Gish Biomedical, Inc. - FDA 510(k) Cleared Devices
Recent clearances: MEDOS HILITE INFANT OXYGENATOR, MODEL 1000, 800 LT, MEDOS HILITE PEDIATRIC OXYGENATOR, MODELS 2800, 2400 LT, MEDOS HILITE INFANT RESERVOIR, MODEL MVC 0730
75
Total
75
Cleared
0
Denied
FDA 510(k) Regulatory Record - Gish Biomedical, Inc. Cardiovascular ✕
61 devices
Cleared
Sep 18, 2009
MEDOS HILITE INFANT OXYGENATOR, MODEL 1000, 800 LT
Cardiovascular
210d
Cleared
Sep 18, 2009
MEDOS HILITE PEDIATRIC OXYGENATOR, MODELS 2800, 2400 LT
Cardiovascular
210d
Cleared
Aug 04, 2009
MEDOS HILITE INFANT RESERVOIR, MODEL MVC 0730
Cardiovascular
112d
Cleared
Jul 30, 2009
MEDOS HILITE RESERVOIR, MODEL: 4030
Cardiovascular
280d
Cleared
May 15, 2009
MEDOS HILITE OXYGENATOR, MODEL 7000 & 7000 LT
Cardiovascular
267d
Cleared
Feb 04, 2009
GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH HA COATING
Cardiovascular
211d
Cleared
Feb 04, 2009
GISH SVR SOFT VENOUS RESERVOIRS WITH HA COATING
Cardiovascular
196d
Cleared
Feb 02, 2009
VISION HOLLOW FIBER OXYGENATOR WITH HA COATING
Cardiovascular
327d
Cleared
Jan 26, 2009
GISH VISION BLOOD CARDIOPLEGIA WITH HA COATING
Cardiovascular
210d
Cleared
Jan 23, 2009
GISH TUBING AND CONNECTORS WITH HA COATING
Cardiovascular
205d
Cleared
Jan 15, 2009
GISH ARTERIAL FILTER WITH HA COATING
Cardiovascular
276d
Cleared
Aug 12, 2005
GISH ATR2900 AND CAP35 SERIES RESERVOIRS WITH GBS COATING
Cardiovascular
57d
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