This page includes the latest FDA filings for Lake Region Medical. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
Lake Region Medical holds import registrations or U.S. agent authorizations in conjunction with the following organizations:
Registration Number | 2126666 |
FEI Number | 2126666 |
Name | Lake Region Medical |
Owner & Operator | Lake Region Medical |
Contact Address | 340 Lake Hazeltine Drive -- Chaska MN 55318 US |
Official Correspondent |
|
Registration Status | 1 |
Initial Importer | Y |
Registration Expiration | 2020-04-25 |
Registration Address | 340 Lake Hazeltine Dr CHASKA, MN 55318 US |
Establishment Type |
|
Registration Number | 9681477 |
FEI Number | 3002807439 |
Name | Karen Anderson |
Owner & Operator | Lake Region Medical |
Contact Address | 340 Lake Hazeltine Drive -- Chaska MN 55318 US |
Official Correspondent |
|
US Agent |
|
Registration Status | 1 |
Initial Importer | N |
Registration Expiration | 2020-04-25 |
Registration Address | 340 Lake Hazeltine Dr CHASKA, MN 55318 US |
Establishment Type |
|
Registration Number | 2431982 |
FEI Number | 2431982 |
Name | Venusa Ltd. |
Owner & Operator | Lake Region Medical |
Contact Address | 100 FORDHAM ROAD BLDG C Wilmington MA 01887 US |
Registration Status | 1 |
Initial Importer | Y |
Registration Expiration | 2020-04-25 |
Registration Address | 31 BUTTERFIELD TRAIL BLVD STE C EL PASO, TX 79906 US |
Registration Number | 9680001 |
FEI Number | 3002808445 |
Name | Venusa de Mexico S. de R.L de C.V |
Owner & Operator | Lake Region Medical |
Contact Address | 100 FORDHAM ROAD BLDG C Wilmington MA 01887 US |
US Agent |
|
Registration Status | 1 |
Initial Importer | N |
Registration Expiration | 2020-04-25 |
Registration Address | CALLE HERTZ 1525 Parque Industrial Antonio J. Bermudez CIUDAD JUAREZ Chihuahua, 32470 MX |
Establishment Type |
|
Registration Number | 3004063494 |
FEI Number | 3004063494 |
Name | Lake Region Medical |
Owner & Operator | Lake Region Medical |
Contact Address | 100 FORDHAM ROAD BLDG C Wilmington MA 01887 US |
Registration Status | 1 |
Initial Importer | N |
Registration Expiration | 2020-04-25 |
Registration Address | 13024 NORTH MAIN ST. TRENTON, GA 30752 US |
Establishment Type | Manufacture Medical Device for Another Party (Contract Manufacturer) |
Device Company | Device | Date |
---|---|---|
Lake Region Medical | ZIPwire™ M006630217B0 | 2024-06-28 |
Lake Region Medical | ZIPwire™ M006630216B0 | 2024-06-28 |
Lake Region Medical | ZIPwire™ M006630215B0 | 2024-06-28 |
Lake Region Medical | ZIPwire™ M006630214B0 | 2024-06-28 |
Lake Region Medical | ZIPwire™ M006630213B0 | 2024-06-28 |
Lake Region Medical | ZIPwire™ M006630212B0 | 2024-06-28 |
Lake Region Medical | ZIPwire™ M006630210B0 | 2024-06-28 |
Lake Region Medical | ZIPwire™ M006630227B0 | 2024-06-28 |
Lake Region Medical | ZIPwire™ M006630226B0 | 2024-06-28 |
