	2023-07-03
GUDID 00761059429029 OWEN MUMFORD USA INCORPORATED	Pentips 1st Tier	2023-07-03
GUDID 00384707940020 OWEN MUMFORD USA INCORPORATED	Unfine SafeControl	2023-07-03
GUDID 00384706150017 OWEN MUMFORD USA INCORPORATED	AutoSqueeze	2023-06-28
GUDID 00384706050010 OWEN MUMFORD USA INCORPORATED	AutoDrop	2023-06-28
GUDID 00384702009012 OWEN MUMFORD USA INCORPORATED	Rapport	2023-06-28
GUDID 00384706100012 OWEN MUMFORD USA INCORPORATED	AutoSqueeze	2023-06-15
GUDID 00384706000022 OWEN MUMFORD USA INCORPORATED	AutoDrop	2023-06-15
GUDID 00761059657002 OWEN MUMFORD USA INCORPORATED	1st Tier Unilet Comfortouch	2023-04-07
GUDID 00761059585008 OWEN MUMFORD USA INCORPORATED	1st Tier Unilet	2023-04-07
GUDID 00761059575009 OWEN MUMFORD USA INCORPORATED	1st Tier Unilet	2023-04-07
GUDID 00761059565000 OWEN MUMFORD USA INCORPORATED	1st Tier Unilet	2023-04-07
GUDID 00761059257004 OWEN MUMFORD USA INCORPORATED	1st Tier Unilet Comfortouch	2023-04-07
GUDID 00384701267024 OWEN MUMFORD USA INCORPORATED	Unistik TinyTouch	2023-03-30
GUDID 00384701260032 OWEN MUMFORD USA INCORPORATED	Unistik TinyTouch	2023-03-30
GUDID 00384701250026 OWEN MUMFORD USA INCORPORATED	Unistik TinyTouch	2023-03-30
GUDID 00384701210037 OWEN MUMFORD USA INCORPORATED	Unistik TinyTouch	2023-03-30
GUDID 00384701200021 OWEN MUMFORD USA INCORPORATED	Unistik TinyTouch	2023-03-30
GUDID 00384700272012 OWEN MUMFORD USA INCORPORATED	Autolet	2023-03-30
GUDID 00384700271039 OWEN MUMFORD USA INCORPORATED	Autolet	2023-03-09
GUDID 00384700270025 OWEN MUMFORD USA INCORPORATED	Autolet	2023-02-15
GUDID 00384701028038 OWEN MUMFORD USA INCORPORATED	Unistik 3	2022-10-26
GUDID 00038470310039 OWEN MUMFORD USA INCORPORATED	Amielle Restore	2022-10-21
GUDID 00384703495029 OWEN MUMFORD USA INCORPORATED	Pentips	2022-08-15
GUDID 00761059590873 OWEN MUMFORD USA INCORPORATED	TopRx 1st Tier UP	2022-06-10
GUDID 00761059551874 OWEN MUMFORD USA INCORPORATED	TopRx 1st Tier UP	2022-06-10
GUDID 00761059531876 OWEN MUMFORD USA INCORPORATED	TopRx 1st Tier UP	2022-06-10
GUDID 00761059491873 OWEN MUMFORD USA INCORPORATED	TopRx 1st Tier Pentips	2022-06-10
GUDID 00761059451877 OWEN MUMFORD USA INCORPORATED	TopRx 1st Tier Pentips	2022-06-10
GUDID 00761059441878 OWEN MUMFORD USA INCORPORATED	TopRx 1st Tier Pentips	2022-06-10
GUDID 00761059431879 OWEN MUMFORD USA INCORPORATED	TopRx 1st Tier Pentips	2022-06-10
GUDID 00761059420873 OWEN MUMFORD USA INCORPORATED	TopRx 1st Tier UP	2022-06-10
GUDID 00384703540002 OWEN MUMFORD USA INCORPORATED	TopRx 1st Tier UP	2022-06-10
GUDID 00384700190224 OWEN MUMFORD USA INCORPORATED	Unifine Ultra	2022-03-28
GUDID 00384700150228 OWEN MUMFORD USA INCORPORATED	Unifine Ultra	2022-03-28
GUDID 00384700130220 OWEN MUMFORD USA INCORPORATED	Unifine Ultra	2022-03-28
GUDID 00384704190039 OWEN MUMFORD USA INCORPORATED	Unifine Ultra	2022-03-21
GUDID 00384704150033 OWEN MUMFORD USA INCORPORATED	Unifine Ultra	2022-03-21
GUDID 00384704140034 OWEN MUMFORD USA INCORPORATED	Unifine Ultra	2022-03-21
GUDID 00384704130035 OWEN MUMFORD USA INCORPORATED	Unifine Ultra	2022-03-21
GUDID 00384700140229 OWEN MUMFORD USA INCORPORATED	Unifine Ultra	2022-03-21
GUDID 00761059591856 OWEN MUMFORD USA INCORPORATED	South Pointe Wholesale - Unifine Pentips	2021-11-15
GUDID 00761059551850 OWEN MUMFORD USA INCORPORATED	South Pointe Wholesale - Unifine Pentips	2021-11-15
GUDID 00761059541851 OWEN MUMFORD USA INCORPORATED	South Pointe Wholesale - Unifine Pentips	2021-11-15
