Numed Inc

FDA Filings

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

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

FDA Registration(s)
Registration Number1318694
FEI Number1318694
NameNUMED, INC.
Owner & OperatorNUMED, INC.
Contact Address2880 MAIN ST. --
HOPKINTON NY 12965 US
Official Correspondent
  • NICHELLE R LAFLESH
  • x-315-3284491-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address2880 MAIN ST.
Hopkinton, NY 12965 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Device in the United States for Export Only
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Owner/Operator Registration

FDA Filings

Device
Company
DeviceDate
NuMED Inc.
BIB Stent Placement Catheter2022-01-12
NUMED, INC.
 G-Armor Stent, G-Armor Covered Stent, G-Armor Mounted Stent, G-Armor Covered Mounted Stent2021-12-13
NUMED, INC.
 NuDEL Delivery System2021-07-28
NuMED, Inc.
Z-6 Atrioseptostomy Catheter2021-07-19
NuMED, Inc
BIB Stent Placement Catheter2021-05-27
NUMED, INC.
 CP Stent, Covered CP Stent, Mounted CP Stent, Covered and Mounted CP Stent, Mounted CP Stent, NuDEL2019-12-19
NuMED, Inc.
D'Vill Introducer2019-05-14
NUMED, INC.
 REBOA Catheter RB4020702019-03-21
NUMED, INC.
 REBOA Catheter RB4020502019-03-21
NUMED, INC.
 REBOA Catheter RB4020302019-03-21
NUMED, INC.
 REBOA Catheter RB4010702019-03-21
NUMED, INC.
 REBOA Catheter RB4010502019-03-21
NUMED, INC.
 REBOA Catheter RB4010302019-03-21
NUMED, INC.
 REBOA Catheter RB3520702019-03-21
NUMED, INC.
 REBOA Catheter RB3520502019-03-21
NUMED, INC.
 REBOA Catheter RB3520302019-03-21
NUMED, INC.
 REBOA Catheter RB3510702019-03-21
NUMED, INC.
 REBOA Catheter RB3510502019-03-21
NUMED, INC.
 REBOA Catheter RB3510302019-03-21
NUMED, INC.
 REBOA Catheter RB3020702019-03-21
NUMED, INC.
 REBOA Catheter RB3020502019-03-21
NUMED, INC.
 REBOA Catheter RB3020302019-03-21
NUMED, INC.
 REBOA Catheter RB3010702019-03-21
NUMED, INC.
 REBOA Catheter RB3010502019-03-21
NUMED, INC.
 REBOA Catheter RB3010302019-03-21
NUMED, INC.
 REBOA Catheter RB2520702019-03-21
NUMED, INC.
 REBOA Catheter RB2520502019-03-21
NUMED, INC.
 REBOA Catheter RB2520302019-03-21
NUMED, INC.
 REBOA Catheter RB2510702019-03-21
NUMED, INC.
 REBOA Catheter RB2510502019-03-21
NUMED, INC.
 REBOA Catheter RB2510302019-03-21
NUMED, INC.
 REBOA Catheter RB2020702019-03-21
NUMED, INC.
 REBOA Catheter RB2020502019-03-21
NUMED, INC.
 REBOA Catheter RB2010702019-03-21
NUMED, INC.
 REBOA Catheter RB2010502019-03-21
NUMED, INC.
 REBOA Catheter RB2010302019-03-21
NUMED, INC.
 REBOA Catheter RB1520702019-03-21
NUMED, INC.
 REBOA Catheter RB1520502019-03-21
NUMED, INC.
 REBOA Catheter RB1520302019-03-21
NUMED, INC.
 REBOA Catheter RB1510702019-03-21
NUMED, INC.
 REBOA Catheter RB1510502019-03-21
NUMED, INC.
 REBOA Catheter RB1510302019-03-21
NUMED, INC.
 REBOA Catheter RB4040702019-03-21
NUMED, INC.
 REBOA Catheter RB4040502019-03-21
NUMED, INC.
 REBOA Catheter RB4040302019-03-21
NUMED, INC.
 REBOA Catheter RB4030702019-03-21
NUMED, INC.
 REBOA Catheter RB4030502019-03-21
NUMED, INC.
 REBOA Catheter RB4030302019-03-21
NUMED, INC.
 REBOA Catheter RB3540702019-03-21
NUMED, INC.
 REBOA Catheter RB3540502019-03-21
NUMED, INC.
 REBOA Catheter RB3540302019-03-21
NUMED, INC.
 REBOA Catheter RB3530702019-03-21