Lake Region Medical | ZIPwire™ M006630228B0 | 2024-06-28 |
Lake Region Medical | ZIPwire™ M006630224B0 | 2024-06-28 |
Lake Region Medical | ZIPwire™ M006630221B0 | 2024-06-28 |
Lake Region Medical | ZIPwire™ M006630203B0 | 2024-06-28 |
Lake Region Medical | ZIPwire™ M006630201B0 | 2024-06-28 |
Lake Region Medical | ZIPwire™ M006630202B0 | 2024-06-28 |
Lake Region Medical | ZIPwire™ M006630200B0 | 2024-06-28 |
Lake Region Medical | ZIPwire™ M006630225B0 | 2024-06-28 |
Lake Region Medical | ZIPwire™ M006630223B0 | 2024-06-28 |
Lake Region Medical | ZIPwire™ M006630209B0 | 2024-06-28 |
Lake Region Medical | ZIPwire™ M006630206B0 | 2024-06-28 |
Lake Region Medical | ZIPwire™ M006630205B0 | 2024-06-28 |
Lake Region Medical | ZIPwire™ M006630208B0 | 2024-06-28 |
Lake Region Medical | ZIPwire™ M006630222B0 | 2024-06-28 |
Lake Region Medical | SAFARI2™ H74939407L0 | 2024-06-26 |
Lake Region Medical | SAFARI2™ H74939406S0 | 2024-06-26 |
Lake Region Medical | SAFARI2™ H74939406L0 | 2024-06-26 |
Lake Region Medical | SAFARI™ H74939271S0 | 2024-06-26 |
Lake Region Medical | ZIPwire™ M006630207B0 | 2024-06-26 |
Lake Region Medical | AddWire™ H74922150010 | 2024-06-26 |
Lake Region Medical | SAFARI2™ H74939407S0 | 2024-06-19 |
Lake Region Medical | SAFARI2™ H74939407XS0 | 2024-06-19 |
Lake Region Medical | SAFARI2™ H74939406XS0 | 2024-06-19 |
Lake Region Medical | SAFARI™ H74939272L0 | 2024-06-19 |
Lake Region Medical | SAFARI™ H74939272S0 | 2024-06-19 |
Lake Region Medical | SAFARI™ H74939271L0 | 2024-06-19 |
Lake Region Medical | NaviPro™ | 2023-12-06 |
Lake Region Medical | NaviPro™ | 2023-12-06 |
Lake Region Medical | NaviPro™ | 2023-12-06 |
Lake Region Medical | NaviPro™ | 2023-12-06 |
Lake Region Medical | NaviPro™ | 2023-12-06 |
Lake Region Medical | NaviPro™ | 2023-12-06 |
Lake Region Medical | NaviPro™ | 2023-12-06 |
Lake Region Medical | NaviPro™ | 2023-12-06 |
Lake Region Medical | Circulo 15R2011-06-001 | 2022-10-21 |
Lake Region Medical | Circulo 15R2011-06-002 | 2022-10-21 |
Lake Region Medical | Pre-Formed Blue | 2022-10-07 |
Lake Region Medical | Safari2 Extra Support SCMBW-019V | 2022-04-01 |
Lake Region Medical | Safari2 Extra Support SCMBW-022V | 2022-04-01 |
Lake Region Medical | Safari2 Extra Support SCMBW-021V | 2022-04-01 |
Lake Region Medical | Safari2 Extra Support SCMBW-020V | 2022-04-01 |
Lake Region Medical | Safari2 Extra Support SCMBW-018V | 2022-04-01 |
Lake Region Medical | Safari2 Extra Support SCMBW-017V | 2022-04-01 |
Lake Region Medical | ZIPwire™ | 2021-12-22 |
Lake Region Medical | ZIPwire™ | 2021-12-22 |
Lake Region Medical | ZIPwire™ | 2021-12-22 |
Lake Region Medical | ZIPwire™ | 2021-12-22 |
Lake Region Medical | ZIPwire™ | 2021-12-22 |
Lake Region Medical | ZIPwire™ | 2021-12-22 |
Lake Region Medical | ZIPwire™ | 2021-12-22 |
Lake Region Medical | ZIPwire™ | 2021-12-22 |