GUDID 00761059531852 OWEN MUMFORD USA INCORPORATED	South Pointe Wholesale - Unifine Pentips	2021-11-15
GUDID 00761059891192 OWEN MUMFORD USA INCORPORATED	Kinray 1st Tier Unifine Pentips Plus	2021-08-05
GUDID 00761059851653 OWEN MUMFORD USA INCORPORATED	Spartan Nash 1st Tier Unifine Pentips Plus	2021-08-05
GUDID 00761059851196 OWEN MUMFORD USA INCORPORATED	Kinray 1st Tier Unifine Pentips Plus	2021-08-05
GUDID 00761059841197 OWEN MUMFORD USA INCORPORATED	Kinray 1st Tier Unifine Pentips Plus	2021-08-05
GUDID 00761059831198 OWEN MUMFORD USA INCORPORATED	Kinray 1st Tier Unifine Pentips Plus	2021-08-05
GUDID 00761059820192 OWEN MUMFORD USA INCORPORATED	Kinray 1st Tier Unifine Pentips Plus	2021-08-05
GUDID 00384703840003 OWEN MUMFORD USA INCORPORATED	Spartan Nash 1st Tier Unifine Pentips Plus	2021-08-05
GUDID 00761059861843 OWEN MUMFORD USA INCORPORATED	Diabetic Outlet 1st Tier - Unifine Pentips Plus 4mm x 33G	2021-06-04
GUDID 00761059841845 OWEN MUMFORD USA INCORPORATED	Diabetic Outlet 1st Tier - Unifine Pentips Plus 4mm x 32G	2021-06-04
GUDID 00761059491842 OWEN MUMFORD USA INCORPORATED	Diabetic Outlet 1st Tier - Pentips 6mm x 31G	2021-06-04
GUDID 00761059451846 OWEN MUMFORD USA INCORPORATED	Diabetic Outlet 1st Tier - Pentips 5mm x 31G	2021-06-04
GUDID 00761059441847 OWEN MUMFORD USA INCORPORATED	Diabetic Outlet 1st Tier - Pentips 4mm x 32G	2021-06-04
GUDID 00761059431848 OWEN MUMFORD USA INCORPORATED	Diabetic Outlet 1st Tier - Pentips 8mm x 31G	2021-06-04
GUDID 00761059891840 OWEN MUMFORD USA INCORPORATED	Diabetic Outlet 1st Tier - Unifine Pentips Plus 6mm x 31G	2021-03-08
GUDID 00761059851844 OWEN MUMFORD USA INCORPORATED	Diabetic Outlet 1st Tier - Unifine Pentips Plus 5mm x 31G	2021-03-08
GUDID 00384700855239 OWEN MUMFORD USA INCORPORATED	Unifine Pentips Plus RapidFlow 5mm x 30G Sample Bags	2021-03-08
GUDID 00384700555238 OWEN MUMFORD USA INCORPORATED	Unfine Pentips RapidFlow 5mm x 30G Sample Bags	2021-03-08
GUDID 00384703860001 OWEN MUMFORD USA INCORPORATED	Premier Value 1st Tier Unifine Pentips Plus - 4mm x 33G Sample Bags	2021-02-08
PMN K173881 | FMI OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]	Unifine SafeControl	2019-10-11
PMN K152339 | FMI OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]	Unifine Pentips	2016-07-05
PMN K152339 | FMI OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]	Unifine Pentips Plus	2016-07-05
PMN K152339 | FMI OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]	Pentips	2016-07-05
PMN K973899 | FMI OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]	Unifine Pentips	2010-06-16
PMN K973899 | FMI OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]	Unifine Pentips Plus	2010-06-16
PMN K983045 | KXP OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]	Amielle	2007-10-31
PMN K945660 | KZH OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]	Rebiject II	2007-10-31
PMN K945660 | KZH OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]	Fixed Needle	2007-10-31
PMN K945660 | KZH OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]	Autoject 2	2007-10-31
PMN K895890 | FMF OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]	Autopen Classic	2007-10-31
PMN K983974 | FMF OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]	Autopen Classic 3.0ml	2006-12-28
PMN K013362 OWEN MUMFORD USA, INC.	AUTOJECT 2	2001-11-13
PMN K993385 Owen Mumford USA, Inc.	AUTOJET 2 (NON-FIXED NEEDLE TYPE)	1999-11-10
