Company · US

E-Z-Em, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 2007. Name variants (Inc, Corp, punctuation) are merged.

56510(k) clearances (0 in 12 months)

3recalls (0 in 12 months)

3recalls that name a 510(k)

Product codes

Code	Device	Records
JAK	System, X-Ray, Tomography, Computed	6
FCX	Insufflator, Automatic Carbon-Dioxide For Endoscope	4
FPA	Set, Administration, Intravascular	3
HIO	Sampler, Amniotic Fluid (Amniocentesis Tray)	3
KNT	Tubes, Gastrointestinal (And Accessories)	3
DQO	Catheter, Intravascular, Diagnostic	2
DQX	Wire, Guide, Catheter	2
DRC	Trocar	2
DSB	Plethysmograph, Impedance	2
FGD	Catheter, Retention, Barium Enema With Bag	2
GDF	Guide, Needle, Surgical	2
IZQ	Injector, Contrast Medium, Automatic	2
KXZ	System, Thermographic, Liquid Crystal, Powered (Adjunctive Use)	2
LJE	Catheter, Nephrostomy	2
LYR	Helicobacter Pylori	2
BYP	Mouthpiece, Breathing	1
DQY	Catheter, Percutaneous	1
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	1
DXT	Injector And Syringe, Angiographic	1
DYB	Introducer, Catheter	1

