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Kendall

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
20
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K092797ACUTE AND CHRONIC CATHETER REPAIR KITNovember 19, 2009
K06267114.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING AND SILVER IMPREGNATED SLEEVE (PALINDROMENovember 3, 2006
K061936KENDALL ARGYLE NEONATAL/PEDIATRIC PICC, MODEL 43311August 9, 2006
K060972KEDALL 14.5 FR CHRONIC HEMODIALYSIS CATHETER W/SILVER IMPREGNATED SLEEVE (PALINDROME RUBY)August 4, 2006
K053410GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTORJanuary 6, 2006
K05158414.5 FR CHRONIC HEMODIALYSIS CATHETER WITH INSERTION STYLETS ACCESSORYOctober 6, 2005
K043272PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER WITH SLOTTED SYMMETRICAL TIPDecember 22, 2004
K042461KENDALL ARGYLE 2 FR DOUBLE LUMEN NEONATAL/PEDIATRIC PICC, MODEL 43304December 10, 2004
K042572KENDALL CO2NFIRM NOW CO2 DETECTORNovember 5, 2004
K041914PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETERSeptember 27, 2004
K041006TANDEM-CATH HEMODIALYSIS CATHETER, MODEL 10 FRMay 19, 2004
K040388NEXT GENERATION SALEM SUMPMay 17, 2004
K033676PALINDROME 14.5 FR CHRONIC HEMODIALYSIS CATHETERFebruary 20, 2004
K030209MAHURKAR OPLUS CATHETER, MODEL 13.5 FRMay 13, 2003
K020089MAHURKAR TRIPLE LUMEN CATHETER, 12 FRApril 10, 2002
K011283MONOJECT PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGEOctober 15, 2001
K011941EXCILON AMD ANTIMICROBIAL SPONGE MODEL #7088August 22, 2001
K002902TANDEM-CATH 10 FR. CATHETER SYSTEM, MODEL MULTIPLE CODE NUMBERSApril 9, 2001
K002901KENDALL 14.5 FR MAXID CUFFED DUAL LUMEN CATHETERMarch 28, 2001
K003313FILAC FAS TEMP ELECTRONIC THERMOMETERJanuary 11, 2001