Lake Region Medical | ZIPwire™ | 2021-12-22 |
Lake Region Medical | ZIPwire™ | 2021-12-22 |
Lake Region Medical | ZIPwire™ | 2021-12-22 |
Lake Region Medical | ZIPwire™ | 2021-12-22 |
Lake Region Medical | ZIPwire™ | 2021-12-22 |
Lake Region Medical | ZIPwire™ | 2021-12-22 |
Lake Region Medical | ZIPwire™ | 2021-12-22 |
Lake Region Medical | ZIPwire™ | 2021-12-22 |
Lake Region Medical | ZIPwire™ | 2021-12-22 |
Lake Region Medical | ZIPwire™ | 2021-12-22 |
Lake Region Medical | ZIPwire™ | 2021-12-22 |
Lake Region Medical | ZIPwire™ | 2021-12-22 |
Lake Region Medical | ZIPwire™ | 2021-12-22 |
Lake Region Medical | ZIPwire™ | 2021-12-22 |
Lake Region Medical | ZIPwire™ | 2021-12-22 |
Lake Region Medical | ZIPwire™ | 2021-12-22 |
Lake Region Medical | Thruway™ | 2021-12-22 |
Lake Region Medical | Thruway™ | 2021-12-22 |
Lake Region Medical | Thruway™ | 2021-12-22 |
Lake Region Medical | Thruway™ | 2021-12-22 |
Lake Region Medical | Thruway™ | 2021-12-22 |
Lake Region Medical | Thruway™ | 2021-12-22 |
Lake Region Medical | Thruway™ | 2021-12-22 |
Lake Region Medical | Thruway™ | 2021-12-22 |
Lake Region Medical | Thruway™ | 2021-12-22 |
Lake Region Medical | Thruway™ | 2021-12-22 |
Lake Region Medical | Thruway™ | 2021-12-22 |
Lake Region Medical | Thruway™ | 2021-12-22 |
Lake Region Medical | Thruway™ | 2021-12-22 |
Lake Region Medical | Thruway™ | 2021-12-22 |
Lake Region Medical | Thruway™ | 2021-12-22 |
Lake Region Medical | Thruway™ | 2021-12-22 |
Lake Region Medical | Thruway™ | 2021-12-22 |
Lake Region Medical | Thruway™ | 2021-12-22 |
Lake Region Medical | Thruway™ | 2021-12-22 |
Lake Region Medical | Thruway™ | 2021-12-22 |
Lake Region Medical | Thruway™ | 2021-12-22 |
Lake Region Medical | Thruway™ | 2021-12-22 |
Lake Region Medical | Thruway™ | 2021-12-22 |
Lake Region Medical | Thruway™ | 2021-12-22 |
Lake Region Medical | Thruway™ | 2021-12-22 |
Venusa de Mexico S. de R.L de C.V [Lake Region Medical] | Covidien Electrosurgical | 2020-04-02 |
Venusa de Mexico S. de R.L de C.V [Lake Region Medical] | Wire, Guide, Catheter | 2020-01-02 |
Venusa de Mexico S. de R.L de C.V [Lake Region Medical] | Wire, Guide, Catheter NaviPro | 2019-12-17 |
Venusa de Mexico S. de R.L de C.V [Lake Region Medical] | Wire, Guide, Catheter ZIPwire | 2019-12-17 |
Lake Region Medical | Callisyn 2.7Fr Microcatheter | 2018-08-20 |
LAKE REGION MEDICAL | ENROUTE 0.014 Guidewire | 2016-10-18 |
Lake Region Medical | Merit Medical EmboCath Plus | 2016-05-20 |
Venusa de Mexico S. de R.L de C.V [Lake Region Medical] | Synergetics | 2016-03-08 |
Venusa de Mexico S. de R.L de C.V [Lake Region Medical] | Intact Medical Corporation | 2016-02-16 |
Venusa de Mexico S. de R.L de C.V [Lake Region Medical] | DePuy Mitek | 2015-10-20 |
Venusa de Mexico S. de R.L de C.V [Lake Region Medical] | Depuy Mitek | 2015-10-20 |
Lake Region Medical | Pre-Formed Guidewire | 2015-06-11 |
