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."
25–48 of 62
Search insights Median review: 86d Cleared: 100% Top manufacturer: E-Z-Em, Inc. Lead specialty: Cardiovascular
Cleared Apr 27, 1992
SONO-VU US(TM), MODIFICATION
K921738 · HIO
E-Z-Em, Inc.
Radiology · 89d
Cleared Apr 21, 1992
PERCUGUIDE LESION MARKING
K920816 · GDF
E-Z-Em, Inc.
General & Plastic Surgery · 75d
Cleared Jan 22, 1992
ANGIOGRAPHIC FLUSH SYSTEM
K914113 · FPA
E-Z-Em, Inc.
General Hospital · 131d
Cleared Jan 09, 1992
ANGIODYNAMICS ANGIOFILL FLUID MANAGEMENT SYSTEM
K914026 · FPA
E-Z-Em, Inc.
General Hospital · 121d
Cleared Dec 20, 1991
DISPOSABLE ANGIOGRAPHY NEEDLE, MODIFICATION
K914985 · DRC
E-Z-Em, Inc.
Cardiovascular · 58d
Cleared Dec 20, 1991
SOS BLOODLESS NEEDLE
K914330 · DYB
E-Z-Em, Inc.
Cardiovascular · 84d
Cleared Dec 18, 1991
ANGIOGRAPHIC SOFT TIP CATHETER
K914199 · DQO
E-Z-Em, Inc.
Cardiovascular · 90d
Cleared Jul 24, 1991
GASPARAITIS ESOPHAGRAM CATHETER SET
K911897 · KNT
E-Z-Em, Inc.
Gastroenterology & Urology · 86d
Cleared Jun 24, 1991
SONO-VU US(TM)
K904583 · HIO
E-Z-Em, Inc.
Radiology · 258d
Cleared Jun 10, 1991
EIA FOR DETECTION OF ANTIBODIES H. PYLORI
K905409 · LYR
E-Z-Em, Inc.
Microbiology · 189d
Cleared Apr 01, 1991
E-Z-EM PULSED INFUSION SYSTEM
K905447 · KRA
E-Z-Em, Inc.
Cardiovascular · 117d
Cleared Jan 24, 1991
SLIM LINE RETENTION TIP W/ SILICONE RUBBER CUFF
K905574 · FGD
E-Z-Em, Inc.
Gastroenterology & Urology · 43d
Cleared Nov 27, 1990
SLIM LINE RETENT TIP W/SILICONE INFLATION CUFF
K904299 · FGD
E-Z-Em, Inc.
Gastroenterology & Urology · 69d
Cleared Mar 29, 1990
PERCU-SET(TM)
K900021 · HIO
E-Z-Em, Inc.
Obstetrics & Gynecology · 86d
Cleared Dec 27, 1989
E-Z-EM VACUUM ASPIRATION SYRINGE
K895012 · GAA
E-Z-Em, Inc.
General & Plastic Surgery · 141d
Cleared May 31, 1989
INTERVENTIONAL PRODUCTS - GUIDE WIRES
K890207 · DQX
E-Z-Em, Inc.
Cardiovascular · 134d
Cleared May 19, 1989
DISPOSABLE ANGIOGRAPHY NEEDLES
K890209 · DRC
E-Z-Em, Inc.
Cardiovascular · 122d
Cleared May 19, 1989
HIGH PRESSURE CONNECTING SETS
K890208 · DXT
E-Z-Em, Inc.
Cardiovascular · 122d
Cleared May 19, 1989
E-Z-FLOW ANGIOGRAPHY CATHETERS
K890206 · DQO
E-Z-Em, Inc.
Cardiovascular · 122d
Cleared Jan 31, 1989
WINGED INFUSION SET
K885264 · FPA
E-Z-Em, Inc.
General Hospital · 40d
Cleared Jul 25, 1988
E-Z-EM(R) LUFKIN BIOPSY NEEDLES
K882601 · GDM
E-Z-Em, Inc.
General & Plastic Surgery · 31d
Cleared Jan 16, 1987
PERCUPUMP (TM)
K864227 · FRN
E-Z-Em, Inc.
Radiology · 80d
Cleared Aug 29, 1986
PERCU GUIDE I (LOOP TYPE)
K863090 · GDF
E-Z-Em, Inc.
General & Plastic Surgery · 16d
Cleared Dec 18, 1985
BRONCHIAL CYTOLOGY BRUSH
K853667
E-Z-Em, Inc.
Cardiovascular · 106d