Medical Device Manufacturer · US , Mchenry , IL

E-Z-Em, Inc. - FDA 510(k) Cleared Devices

56 submissions · 56 cleared · Since 1977
56
Total
56
Cleared
0
Denied
FDA 510(k) Regulatory Record - E-Z-Em, Inc. Gastroenterology & Urology
16 devices
1-16 of 16
Cleared Dec 27, 2005
E-Z-EM ENDOSCOPIC CO2 REGULATOR
K053008 · FCX
Gastroenterology & Urology · 62d
Cleared Apr 16, 2003
PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400
K030854 · FCX
Gastroenterology & Urology · 29d
Cleared Feb 19, 2002
PROTOCO2L INSUFFLATOR MODEL 6400
K013219 · FCX
Gastroenterology & Urology · 146d
Cleared Jul 01, 1994
E-Z-FLATE
K930581 · FCX
Gastroenterology & Urology · 512d
Cleared Nov 16, 1992
E-Z-EM ENTEROCLYSIS CATHETER SET
K911349 · EZK
Gastroenterology & Urology · 600d
Cleared Jul 24, 1991
GASPARAITIS ESOPHAGRAM CATHETER SET
K911897 · KNT
Gastroenterology & Urology · 86d
Cleared Jan 24, 1991
SLIM LINE RETENTION TIP W/ SILICONE RUBBER CUFF
K905574 · FGD
Gastroenterology & Urology · 43d
Cleared Nov 27, 1990
SLIM LINE RETENT TIP W/SILICONE INFLATION CUFF
K904299 · FGD
Gastroenterology & Urology · 69d
Cleared Nov 05, 1985
E-Z-EM GASTRIC LAVAGE CATHETER
K853384 · KNT
Gastroenterology & Urology · 85d
Cleared Nov 05, 1985
ENDODYNAMICS SIEGEL THERAPUTIC STENT
K853666 · FGE
Gastroenterology & Urology · 63d
Cleared Nov 04, 1985
ENDODYNAMIC SIEGEL SPHINCTEROTOME
K853680 · KNS
Gastroenterology & Urology · 61d
Cleared Oct 04, 1985
ENDO DYNAMICS GASTROINTESTINAL CYTOLOGY BRUSH
K853530 · FDX
Gastroenterology & Urology · 42d
Cleared Oct 01, 1984
E-Z-EM SINGLE STICK PUNCTURE/DRAINAGE
K842121 · LJE
Gastroenterology & Urology · 125d
Cleared Jul 26, 1984
E-Z-EM PERCUTANEOUS NEPHROSTOMY SETS
K841720 · LJE
Gastroenterology & Urology · 92d
Cleared Jul 09, 1984
CYSTO-AID
K841197 · KNX
Gastroenterology & Urology · 110d
Cleared May 02, 1984
ENTEROCYSIS TUBE W/GUIDE WIRE & CONNECT
K840752 · KNT
Gastroenterology & Urology · 69d
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