PMN K983994 Owen Mumford USA, Inc.	UNIFINE	1999-01-08
PMN K983974 Owen Mumford USA, Inc.	OWEN MUMFORD 3ML AUTOPEN	1998-12-21
PMN K982275 Owen Mumford USA, Inc.	RAPPORT V.T.D.	1998-12-04
PMN K983045 Owen Mumford USA, Inc.	AMIELLE	1998-11-25
PMN K973899 Owen Mumford USA, Inc.	UNIFINE PENTIPS	1997-12-04
LKY OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]	RAPPORT V.T.D.	1997-11-13
LKY OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]	Constriction Ring size 9	1997-11-13
LKY OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]	Constriction Ring size 8	1997-11-13
LKY OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]	Constriction Ring size 7	1997-11-13
LKY OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]	Constriction Ring size 6	1997-11-13
LKY OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]	Constriction Ring size 5	1997-11-13
LKY OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]	Constriction Ring size 4	1997-11-13
LKY OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]	Constriction Ring size 3	1997-11-13
PMN K971443 OWEN MUMFORD USA, INC.	RAPPORT V.T.D.	1997-09-26
PMN K953735 OWEN MUMFORD USA, INC.	AUTOJECT MINI	1995-11-08
PMN K945660 OWEN MUMFORD USA, INC.	AUTOJECT 2	1995-08-11
PMN K993385 | KZH OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]	Extavia Auto-Injector II	1992-12-02
PMN K993385 | KZH OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]	Betaject Lite	1992-12-02
PMN K993385 | KZH OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]	AUTOJECT 2 (NON-FIXED NEEDLE)	1992-12-02
KCM OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]	AUTOSQUEEZE	1992-12-02
KCM OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]	AUTODROP	1992-12-02
GXB OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]	NEUROTIP	1992-12-02
GXB OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]	NEUROPEN	1992-12-02
FMK OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]	Unistik Touch	1992-12-02
FMK OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]	Unistik TinyTouch	1992-12-02
FMK OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]	Unistik Pro	1992-12-02
FMK OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]	Unistik 3	1992-12-02
FMK OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]	Unistik 2	1992-12-02
FMK OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]	Unilet ComforTouch	1992-12-02
FMK OWEN MUMFORD USA, INC. [OWEN MUMFORD, LTD.]	Autolet Plus	1992-12-02

Related Finance Registrations

CAGE Code	0YN49	OWEN MUMFORD USA INCORPORATED OWEN MUMFORD, INC.
S.A.M. Registration	0YN49 [803401454]	OWEN MUMFORD USA INCORPORATED

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020091436347	Genova,Italy -> Savannah, Georgia	PEN NEEDLES H.S. CODE 901832	23 PCS
2020081319117	Xingang,China (Mainland) -> Savannah, Georgia	DISPOSABLE STERILE LANCET	615 CTN
2020072020508	Genova,Italy -> Savannah, Georgia	PEN NEEDLES H.S. CODE 901832	20 PCS
2020070111507	Pusan,South Korea -> Savannah, Georgia	DISPOSABLE STERILE LANCETS	1216 CTN
2020063017074	Pusan,South Korea -> Savannah, Georgia	DISPOSABLE STERILE LANCETS	1216 CTN
2020062715880	Pusan,South Korea -> Savannah, Georgia	DISPOSABLE STERILE LANCETS	1216 CTN
2020062321372	Genova,Italy -> Savannah, Georgia	PEN NEEDLES H.S. CODE 901832	23 PCS
202005181436	Pusan,South Korea -> Savannah, Georgia	DISPOSABLE STERILE LANCET	924 CTN