NUMED, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1318694	1318694	NUMED, INC.	1	Y	2026-01-01	2880 MAIN ST. Hopkinton NY US 12965
9618000	3003245778	NUMED CANADA, INC.	1	N	2026-01-01	45 Second Street West CORNWALL Ontario CA K6J 1G3
3008494514	3008494514	NUMEDIS INC.	1	N	2020-04-25	2 ENTERPRISE AVE NE STE A2 Isanti MN US 55040
3009505478	3009505478	NuMed Industries, LLC.	1	Y	2020-04-25	1240 Tangelo Terrace B1/B24 Delray Beach FL US 33444
3013742844	3013742844	NUMEDICO TECHNOLOGIES PTY LTD	1	N	2020-04-25	Unit 2 21 Jenkins Ave Myrtle Bank South Australia AU 5064

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
2004	1494197278	P150028	CHEATHAM PLATINUM (CP) STENT SYSTEM (Covered CP Stent, Covered Mounted CP Stent, CP Stent, Mounted CP Stent)	PNF	2016-03-25
19761	1908373024	P150028	CHEATHAM PLATINUM (CP) STENT SYSTEM (Covered CP Stent, Covered Mounted CP Stent, CP Stent, Mounted CP Stent)	PNF	2016-03-25
19761	1728525451	K991977	TYSHAK, MODEL 102 AND Z-MED, MODEL 302	LIT	2000-09-27
2004	1859529272	K991977	TYSHAK, MODEL 102 AND Z-MED, MODEL 302	LIT	2000-09-27
2004	1755792568	K983373	IMPACT BALLOON DILATION CATHETER	KNQ	1999-06-22
19761	1445056226	K960070	NUMED ATRIOSEPTOSTOMY CATHETER	DQO	1996-04-02
2004	1719521954	K960070	NUMED ATRIOSEPTOSTOMY CATHETER	DQO	1996-04-02
2004	1519503200	K952984	MAP MULTITRACK ANGIOGRAPHIC CATHETER (4F)	DQO	1996-01-29
19761	1631501985	K952984	MAP MULTITRACK ANGIOGRAPHIC CATHETER (4F)	DQO	1996-01-29
19761	1135163527	K931009	TYSHAK PERIPHERAL BALLOON DILATION CATHETER	LIT	1993-12-21
2004	1790330182	K931009	TYSHAK PERIPHERAL BALLOON DILATION CATHETER	LIT	1993-12-21
139380	1409339230	K910944	MEDIFIL	KGN	1991-04-02
2004	1021064495	K211910	Z-6 Atrioseptostomy Catheter	DXF	2021-07-19
19761	1234592118	K211910	Z-6 Atrioseptostomy Catheter	DXF	2021-07-19
2004	1429724964	K211134	BIB Stent Placement Catheter	NVM	2021-05-27
2004	1252079005	K171206	D'Vill Introducer	DYB	2017-10-20
2004	1084423133	K161451	BIB Stent Placement Catheter	NVM	2016-09-22
2004	1052190528	K160889	BIB Stent Placement Catheter	NVM	2016-05-20
2004	1088558763	K160598	REBOA Balloon Catheter	MJN	2016-06-20
221657	1015103149	K141349	Disposable sterile needle retractable safety syringe	MEG	2015-04-10
139380	1686695845	K122325	SKINTEMP II	KGN	2012-10-26
2004	1213035725	K122012	Z-MED Z-MED II	OZT	2012-10-04
19761	1868791640	K122012	Z-MED Z-MED II	OZT	2012-10-04
2004	1151394979	K121859	TYSHAK NUCLEUS	DQY	2012-08-31
19761	2003815850	K121859	TYSHAK NUCLEUS	DQY	2012-08-31
19761	1318438115	K102473	MULLINS-X PTV CATHETER	OMZ	2010-12-09
19761	1112332836	K081680	NUCLEUS-X, MODEL 230X	DQY	2008-07-10
2004	1414877009	K081680	NUCLEUS-X, MODEL 230X	DQY	2008-07-10
