ClearanceBrief
Panels › Cardiovascular › Product code DXT · Class 2

Injector And Syringe, Angiographic

Regulation 870.1650

7510(k)s in 12 months (211 all time)
8recalls in 12 months (70 all time)
58recalls that name a 510(k)
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Top companies in DXT

Company510(k)sRecalls
Medrad, Inc.3211
Merit Medical Systems, Inc.718
Acist Medical Systems128
Osprey Medical150
Bayer Medical Care, Inc.85
Coeur, Inc.100
Mallinckrodt Inc010
Mallinckrodt Inc., Liebel-Flarsheim Business70
Medline Industries, Inc.16
Nemoto Kyorindo Co., Ltd.70
Decided510(k)Device and applicantCode
May 22, 1990K900034ANGIO-MAX
Accumed Systems, Inc.
DXT
Jan 19, 1990K896415USCI PRESTO DISPOSABLE INFLATION DEVICE
C.R. Bard, Inc.
DXT
Jan 19, 1990K895318B-D ANGIOGRAPHIC CONTROL SYRINGE
Bd Becton Dickinson Vacutainer Systems Preanalytic
DXT
Jun 22, 1989K890292PCA-10, 10CC DISP. ANGIOGRAPHY CONTROL SYRINGE
Coeur Laboratories, Inc.
DXT
May 19, 1989K890208HIGH PRESSURE CONNECTING SETS
E-Z-Em, Inc.
DXT
Apr 18, 1989K884913MERIT INTELLIFLATOR(TM) & MERIT MONITOR(TM)
Merit Medical Systems, Inc.
DXT
Apr 12, 1989K890898MODEL 611101 CONTRAST INJECTION DEVICE
Medtronic Versaflex, Inc.
DXT
Dec 1, 1988K883769EXCEL INFLATE-AID
Medical Profiles, Inc.
DXT
Oct 14, 1988K883452ACS INDEFLATOR P/T 20
Advanced Cardiovascular Systems, Inc.
DXT
Sep 2, 1988K882329L-F COILED EXTENSION TUBING
Mallinckrodt Group, Inc.
DXT
May 31, 1988K881521MODIFIED SERVO SYRINGE
Engineering, Inc.
DXT
May 31, 1988K880877CONTRAST INJECTION DEVICE
Med-West, Inc.
DXT
May 13, 1988K880987INJECTOR HANDLE WITH SYRINGE
Applied Vascular Devices, Inc.
DXT
Apr 28, 1988K880493MEDRAD MICROPROCESSOR CT INJECTION SYSTEM
Medrad, Inc.
DXT
Apr 22, 1988K880310ANGIO DRAPE PACK ACP-010FM
Arrow Intl., Inc.
DXT
Mar 25, 1988K875324MODIFIED SCHNEIDER SHILEY INFLATION SYRINGES
Schneider-Shilley (Usa)
DXT
Mar 25, 1988K873410DISPOSABLE ANGIOGRAPHIC, CONTROL SYRINGE
Blood Gas Supply Co.
DXT
Feb 11, 1988K875196DISPOSABLE CORONARY CONTROL SYRINGE 12CC
Merit Medical Systems, Inc.
DXT
Feb 5, 1988K873955NAMIC ANGIOGRAPHIC SYRINGE
North American Instrument Corp.
DXT
Feb 5, 1988K873173MEDRAD MRI INJECTION SYSTEM
Medrad, Inc.
DXT
Nov 12, 1987K873597TUBING, POLYETHYLENE
Coeur Laboratories, Inc.
DXT
Oct 20, 1987K872981ACS INDEFLATOR PLUS (MODIFICATION #2)
Advanced Cardiovascular Systems, Inc.
DXT
Oct 9, 1987K873687ANGIOMAT CT INJECTOR
Mallinckrodt Group, Inc.
DXT
Sep 14, 1987K872472SCHNEIDER-SHILEY BIFLATOR BALLOON INFLATION DEVICE
Angiomedics, Inc.
DXT
Aug 28, 1987K871129CAVROPUMP
Life-Tech Intl., Inc.
DXT
Nov 20, 1986K863596CHIN-FOGARTY INFLATION DEVICE
American Edwards Laboratories
DXT
Oct 31, 1986K863537CORDIS REUSABLE INFLATION DEVICE FOR ANGIOPLASTY
Cordis Corp.
DXT
Sep 23, 1986K863037USCI (R) DISPOSABLE INFLATION DEVICE
C.R. Bard, Inc.
DXT
Sep 3, 1986K862547MECHANICAL INFLATION DEVICE
American Edwards Laboratories
DXT
May 2, 1986K860204ANGIOMAT 6000
Mallinckrodt Group, Inc.
DXT
Apr 23, 1986K860842ANGIOJECT
Target Therapeutics
DXT
Feb 18, 1986K850861ROENTGENOGRAPHY SET & PRESSURE MONITORING LINE
Medical Components, Inc.
DXT
Dec 4, 1985K854310ACS INDEFLATOR (MODIFICATION)
Advanced Cardiovascular Systems, Inc.
DXT
Jul 24, 1985K841092HIGH PRESSURE FLEX. CONNECTING TUBING
Tronomed, Inc.
DXT
Jun 10, 1985K851402LEVEEN INFLATOR DISPOSABLE INFLATION SYRINGE
Medi-Tech, Inc.
DXT
Nov 13, 1984K844045ADVANCED CARDIOVASCULAR SYSTEMS ANGIOJECT
Advanced Cardiovascular Systems, Inc.
DXT
Jun 11, 1984K841493MODEL 1000 APC-ANGIOPLASTY PRESSURE
E.A. Fischione Instrument Mfg.
DXT
Apr 17, 1984K840281ANGIOGRAPHIC DRAPE PACKS
Medrad, Inc.
DXT
Apr 17, 1984K833645CONTRAST MEDIA INJECT. SET CMS
Gish Biomedical, Inc.
DXT
Jan 13, 1984K834107ANGIOPLASTY INFLATION DEVICE & CARTR
Cordis Corp.
DXT
Nov 14, 1983K833138DIGITAL INJECTOR SYS
Sybron Corp.
DXT
Aug 12, 1983K830754BLOOD PRESSURE MONITORING KITS,WALRUS
Medical Parameters, Inc.
DXT
Mar 24, 1983K830609INFLATION DEVICE
Interventional Medical, Inc.
DXT
Feb 18, 1983K823920COEURLOCK STERILE DISPOS. ANGIOGRAPHIC
Coeur Laboratories, Inc.
DXT
Dec 30, 1982K823340CLEAR VINYL MONITORING CONNECTOR
Vertex Medical Corp.
DXT
Dec 30, 1982K823256ULTRA-ASEPT ANGIOGRAPHIC SYRINGE/SPARE
Vertex Medical Corp.
DXT
Dec 30, 1982K823254REUSABLE METAL STOPCOCK
Vertex Medical Corp.
DXT
Dec 30, 1982K823253VERTEX MONITORING CATHETER
Vertex Medical Corp.
DXT
Dec 30, 1982K823238INJECTION FILL TUBE
Vetrex Medical Corp.
DXT
Dec 30, 1982K823192TUOHY-BORST ADAPTER W/SIDE ARM
Vertex Medical Corp.
DXT

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