Medical Device Manufacturer · US , Mchenry , IL

E-Z-Em, Inc.

56 submissions · 56 cleared · Since 1977
56
Total
56
Cleared
0
Denied

E-Z-Em, Inc. — FDA 510(k) Submissions

E-Z-Em, Inc. has submitted 56 FDA 510(k) premarket notifications since 1977, of which 56 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Insufflator, Automatic Carbon-dioxide For Endoscope, Set, Administration, Intravascular, Tubes, Gastrointestinal (and Accessories), System, X-ray, Tomography, Computed, Sampler, Amniotic Fluid (amniocentesis Tray) . Use the specialty filter in the sidebar to narrow results.

56 devices
1–25 of 56
MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIES
K071378 · JAK System, X-ray,... · Radiology
Jun 2007 27d
EMPOWERMR INJECTOR SYSTEM, MODEL 9730
K062449 · IZQ Injector, Contrast... · Cardiovascular
Apr 2007 234d
EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900
K063029 · JAK System, X-ray,... · Radiology
Nov 2006 31d
E-Z-EM ENDOSCOPIC CO2 REGULATOR
K053008 · FCX Insufflator, Automatic... · Gastroenterology & Urology
Dec 2005 62d
EMPOWER TRANSFER SET, (CAT. NO. 7725)
K041178 · FPK Tubing, Fluid Delivery · General Hospital
Jul 2004 72d
EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825
K031571 · IZQ Injector, Contrast... · Radiology
Jun 2003 30d
PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400
K030854 · FCX Insufflator, Automatic... · Gastroenterology & Urology
Apr 2003 29d
PROTOCO2L INSUFFLATOR MODEL 6400
K013219 · FCX Insufflator, Automatic... · Gastroenterology & Urology
Feb 2002 146d
E-Z EM PERCUPUMP 2001 CT INJECTOR
K011160 · JAK System, X-ray,... · Radiology
May 2001 30d
PERCUPUMP II WITH EDA
K974621 · DSB Plethysmograph, Impedance · Radiology
Jan 1998 47d
PERCUPUMP II WITH EDA
K961845 · DSB Plethysmograph, Impedance · Radiology
Jan 1997 255d
HM-CAP CONTROL PANEL
K954926 · LYR Helicobacter Pylori · Microbiology
Jan 1996 96d
PERCUPUMP II
K932055 · FIH Pump, Infusion Or... · Radiology
Mar 1995 692d
E-Z-FLATE
K930581 · FCX Insufflator, Automatic... · Gastroenterology & Urology
Jul 1994 512d
E-Z-EM ENTEROCLYSIS CATHETER SET
K911349 · EZK Catheter, Retention Type · Gastroenterology & Urology
Nov 1992 600d
E-Z-FLOW ANGIOGRAPHY CATHETERS, MODIFICATION
K914984 · DQY Catheter, Percutaneous · Cardiovascular
May 1992 210d
GUIDE WIRES, MODIFICATION
K914986 · DQX Wire, Guide, Catheter · Cardiovascular
May 1992 209d
HIGH PRESSURE CONNECTING SETS, MODIFICATION
K914987 · DTL Adaptor, Stopcock,... · Cardiovascular
May 1992 209d
SONO-VU US(TM), MODIFICATION
K921738 · HIO Sampler, Amniotic Fluid... · Radiology
Apr 1992 89d
PERCUGUIDE LESION MARKING
K920816 · GDF Guide, Needle, Surgical · General & Plastic Surgery
Apr 1992 75d
ANGIOGRAPHIC FLUSH SYSTEM
K914113 · FPA Set, Administration,... · General Hospital
Jan 1992 131d
ANGIODYNAMICS ANGIOFILL FLUID MANAGEMENT SYSTEM
K914026 · FPA Set, Administration,... · General Hospital
Jan 1992 121d
SOS BLOODLESS NEEDLE
K914330 · DYB Introducer, Catheter · Cardiovascular
Dec 1991 84d
DISPOSABLE ANGIOGRAPHY NEEDLE, MODIFICATION
K914985 · DRC Trocar · Cardiovascular
Dec 1991 58d
ANGIOGRAPHIC SOFT TIP CATHETER
K914199 · DQO Catheter, Intravascular,... · Cardiovascular
Dec 1991 90d
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