139380	1481402299	K071442	SUPRASORB A +AG	FRO	2008-05-01
117418	1802966059	K063304	LIFE4C	LYX	2007-12-21
2004	1087704988	K051343	MINI GHOST PTA CATHETER, MODEL 507	DQY	2005-07-28
19761	1809839886	K051343	MINI GHOST PTA CATHETER, MODEL 507	DQY	2005-07-28
2004	1294466274	K050857	BIB PTA BALLOON CATHETER	NVM	2005-07-28
19761	1356918582	K041306	NUMED PTS X SIZING BALLOON CATHETER	MJN	2004-06-10
2004	1987252630	K041306	NUMED PTS X SIZING BALLOON CATHETER	MJN	2004-06-10
2004	1397217712	K041093	NUMED MULLINS X PTA CATHETER	DQY	2004-05-06
19761	1694596854	K041093	NUMED MULLINS X PTA CATHETER	DQY	2004-05-06
19761	1784356376	K032591	NUMED TYSHAK MINI PEDIATRIC PTV CATHETER	DQY	2003-09-25
19761	1278493554	K030589	MODIFICATION TO NUMED TYSHAK II AND Z-MED II PTV CATHETERS	DQY	2003-05-21
2004	1809661243	K030589	MODIFICATION TO NUMED TYSHAK II AND Z-MED II PTV CATHETERS	DQY	2003-05-21
2004	1678424371	K022722	PTA AND PTV	DQY	2002-09-13
19761	2023178077	K022722	PTA AND PTV	DQY	2002-09-13
2004	1083614136	K014124	NUMED COEFFICIENT PTV CATHETERS	OMZ	2002-01-16
19761	1198983520	K014124	NUMED COEFFICIENT PTV CATHETERS	OMZ	2002-01-16
2004	1591645555	K013601	NUMED MULLINS PTA CATHETER	DQY	2002-01-03
2004	1088920018	K010880	NUMED HIGH PRESSURE PTA CATHETERS	DQY	2001-04-20
19761	1002441735	K003972	NUMED GHOST II PTA CATHETERS	LIT	2001-01-11
2004	1292595755	K003972	NUMED GHOST II PTA CATHETERS	LIT	2001-01-11
19761	1339801576	K003320	PTA-OS SIZING BALLOON, MODEL 360	MJN	2001-05-02
2004	1729928817	K003320	PTA-OS SIZING BALLOON, MODEL 360	MJN	2001-05-02
2004	1676251394	K003276	TYSHAK MINI PEDIATRIC PTV CATHETER, MODEL 107	LIT	2000-12-01
19761	2012686354	K003276	TYSHAK MINI PEDIATRIC PTV CATHETER, MODEL 107	LIT	2000-12-01
2004	1256514036	K003114	NUMED TYSHAK AND Z-MED PTV CATHETERS	LIT	2000-11-01
19761	1522313916	K003052	NUMED TYSHAK II AND Z-MED II PTV CATHETERS	LIT	2000-11-01
2004	1716068041	K003052	NUMED TYSHAK II AND Z-MED II PTV CATHETERS	LIT	2000-11-01
2004	1264045259	H080002
2004	1233946165	DEN080015	NUCLEUS-X PTV CATHETER	OZT	2012-06-11
19761	1574273855	DEN080015	NUCLEUS-X PTV CATHETER	OZT	2012-06-11
139380	1005468955
2004	1150080296
2004	1350993334
139380	1356667214
19761	1774986059
19761	1804024266
2004	1868039335
2004	1875576981
139380	1894854695
2004	1917525125
19761	1929074162
19761	2028657236
2004	2047908118
2004	1490893466
2004	1975141127

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
DQY	15	2012-08-31
LIT	11	2001-01-11
MJN	5	2016-06-20
NVM	4	2021-05-27
OZT	4	2012-10-04
DQO	4	1996-04-02
OMZ	3	2010-12-09
DXF	2	2021-07-19
PNF	2	2016-03-25
KGN	2	2012-10-26
DYB	1	2017-10-20
MEG	1	2015-04-10
FRO	1	2008-05-01
LYX	1	2007-12-21
KNQ	1	1999-06-22