Excelsior Medical Corp

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
9
Inspections
8
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1989-2016Class IIExcelsior Disposable Syringe Heparin Lock Flush, USP syringe (5 mL Fill in 10 mL syringe). For flusApril 28, 2016
Z-2070-2014Class IIExcelsior Medical Sterile Triple Lead Tubing Set and Sterile Heavy Duty Triple Lead Tubing Set. To June 5, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K130975SWABCAP AND SWABFLUSHDecember 24, 2013
K101270SWABFLSUH (3ML, 5ML, 10ML) MODEL 10331, 10351, 10311February 10, 2011
K083508SWABCAPApril 28, 2009
K082837STERILE FIELD SALINE PRE-FILLED SYRINGE(S)December 18, 2008
K061497SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/MLFebruary 23, 2007
K053120STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGESDecember 9, 2005
K023740SYREX PRE-FILLED SYRINGEMay 13, 2003
K962938EXCELSIOR DISPOSABLE SYRINGE W/NORMAL SALINE (.9% SODIUM CHLORIDE)October 25, 1996
K942349MICROBORE EXTENSION SETFebruary 8, 1995