Lake Region Medical | Infiniti Vision System (with I/A Tips (HQR being part of the System) | 2015-03-02 |
Lake Region Medical | Infiniti Vision System (with I/A Tips (HQR being part of the System) | 2015-03-02 |
Lake Region Medical | Infiniti Vision System (with I/A Tips (HQR being part of the System) | 2015-03-02 |
LAKE REGION MEDICAL | HI TORQUE CONNECT GUIDEWIRE, HI TORQUE CONNECT FLEX GUIDEWIRE, HI TORQUE CONNECT 250T GUIDEWIRE | 2014-12-17 |
LAKE REGION MEDICAL | PREDICATE III GUIDEWIRE | 2014-11-25 |
Lake Region Medical | Predicate III | 2014-10-30 |
Karen Anderson [Lake Region Medical] | Predicate III | 2014-10-30 |
Venusa de Mexico S. de R.L de C.V [Lake Region Medical] | St. Jude Medical | 2014-10-29 |
Lake Region Medical | Predicate III Guidewire | 2014-09-19 |
Venusa de Mexico S. de R.L de C.V [Lake Region Medical] | NEUROTHERM | 2014-06-03 |
Venusa de Mexico S. de R.L de C.V [Lake Region Medical] | NEUROTHERM | 2014-06-03 |
LAKE REGION MEDICAL | MANDREL GUIDEWIRE | 2014-04-08 |
LAKE REGION MEDICAL | HYDROPHILIC COATED GUIDEWIRE | 2014-04-07 |
LAKE REGION MEDICAL | MANDREL GUIDEWIRE | 2014-03-27 |
Venusa de Mexico S. de R.L de C.V [Lake Region Medical] | Biosense Webster Inc | 2013-03-19 |
Venusa de Mexico S. de R.L de C.V [Lake Region Medical] | Biosense Webster Inc | 2013-03-19 |
Venusa de Mexico S. de R.L de C.V [Lake Region Medical] | Biosense Webster Inc | 2013-03-19 |
Venusa de Mexico S. de R.L de C.V [Lake Region Medical] | Biosense Webster Inc | 2013-03-19 |
LAKE REGION MEDICAL | OSTAVI HYDROPHILIC GUIDEWIRE | 2013-02-26 |
Venusa de Mexico S. de R.L de C.V [Lake Region Medical] | Covidien electrosurgical | 2013-02-21 |
Venusa de Mexico S. de R.L de C.V [Lake Region Medical] | Covidien | 2013-02-21 |
Venusa de Mexico S. de R.L de C.V [Lake Region Medical] | Covidien electrosurgical | 2013-02-21 |
Venusa de Mexico S. de R.L de C.V [Lake Region Medical] | Covidien electrosurgical | 2013-02-21 |
Venusa de Mexico S. de R.L de C.V [Lake Region Medical] | Covidien electrosurgical | 2013-02-21 |
Lake Region Medical | Surefire High Flow Angiographic Catheter | 2013-01-17 |
Venusa de Mexico S. de R.L de C.V [Lake Region Medical] | BOSTON SCIENTIFIC | 2013-01-11 |
Venusa de Mexico S. de R.L de C.V [Lake Region Medical] | SMITH & NEPHEW INC., ENDOSCOPY DIVISION | 2012-02-21 |
Venusa de Mexico S. de R.L de C.V [Lake Region Medical] | SMITH & NEPHEW INC., ENDOSCOPY DIVISION | 2012-02-21 |
Venusa de Mexico S. de R.L de C.V [Lake Region Medical] | SMITH & NEPHEW INC., ENDOSCOPY DIVISION | 2012-02-21 |
Venusa de Mexico S. de R.L de C.V [Lake Region Medical] | SMITH & NEPHEW INC., ENDOSCOPY DIVISION | 2012-02-21 |
Venusa de Mexico S. de R.L de C.V [Lake Region Medical] | SMITH & NEPHEW INC., ENDOSCOPY DIVISION | 2012-02-21 |
Venusa de Mexico S. de R.L de C.V [Lake Region Medical] | SMITH & NEPHEW INC., ENDOSCOPY DIVISION | 2012-02-21 |
