E-Z-EM, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
2411512	2411512	E-Z-EM, INC.	1	N	2026-01-01	510 Carnegie Center Princeton NJ US 08540

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
6839	1087793242	K921738	SONO-VU US(TM), MODIFICATION	HIO	1992-04-27
6839	1562773217	K883609	ACCES. PACKAGE FOR USE W/CARDIOGEN-82 GENERATOR	FRN	1989-04-14
6839	1145425689	K842568	RADIONUCLIDE INFUSION SYSTEM	FRN	1984-10-19
6839	1284042777	K181343	HeartSee Cardiac P.E.T. Processing Software	KPS	2018-06-12
6839	1199163277	K132192	BRACCO DIAGNOSTICS INC. PROTOCO, L TOUCH COLON INSUFFLATOR	FCX	2014-02-14
6839	1746262530	K030854	PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400	FCX	2003-04-16
6839	1050706900
6839	1205300138
6839	1311811241
6839	1334588927
6839	1745407789
6839	1755095345
6839	1838698283

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
FCX	2	2014-02-14
FRN	2	1989-04-14
KPS	1	2018-06-12
HIO	1	1992-04-27

NDC#

E-Z-Disk
E-Z-EM, INC.
barium sulfate
E-Z-GAS
E-Z-EM, INC.
Antacid/AntiFlatulent

PMN#

MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIES
2007-06-13
E-Z-EM, INC.
EMPOWERMR INJECTOR SYSTEM, MODEL 9730
2007-04-13
E-Z-EM, INC.
EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900
2006-11-02
E-Z-EM, INC.
E-Z-EM ENDOSCOPIC CO2 REGULATOR
2005-12-27
E-Z-EM, INC.
EMPOWER TRANSFER SET, (CAT. NO. 7725)
2004-07-16
E-Z-EM, INC.
EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825
2003-06-19
E-Z-EM, INC.
PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400
2003-04-16
E-Z-EM, INC.
PROTOCO2L INSUFFLATOR MODEL 6400
2002-02-19
E-Z-EM, INC.
E-Z EM PERCUPUMP 2001 CT INJECTOR
2001-05-16
E-Z-EM, INC.
PERCUPUMP II WITH EDA
1998-01-27
E-Z-EM, INC.
PERCUPUMP II WITH EDA
1997-01-23
E-Z-EM, INC.
HM-CAP CONTROL PANEL
1996-01-30
E-Z-EM, INC.
PERCUPUMP II
1995-03-21
E-Z-EM, INC.
E-Z-FLATE
1994-07-01
E-Z-EM, INC.
E-Z-EM ENTEROCLYSIS CATHETER SET
1992-11-16
E-Z-EM, INC.
HIGH PRESSURE CONNECTING SETS, MODIFICATION
1992-05-20
E-Z-EM, INC.
GUIDE WIRES, MODIFICATION
1992-05-20
E-Z-EM, INC.
E-Z-FLOW ANGIOGRAPHY CATHETERS, MODIFICATION
1992-05-20
E-Z-EM, INC.
SONO-VU US(TM), MODIFICATION
1992-04-27
E-Z-EM, INC.
PERCUGUIDE LESION MARKING
1992-04-21
E-Z-EM, INC.
ANGIOGRAPHIC FLUSH SYSTEM
1992-01-22
E-Z-EM, INC.
ANGIODYNAMICS ANGIOFILL FLUID MANAGEMENT SYSTEM
1992-01-09
E-Z-EM, INC.
SOS BLOODLESS NEEDLE
1991-12-20
E-Z-EM, INC.
DISPOSABLE ANGIOGRAPHY NEEDLE, MODIFICATION
1991-12-20
E-Z-EM, INC.
ANGIOGRAPHIC SOFT TIP CATHETER
1991-12-18
E-Z-EM, INC.
GASPARAITIS ESOPHAGRAM CATHETER SET
1991-07-24
E-Z-EM, INC.
SONO-VU US(TM)
1991-06-24
E-Z-EM, INC.
EIA FOR DETECTION OF ANTIBODIES H. PYLORI
1991-06-10
E-Z-EM, INC.
E-Z-EM PULSED INFUSION SYSTEM
1991-04-01
E-Z-EM, INC.
SLIM LINE RETENTION TIP W/ SILICONE RUBBER CUFF
1991-01-24
E-Z-EM, INC.
SLIM LINE RETENT TIP W/SILICONE INFLATION CUFF
1990-11-27
E-Z-EM, INC.
PERCU-SET(TM)
1990-03-29
E-Z-EM, INC.
E-Z-EM VACUUM ASPIRATION SYRINGE
1989-12-27
E-Z-EM, INC.
INTERVENTIONAL PRODUCTS - GUIDE WIRES
1989-05-31
E-Z-EM, INC.
HIGH PRESSURE CONNECTING SETS
1989-05-19
E-Z-EM, INC.
E-Z-FLOW ANGIOGRAPHY CATHETERS
1989-05-19
E-Z-EM, INC.
DISPOSABLE ANGIOGRAPHY NEEDLES
1989-05-19
E-Z-EM, INC.
WINGED INFUSION SET
1989-01-31
E-Z-EM, INC.
E-Z-EM(R) LUFKIN BIOPSY NEEDLES
1988-07-25
E-Z-EM, INC.
PERCUPUMP (TM)
1987-01-16
E-Z-EM, INC.

56 records. Showing 1-40. Next