FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

62 results for "E-Z-Em, Inc."
1–24 of 62
Search insights Median review: 86d Cleared: 100% Top manufacturer: E-Z-Em, Inc. Lead specialty: Cardiovascular
Cleared Jun 13, 2007
MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIES
K071378 · JAK
E-Z-Em, Inc.
Radiology · 27d
Cleared Apr 13, 2007
EMPOWERMR INJECTOR SYSTEM, MODEL 9730
K062449 · IZQ
E-Z-Em, Inc.
Cardiovascular · 234d
Cleared Nov 02, 2006
EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900
K063029 · JAK
E-Z-Em, Inc.
Radiology · 31d
Cleared Dec 27, 2005
E-Z-EM ENDOSCOPIC CO2 REGULATOR
K053008 · FCX
E-Z-Em, Inc.
Gastroenterology & Urology · 62d
Cleared Jul 16, 2004
EMPOWER TRANSFER SET, (CAT. NO. 7725)
K041178 · FPK
E-Z-Em, Inc.
General Hospital · 72d
Cleared Jun 19, 2003
EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825
K031571 · IZQ
E-Z-Em, Inc.
Radiology · 30d
Cleared Apr 16, 2003
PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400
K030854 · FCX
E-Z-Em, Inc.
Gastroenterology & Urology · 29d
Cleared Feb 19, 2002
PROTOCO2L INSUFFLATOR MODEL 6400
K013219 · FCX
E-Z-Em, Inc.
Gastroenterology & Urology · 146d
Cleared May 16, 2001
E-Z EM PERCUPUMP 2001 CT INJECTOR
K011160 · JAK
E-Z-Em, Inc.
Radiology · 30d
Cleared Jan 27, 1998
PERCUPUMP II WITH EDA
K974621 · DSB
E-Z-Em, Inc.
Radiology · 47d
Cleared Jan 23, 1997
PERCUPUMP II WITH EDA
K961845 · DSB
E-Z-Em, Inc.
Radiology · 255d
Cleared Jul 17, 1996
PULSE*SPRAY INFUSION SYSTEM
K961763 · QEY
Angiodynamics, Div. E-Z-Em, Inc.
Cardiovascular · 71d
Cleared Jan 30, 1996
HM-CAP CONTROL PANEL
K954926 · LYR
E-Z-Em, Inc.
Microbiology · 96d
Cleared Jun 16, 1995
PULSE*SPRAY INFUSION SYSTEM
K951509 · QEY
Angiodynamics, Div. E-Z-Em, Inc.
Cardiovascular · 74d
Cleared Jun 14, 1995
PULSE*SPRAY INFUSION SYSTEM
K951602 · KRA
Angiodynamics, Div. E-Z-Em, Inc.
Cardiovascular · 92d
Cleared May 17, 1995
PULSE*SPRAY INFUSION SYSTEM
K950907 · QEY
Angiodynamics, Div. E-Z-Em, Inc.
Cardiovascular · 93d
Cleared Mar 21, 1995
PERCUPUMP II
K932055 · FIH
E-Z-Em, Inc.
Radiology · 692d
Cleared Dec 13, 1994
ANGIOGRAPHY SYRINGE KITS
K933846 · DXT
Angiodynamics, Div. E-Z-Em, Inc.
Cardiovascular · 494d
Cleared Jul 01, 1994
E-Z-FLATE
K930581 · FCX
E-Z-Em, Inc.
Gastroenterology & Urology · 512d
Cleared Nov 16, 1992
E-Z-EM ENTEROCLYSIS CATHETER SET
K911349 · EZK
E-Z-Em, Inc.
Gastroenterology & Urology · 600d
Cleared Sep 01, 1992
MICROGUIDE LESION MARKING SYSTEM
K923120 · GDF
Angiodynamics, Div. E-Z-Em, Inc.
General & Plastic Surgery · 67d
Cleared May 20, 1992
HIGH PRESSURE CONNECTING SETS, MODIFICATION
K914987 · DTL
E-Z-Em, Inc.
Cardiovascular · 209d
Cleared May 20, 1992
GUIDE WIRES, MODIFICATION
K914986 · DQX
E-Z-Em, Inc.
Cardiovascular · 209d
Cleared May 20, 1992
E-Z-FLOW ANGIOGRAPHY CATHETERS, MODIFICATION
K914984 · DQY
E-Z-Em, Inc.
Cardiovascular · 210d