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
Dec 30, 1982K823191DISPOSABLE PLASTIC STOPCOCK
Vertex Medical Corp.
DXT
Dec 30, 1982K823190BACKSTOP VALVE W/SIDE ARM
Vertex Medical Corp.
DXT
Dec 3, 1982K823356READY-BOX BODY-TEMP MEDIA WARMER MALLIN-
Forma Scientific, Inc.
DXT
Sep 28, 1982K822536MARK V
Medrad, Inc.
DXT
Jun 17, 1982K821401MALLINCKRODT DIAG. MEDIA WARMER
Forma Scientific, Inc.
DXT
Apr 29, 1980K800823QUICK FILL
Medrad, Inc.
DXT
Apr 8, 1980K800613ANGIOPLASTY INJECTOR
Medrad, Inc.
DXT
Dec 11, 1979K791793USCI PRESSURE GAUGE
C.R. Bard, Inc.
DXT
Dec 11, 1979K791782USCI BALLOON DILATATION INFLATION DEV.
C.R. Bard, Inc.
DXT
Jun 22, 1979K790835DYNAJECT
Atomic Products Corp.
DXT
Aug 17, 1978K781334DISPOSABLE SYRINGE FILL TUBE
Mallinckrodt Group, Inc.
DXT

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