Venusa de Mexico S. de R.L de C.V [Lake Region Medical] | SMITH & NEPHEW INC., ENDOSCOPY DIVISION | 2012-02-21 |
Venusa de Mexico S. de R.L de C.V [Lake Region Medical] | SMITH & NEPHEW INC., ENDOSCOPY DIVISION | 2012-02-21 |
Venusa de Mexico S. de R.L de C.V [Lake Region Medical] | SMITH & NEPHEW INC., ENDOSCOPY DIVISION | 2012-02-21 |
Venusa de Mexico S. de R.L de C.V [Lake Region Medical] | SMITH AND NEPHEW ENDOSCOPY | 2012-02-21 |
Venusa de Mexico S. de R.L de C.V [Lake Region Medical] | SMITH AND NEPHEW ENDOSCOPY | 2012-02-21 |
LAKE REGION MEDICAL | HI TORQUE CONNECT GUIDEWIRE | 2011-11-03 |
LAKE REGION MEDICAL | ANCHORWIRE GUIDEWIRE | 2011-08-02 |
Venusa de Mexico S. de R.L de C.V [Lake Region Medical] | KCI USA, INC. (KINETIC CONCEPTS, INC.) | 2011-07-20 |
Venusa de Mexico S. de R.L de C.V [Lake Region Medical] | FUTURE MEDICAL SYSTEMS, INC | 2011-04-05 |
Venusa de Mexico S. de R.L de C.V [Lake Region Medical] | KCI USA, INC. (KINETIC CONCEPTS, INC.) | 2011-03-17 |
Venusa de Mexico S. de R.L de C.V [Lake Region Medical] | BOSTON SCIENTIFIC CORP | 2011-01-27 |
Venusa de Mexico S. de R.L de C.V [Lake Region Medical] | KCI USA, INC. (KINETIC CONCEPTS, INC.) | 2011-01-20 |
Lake Region Medical | K935198 | 2009-02-05 |
Karen Anderson [Lake Region Medical] | K935198 | 2009-02-05 |
Lake Region Medical | GLADIATOR GUIDEWIRE | 2009-02-02 |
Lake Region Medical | K080144 | 2008-11-03 |
Karen Anderson [Lake Region Medical] | K080144 | 2008-11-03 |
Venusa de Mexico S. de R.L de C.V [Lake Region Medical] | VENUSA LTD. | 2008-08-01 |
Venusa de Mexico S. de R.L de C.V [Lake Region Medical] | NEO HANDLE | 2008-08-01 |
Venusa de Mexico S. de R.L de C.V [Lake Region Medical] | EN BLOC Biopsy System | 2008-08-01 |
Venusa de Mexico S. de R.L de C.V [Lake Region Medical] | BLES HANDLE | 2008-08-01 |
Venusa de Mexico S. de R.L de C.V [Lake Region Medical] | NEO HANDLE | 2008-08-01 |
Venusa de Mexico S. de R.L de C.V [Lake Region Medical] | EN BLOC Biopsy System | 2008-08-01 |
Venusa de Mexico S. de R.L de C.V [Lake Region Medical] | BLES HANDLE | 2008-08-01 |
LAKE REGION MEDICAL | MANDREL GUIDEWIRES OR M-WIRE | 2008-03-21 |
Venusa de Mexico S. de R.L de C.V [Lake Region Medical] | OnePort Surgical Trocar System | 2008-01-08 |
Venusa de Mexico S. de R.L de C.V [Lake Region Medical] | Prolieve Thermodilatation System | 2007-12-27 |
Venusa de Mexico S. de R.L de C.V [Lake Region Medical] | Dendreon Corporation | 2007-12-27 |
Karen Anderson [Lake Region Medical] | K970376 | 2007-12-05 |
Lake Region Medical | K935170 | 2007-12-05 |
Karen Anderson [Lake Region Medical] | K935170 | 2007-12-05 |
Lake Region Medical | K914138 | 2007-12-05 |
Lake Region Medical | Torque Device | 2007-12-05 |
Karen Anderson [Lake Region Medical] | Torque Device | 2007-12-05 |
Lake Region Medical | K850829 | 2007-12-05 |