Latest 510(k) clearances

Decided	510(k)	Device and applicant	Code
Jun 13, 2007	K071378	MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIES E-Z-Em, Inc.	JAK
Apr 13, 2007	K062449	EMPOWERMR INJECTOR SYSTEM, MODEL 9730 E-Z-Em, Inc.	IZQ
Nov 2, 2006	K063029	EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900 E-Z-Em, Inc.	JAK
Dec 27, 2005	K053008	E-Z-EM ENDOSCOPIC CO2 REGULATOR E-Z-Em, Inc.	FCX
Jul 16, 2004	K041178	EMPOWER TRANSFER SET, (CAT. NO. 7725) E-Z-Em, Inc.	FPK
Jun 19, 2003	K031571	EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825 E-Z-Em, Inc.	IZQ
Apr 16, 2003	K030854	PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400 E-Z-Em, Inc.	FCX
Feb 19, 2002	K013219	PROTOCO2L INSUFFLATOR MODEL 6400 E-Z-Em, Inc.	FCX
May 16, 2001	K011160	E-Z EM PERCUPUMP 2001 CT INJECTOR E-Z-Em, Inc.	JAK
Jan 27, 1998	K974621	PERCUPUMP II WITH EDA E-Z-Em, Inc.	DSB
Jan 23, 1997	K961845	PERCUPUMP II WITH EDA E-Z-Em, Inc.	DSB
Jan 30, 1996	K954926	HM-CAP CONTROL PANEL E-Z-Em, Inc.	LYR
Mar 21, 1995	K932055	PERCUPUMP II E-Z-Em, Inc.	FIH
Jul 1, 1994	K930581	E-Z-FLATE E-Z-Em, Inc.	FCX
Nov 16, 1992	K911349	E-Z-EM ENTEROCLYSIS CATHETER SET E-Z-Em, Inc.	EZK
May 20, 1992	K914987	HIGH PRESSURE CONNECTING SETS, MODIFICATION E-Z-Em, Inc.	DTL
May 20, 1992	K914986	GUIDE WIRES, MODIFICATION E-Z-Em, Inc.	DQX
May 20, 1992	K914984	E-Z-FLOW ANGIOGRAPHY CATHETERS, MODIFICATION E-Z-Em, Inc.	DQY
Apr 27, 1992	K921738	SONO-VU US(TM), MODIFICATION E-Z-Em, Inc.	HIO
Apr 21, 1992	K920816	PERCUGUIDE LESION MARKING E-Z-Em, Inc.	GDF
Jan 22, 1992	K914113	ANGIOGRAPHIC FLUSH SYSTEM E-Z-Em, Inc.	FPA
Jan 9, 1992	K914026	ANGIODYNAMICS ANGIOFILL FLUID MANAGEMENT SYSTEM E-Z-Em, Inc.	FPA
Dec 20, 1991	K914985	DISPOSABLE ANGIOGRAPHY NEEDLE, MODIFICATION E-Z-Em, Inc.	DRC
Dec 20, 1991	K914330	SOS BLOODLESS NEEDLE E-Z-Em, Inc.	DYB
Dec 18, 1991	K914199	ANGIOGRAPHIC SOFT TIP CATHETER E-Z-Em, Inc.	DQO
Jul 24, 1991	K911897	GASPARAITIS ESOPHAGRAM CATHETER SET E-Z-Em, Inc.	KNT
Jun 24, 1991	K904583	SONO-VU US(TM) E-Z-Em, Inc.	HIO
Jun 10, 1991	K905409	EIA FOR DETECTION OF ANTIBODIES H. PYLORI E-Z-Em, Inc.	LYR
Apr 1, 1991	K905447	E-Z-EM PULSED INFUSION SYSTEM E-Z-Em, Inc.	KRA
Jan 24, 1991	K905574	SLIM LINE RETENTION TIP W/ SILICONE RUBBER CUFF E-Z-Em, Inc.	FGD
Nov 27, 1990	K904299	SLIM LINE RETENT TIP W/SILICONE INFLATION CUFF E-Z-Em, Inc.	FGD
Mar 29, 1990	K900021	PERCU-SET(TM) E-Z-Em, Inc.	HIO
Dec 27, 1989	K895012	E-Z-EM VACUUM ASPIRATION SYRINGE E-Z-Em, Inc.	GAA
May 31, 1989	K890207	INTERVENTIONAL PRODUCTS - GUIDE WIRES E-Z-Em, Inc.	DQX
May 19, 1989	K890209	DISPOSABLE ANGIOGRAPHY NEEDLES E-Z-Em, Inc.	DRC
May 19, 1989	K890208	HIGH PRESSURE CONNECTING SETS E-Z-Em, Inc.	DXT
May 19, 1989	K890206	E-Z-FLOW ANGIOGRAPHY CATHETERS E-Z-Em, Inc.	DQO
Jan 31, 1989	K885264	WINGED INFUSION SET E-Z-Em, Inc.	FPA
Jul 25, 1988	K882601	E-Z-EM(R) LUFKIN BIOPSY NEEDLES E-Z-Em, Inc.	GDM
Jan 16, 1987	K864227	PERCUPUMP (TM) E-Z-Em, Inc.	FRN
Aug 29, 1986	K863090	PERCU GUIDE I (LOOP TYPE) E-Z-Em, Inc.	GDF
Dec 18, 1985	K853667	BRONCHIAL CYTOLOGY BRUSH E-Z-Em, Inc.
Nov 15, 1985	K854248	GOODLEY POLYAXIAL CERVICAL TRACTION UNIT E-Z-Em, Inc.
Nov 5, 1985	K853666	ENDODYNAMICS SIEGEL THERAPUTIC STENT E-Z-Em, Inc.	FGE
Nov 5, 1985	K853384	E-Z-EM GASTRIC LAVAGE CATHETER E-Z-Em, Inc.	KNT
Nov 4, 1985	K853680	ENDODYNAMIC SIEGEL SPHINCTEROTOME E-Z-Em, Inc.	KNS
Oct 23, 1985	K853402	E-Z-GUARD MOUTHPIECE E-Z-Em, Inc.	BYP
Oct 4, 1985	K853530	ENDO DYNAMICS GASTROINTESTINAL CYTOLOGY BRUSH E-Z-Em, Inc.	FDX
Oct 1, 1984	K842121	E-Z-EM SINGLE STICK PUNCTURE/DRAINAGE E-Z-Em, Inc.	LJE
Jul 26, 1984	K841720	E-Z-EM PERCUTANEOUS NEPHROSTOMY SETS E-Z-Em, Inc.	LJE

Newest 50 of 56.

Latest recalls

Date	Firm and product	Code	Linked 510(k)
Feb 16, 2005	E-Z-EM, Inc Brand Name of Device: EmpowerCT/EmpowerCTA Injector System Ceiling Column Accessory; Common/Usual Name: CT Injector System Ceiling Column Accessory, Catalog Number 9886L. Ceiling Column Accessory: T Terminated	JAK	K011160 K031571
Feb 16, 2005	E-Z-EM, Inc Brand Name: EmpowerCT/EmpowerCTA Injector System Ceiling Column Accessory; Common/Usual Name: CT Injector System Ceiling Column Accessory, Catalog Number 9886M. Ceiling Column Accessory: The CT and Terminated	JAK	K011160 K031571
Feb 16, 2005	E-Z-EM, Inc Brand Name: EmpowerCT/EmpowerCTA Injector System Ceiling Column Accessory; Common/Usual Name: CT Injector System Ceiling Column Accessory, Catalog Number 9886S. Ceiling Column Accessory: The CT and Terminated	JAK	K011160 K031571

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