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Gish Biomedical, Inc.

FDA 510(k) & PMA Approved Devices — 75 products

Total Devices75
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K090450 MEDOS HILITE PEDIATRIC OXYGENATOR, MODELS 2800, 2400 LTDTZ2009-09-18 View
510(k) K090449 MEDOS HILITE INFANT OXYGENATOR, MODEL 1000, 800 LTDTZ2009-09-18 View
510(k) K091062 MEDOS HILITE INFANT RESERVOIR, MODEL MVC 0730DTN2009-08-04 View
510(k) K083131 MEDOS HILITE RESERVOIR, MODEL: 4030DTN2009-07-30 View
510(k) K082403 MEDOS HILITE OXYGENATOR, MODEL 7000 & 7000 LTDTZ2009-05-15 View
510(k) K082082 GISH SVR SOFT VENOUS RESERVOIRS WITH HA COATINGDTN2009-02-04 View
510(k) K081947 GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH HA COATINGDTN2009-02-04 View
510(k) K080708 VISION HOLLOW FIBER OXYGENATOR WITH HA COATINGDTZ2009-02-02 View
510(k) K081838 GISH VISION BLOOD CARDIOPLEGIA WITH HA COATINGDTR2009-01-26 View
510(k) K081881 GISH TUBING AND CONNECTORS WITH HA COATINGDWF2009-01-23 View
510(k) K081054 GISH ARTERIAL FILTER WITH HA COATINGDTM2009-01-15 View
510(k) K051606 GISH ATR2900 AND CAP35 SERIES RESERVOIRS WITH GBS COATINGDTN2005-08-12 View
510(k) K050195 V-BAG WITH GBS COATINGDTN2005-03-17 View
510(k) K040355 VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPORAL HEAT EXCHANGER WITH GBS COATINGDTR2004-03-15 View
510(k) K030726 GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH GBS COATINGDTN2003-05-30 View
510(k) K031300 IBC FLOPUMP WITH GBS COATINGKFM2003-05-14 View
510(k) K023381 VISION HOLLOW FIBER OXYGENATOR WITH GUARDIAN COATINGDTZ2003-03-31 View
510(k) K023833 GISH ARTERIAL FILTER WITH GBS COATINGDTM2003-03-31 View
510(k) K030077 GISH TUBING AND CONNECTORS WITH GBS COATINGDTL2003-03-14 View
510(k) K024065 SOFT VENOUS RESERVOIR (SVRXX) WITH GBS COATINGDTN2003-03-05 View
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