Karen Anderson [Lake Region Medical] | K850829 | 2007-12-05 |
Lake Region Medical | K770977 | 2007-12-05 |
Karen Anderson [Lake Region Medical] | K770977 | 2007-12-05 |
Lake Region Medical | K011968 | 2007-12-05 |
Lake Region Medical | K000011 | 2007-12-05 |
Venusa de Mexico S. de R.L de C.V [Lake Region Medical] | SMITH | 2006-10-26 |
Venusa de Mexico S. de R.L de C.V [Lake Region Medical] | NEPHEW RF DENERVATION PROBES | 2006-10-26 |
Venusa de Mexico S. de R.L de C.V [Lake Region Medical] | SMITH | 2006-10-26 |
Venusa de Mexico S. de R.L de C.V [Lake Region Medical] | NEPHEW RF DENERVATION PROBES | 2006-10-26 |
Venusa de Mexico S. de R.L de C.V [Lake Region Medical] | ELECTROSURGICAL ELECTROBLADE | 2006-09-28 |
Venusa de Mexico S. de R.L de C.V [Lake Region Medical] | SMITH | 2006-09-28 |
Venusa de Mexico S. de R.L de C.V [Lake Region Medical] | NEPHEW CDS SYSTEM | 2006-09-28 |
Venusa de Mexico S. de R.L de C.V [Lake Region Medical] | STONE CONE(TM) NITINOL U | 2005-10-25 |
Venusa de Mexico S. de R.L de C.V [Lake Region Medical] | ORATEC SPINECATH I | 2005-05-18 |
Import ID | Shipment | Cargo Description | Quantity |
---|---|---|---|
2020092668033 | Genova,Italy -> New York/Newark Area, Newark, New Jersey | PLASTIC COMPONENTS FOR MEDICAL USE HTS 90189085HTS | 1 PCS |
2020090226144 | Anvers,Belgium -> Los Angeles, California | MEDICAL DEVICES FOR SURGICAL USE | 28 PKG |
2020090226144 | Anvers,Belgium -> Los Angeles, California | MEDICAL DEVICES FOR SURGICAL USE | 28 PKG |
202008256383 | Anvers,Belgium -> Los Angeles, California | MEDICAL DEVICES FOR SURGICAL USE | 28 PKG |
202008256383 | Anvers,Belgium -> Los Angeles, California | MEDICAL DEVICES FOR SURGICAL USE | 28 PKG |
2020081226532 | Anvers,Belgium -> Los Angeles, California | MEDICAL DEVICES FOR SURGICAL USE | 28 PKG |
2020081226532 | Anvers,Belgium -> Los Angeles, California | MEDICAL DEVICES FOR SURGICAL USE | 28 PKG |
2020081128193 | Anvers,Belgium -> Los Angeles, California | MEDICAL DEVICES FOR SURGICAL USE | 28 PKG |
2020081128193 | Anvers,Belgium -> Los Angeles, California | MEDICAL DEVICES FOR SURGICAL USE | 28 PKG |
2020072956800 | Hong Kong,Hong Kong -> Long Beach, California | MEDICAL CABLETARIFF CODE 8544421900AS PER PACKING LIST CM202006467HS CODE 8544421900THIS SHIPMENT DOES NOT CONTAIN WOOD PACKAGING MATERIALS | 37 CTN |
2020071758317 | Anvers,Belgium -> New York/Newark Area, Newark, New Jersey | MEDICAL DEVICES FOR SURGICAL USE | 18 PKG |
2020071758317 | Anvers,Belgium -> New York/Newark Area, Newark, New Jersey | MEDICAL DEVICES FOR SURGICAL USE | 18 PKG |
202007144661 | Anvers,Belgium -> Los Angeles, California | MEDICAL DEVICES FOR SURGICAL USE | 34 PKG |
202007144661 | Anvers,Belgium -> Los Angeles, California | MEDICAL DEVICES FOR SURGICAL USE | 34 PKG |
202007144661 | Anvers,Belgium -> Los Angeles, California | MEDICAL DEVICES FOR SURGICAL USE | 34 PKG |