Ackrad Laboratories

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
42
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K021272SIB CATHETER, MODEL 61-7005May 21, 2002
K020954H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE TRAY & MULTIPURPOSE PRApril 24, 2002
K020951H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007April 16, 2002
K970492INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETERApril 9, 1997
K961752H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607)August 8, 1996
K940176ACKRAD IUI SET FOR INTRAUTERINE INSEMINATIONApril 23, 1996
K952542ACKRAD ESOPHAGEAL BALLOON CATHETER SETApril 23, 1996
K953034H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607)August 29, 1995
K915813ACKRAD ERCP CONTRAST DELIVERY SETMarch 11, 1992
K904499NICOS (NON-INVASIVE CARDIAC OUTPUT SYSTEM)July 1, 1991
K911780INFANT NASAL CANNULAE ASSEMBLY, MODIFIEDJune 24, 1991
K901574ACKRAD MPR DRAINAGE CATHETER SETJune 29, 1990
K895031MODIFIED INFANT NASAL CANNULAE ASSEMBLYOctober 30, 1989
K881680ACKRAD H/S PROCEDURE TRAYJuly 15, 1988
K880161ACKRAD PEDIATRIC C.P.A.P. SYSTEMMarch 4, 1988
K874293ACKRAD V/CUG VOIDING CYSTOURETHROGRAPHY SETDecember 29, 1987
K874312ACKRAD RETROGRADE URETHROGRAPHY SETDecember 29, 1987
K872277TRAKEFIT TRACHEOSTOMY TUBE HOLDERJuly 21, 1987
K864818ACKRAD TDI SETApril 9, 1987
K871069MODIFIED HYSTEROSALPINGOGRAPY SETApril 6, 1987