NUMED, INC.
 REBOA Catheter RB3530502019-03-21
NUMED, INC.
 REBOA Catheter RB3530302019-03-21
NUMED, INC.
 REBOA Catheter RB3040702019-03-21
NUMED, INC.
 REBOA Catheter RB3040502019-03-21
NUMED, INC.
 REBOA Catheter RB3040302019-03-21
NUMED, INC.
 REBOA Catheter RB3030702019-03-21
NUMED, INC.
 REBOA Catheter RB3030502019-03-21
NUMED, INC.
 REBOA Catheter RB3030302019-03-21
NUMED, INC.
 REBOA Catheter RB2540702019-03-21
NUMED, INC.
 REBOA Catheter RB2540502019-03-21
NUMED, INC.
 REBOA Catheter RB2540302019-03-21
NUMED, INC.
 REBOA Catheter RB2530702019-03-21
NUMED, INC.
 REBOA Catheter RB2530502019-03-21
NUMED, INC.
 REBOA Catheter RB2530302019-03-21
NUMED, INC.
 REBOA Catheter RB2040702019-03-21
NUMED, INC.
 REBOA Catheter RB2040502019-03-21
NUMED, INC.
 REBOA Catheter RB2040302019-03-21
NUMED, INC.
 REBOA Catheter RB2030702019-03-21
NUMED, INC.
 REBOA Catheter RB2030502019-03-21
NUMED, INC.
 REBOA Catheter RB2030302019-03-21
NUMED, INC.
 REBOA Catheter RB1540702019-03-21
NUMED, INC.
 REBOA Catheter RB1540502019-03-21
NUMED, INC.
 REBOA Catheter RB1540302019-03-21
NUMED, INC.
 REBOA Catheter RB1530702019-03-21
NUMED, INC.
 REBOA Catheter RB1530502019-03-21
NUMED, INC.
 REBOA Catheter RB1530302019-03-21
NUMED, INC.
 NuDel Delivery System2018-11-14
NUMED, INC.
 Cheatham Platinum (CP) Stent System (Covered CP Stent, Covered Mounted CP Stent, CP Stent, Mounted CP Stent)2018-07-20
NUMED, INC.
 REBOA Catheter RB2020302018-07-06
NUMED, INC.
 SF-NIH SF4602018-07-06
NUMED, INC.
 SF-NIH SF3602018-07-06
NUMED, INC.
 Tearduct Catheter TD1002018-03-29
NUMED, INC.
 Cheatham Platinum (CP) Stent System (Covered CP Stent, Covered Mounted CP Stent, CP Stent, Mounted CP Stent)2017-10-24
NUMED, INC.
D'Vill2017-10-23
NuMED, Inc.
D'Vill Introducer2017-10-20
NUMED, INC.
BIB Stent Placement Catheter2016-09-22
NUMED, INC.
BIB Stent Placement Catheter2016-09-22
NUMED, INC.
REBOA2016-09-15
NUMED, INC.
BIB Stent Placement Catheter2016-07-27
NUMED, INC.
REBOA Balloon Catheter2016-06-20
NUMED, INC.
BIB Stent Placement Catheter2016-05-20
NUMED, INC.
NuDEL2016-03-28
NUMED, INC.
Mounted CP Stent2016-03-28
NUMED, INC.
Covered Mounted CP Stent2016-03-28
NUMED, INC.
Covered CP Stent2016-03-28
NUMED, INC.
CP Stent2016-03-28
NUMED, INC.
 CHEATHAM PLATINUM (CP) STENT SYSTEM (Covered CP Stent, Covered Mounted CP Stent, CP Stent, Mounted CP Stent)2016-03-25
NUMED, INC.
NuDEL2015-03-13
NUMED, INC.
BIB Stent Placement Catheter2015-03-13
NUMED, INC.
RESPC2015-02-25
NUMED, INC.
MTK2015-02-25
NUMED, INC.
Bonhoeffer Mitral Kit2015-02-25
NUMED, INC.
DSC2015-02-25
NUMED, INC.
DS2015-02-25
NUMED, INC.
Jomiva2015-02-25
NUMED, INC.
High Five2015-02-25
NUMED, INC.
DHC2015-02-25
NUMED, INC.
DH2015-02-25
NUMED, INC.
ASD2015-02-25
NUMED, INC.
Ensemble? Transcatheter Valve Delivery System2015-02-13
NUMED, INC.
Ensemble? II Transcatheter Valve Delivery System2015-02-13
NUMED, INC.
PTS-X SIZING BALLOON CATHETER2013-08-08
NUMED, INC.
Ensemble HDE2012-10-16
NUMED, INC.
Ensemble HDE2012-10-16
NUMED, INC.
Ensemble HDE2012-10-16
NUMED, INC.
Ensemble HDE2012-10-16
NUMED, INC.
Ensemble HDE2012-10-16
NUMED, INC.
Z-MED2012-10-10
NUMED, INC.
Z-MED II2012-10-10
NUMED, INC.
Tyshak NuCLEUS2012-10-10
NUMED, INC.
NuCLEUS2012-10-10
NUMED, INC.
NuCLEUS-X2012-10-10
