Concord/Portex

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
23
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K923559STERI-CATH MDIOctober 25, 1993
K930218SUBCUTANEOUS TUNNELING NEEDLE AND HANDLESJuly 27, 1993
K924541EPIDURAL MINIPACKJuly 9, 1993
K930286DRI-VENDT/PROVENT/ACCUVENT ARTERIAL BLOOD GAS KITSJune 22, 1993
K923127NEEDLE-PRO CARTRIDGEApril 29, 1993
K923910HEAT MOISTURE CONDENSERJanuary 26, 1993
K922749LOW PROFILE TRACHEOSTOMY TUBESeptember 2, 1992
K922445VACU-PROAugust 12, 1992
K915452ANESTHESIA BREATHING CIRCUITFebruary 14, 1992
K911809NEW-VENTAugust 26, 1991
K912124TRACHEOSTOMY TUBE AND CUFFAugust 16, 1991
K912043ACCU-VENT(TM) WITH NEEDLE-PRO(TM)July 5, 1991
K911638SYRINGE TIP CAPJune 21, 1991
K911037SAFETY NEEDLE SHEATH, MODIFICATIONMay 3, 1991
K905011ORAL PHARYNGEAL CLEANSING DEVICEJanuary 31, 1991
K904198SAFETY NEEDLE SHEATHDecember 19, 1990
K903730D.I.C. TRACHEOSTOMY TUBES & LARYNGECTOMY TUBESSeptember 25, 1990
K902687STERI-CATH-DLAugust 29, 1990
K902116MODIFIED ENDOBRONCHIAL TUBEAugust 3, 1990
K902383STERI-CATH(TM)July 12, 1990