NUMED, INC.
Z-MED Z-MED II2012-10-04
NUMED, INC.
TYSHAK NUCLEUS2012-08-31
NUMED, INC.
NUCLEUS-X PTV CATHETER2012-06-11
NUMED, INC.
PTS-X SIZING BALLOON CATHETER2011-04-29
NUMED, INC.
MULLINS-X PTV CATHETER2010-12-09
NUMED, INC.
MULLINS-X, MODEL 250X2008-10-24
NUMED, INC.
MINI GHOST, MODEL: 5072008-09-26
NUMED, INC.
Bonhoeffer Mitral Valve Kit2008-09-04
NUMED, INC.
EP Catheter2008-09-04
NUMED, INC.
NuCLEUS-X2008-07-18
NUMED, INC.
NUCLEUS-X, MODEL 230X2008-07-10
NUMED, INC.
Z-MED2007-10-09
NUMED, INC.
Impact2007-10-09
NUMED, INC.
Atrioseptostomy2007-10-09
NUMED, INC.
Multi-Track2007-10-09
NUMED, INC.
Impact2007-10-09
NUMED, INC.
Ghost, Tyshak & Z-MED2007-10-09
NUMED, INC.
PTS-X2007-10-09
NUMED, INC.
Mullins-X2007-10-09
NUMED, INC.
Tyshak II & Z-MED II2007-10-09
NUMED, INC.
X-line Catheters2007-10-09
NUMED, INC.
COEfficient2007-10-09
NUMED, INC.
Mullins2007-10-09
NUMED, INC.
Marauder2007-10-09
NUMED, INC.
Marauder2007-10-09
NUMED, INC.
Ghost II2007-10-09
NUMED, INC.
Ghost II2007-10-09
NUMED, INC.
PTS2007-10-09
NUMED, INC.
Tyshak Mini2007-10-09
NUMED, INC.
Tyshak Mini2007-10-09
NUMED, INC.
Tyshak & Z-MED2007-10-09
NUMED, INC.
Tyshak & Z-MED2007-10-09
NUMED, INC.
Tyshak II & Z-MED II2007-10-09
NUMED, INC.
BIB CATHETER2006-05-24
NUMED, INC.
TEARDUCT CATHETER2006-05-24
NUMED, INC.
MINI GHOST PTA CATHETER, MODEL 5072005-07-28
NUMED, INC.
BIB PTA BALLOON CATHETER2005-07-28
NUMED, INC.
PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS2004-06-18
NUMED, INC.
NUMED PTS X SIZING BALLOON CATHETER2004-06-10
NUMED, INC.
NUMED MULLINS X PTA CATHETER2004-05-06
NUMED, INC.
NUMED TYSHAK MINI PEDIATRIC PTV CATHETER2003-09-25
NUMED, INC.
MODIFICATION TO NUMED TYSHAK II AND Z-MED II PTV CATHETERS2003-05-21
NUMED, INC.
PTA AND PTV2002-09-13
NUMED, INC.
NUMED COEFFICIENT PTV CATHETERS2002-01-16
NUMED, INC.
NUMED MULLINS PTA CATHETER2002-01-03
NUMED, INC.
PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS2001-07-12
NUMED, INC.
PTA-OS SIZING BALLOON, MODEL 3602001-05-02
NUMED, INC.
NUMED HIGH PRESSURE PTA CATHETERS2001-04-20
NUMED, INC.
NUMED GHOST II PTA CATHETERS2001-01-11
NUMED, INC.
MULTITRACK ANGIOGRAPHIC CATHETER2001-01-11
NUMED, INC.
NUMED Z-MED PTV CATHERERS2000-12-27
NUMED, INC.
TYSHAK MINI PEDIATRIC PTV CATHETER, MODEL 1072000-12-01
NUMED, INC.
NUMED TYSHAK AND Z-MED PTV CATHETERS2000-11-01
NUMED, INC.
NUMED TYSHAK II AND Z-MED II PTV CATHETERS2000-11-01
NUMED, INC.
TYSHAK, MODEL 102 AND Z-MED, MODEL 3022000-09-27
NUMED, INC.
NUMED Z-5 ATRIOSEPTOSTOMY CATHETER2000-07-12
NUMED, INC.
NUMED ATRIOSEPTOSTOMY CATHETER1996-04-02
NUMED, INC.
TYSHAK PERIPHERAL BALLOON DILATION CATHETER1993-12-21
NUMED, INC.
MINI GHOST CATHETER1992-07-07
NUMED, INC.
MODIFIED NUMED BALLOON ANGIOGRAPHIC CATHETER1989-04-21
NUMED, INC.
NUMED BALLOON THERMODILUTION CATHETER1988-09-06
NUMED, INC.
NUMED PTA CATHETERS1987-12-03
NUMED, INC.
NUMED BALLOON WEDGE PRESSURE CATHETER1987-02-20
NUMED, INC.
NUMED BALLOON ANGIOGRAPHIC CATHETERS1987-02-19
NUMED, INC.
INTRAVASCULAR CATHETER W/DOPPLER TRANSDUCER1986-06-02
NUMED, INC.
NUMED TEMP. STYLET PACING PAROBE 13186941985-08-29
NUMED, INC.
NUMED BALLOON PACING CATHETER1985-04-19
NUMED, INC.
NUMED BALLOON PACING CATHETER1985-01-14

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