Transidyne General Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
21
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K961217BODILY FLUID DISPOSAL KITJuly 25, 1996
K955658LACERATION TRAYJanuary 25, 1996
K950773PROPHYLAXIS PACKMarch 31, 1995
K950743ORAL PROCEDURE PACKMarch 31, 1995
K950449SURGICAL BURMarch 1, 1995
K950403SURGICAL SAW BLADESFebruary 21, 1995
K924811I.V. START KITJune 17, 1993
K924243TRACHEOSTOMY CARE KITJune 16, 1993
K922339SUTURE REMOVAL KITDecember 11, 1992
K922041PRIMARY SURGICAL DRESSING TRAYNovember 6, 1992
K897133MODEL 1050 - UMBILICAL CORD BLOOD SAMPLING KITMarch 30, 1990
K8963731400 SERIES EVIDENCE COLLECTION KITFebruary 26, 1990
K8952021420 HEEL-STICK(TM) NEONATAL BLOOD SAMPLING KITSeptember 15, 1989
K8913881570 - FETAL BLOOD SAMPLING KITMarch 28, 1989
K831459FETAL BLOOD SAMPLING KIT #1560June 30, 1983
K812601SQC BUFFEROctober 2, 1981
K812552COROMETRICS MEDICAL SYST. 220 PH ANALY.September 23, 1981
K810028FETAL BLOOD SAMPLING KIT MODEL 1560January 16, 1981
K803240CORNING 760 FLUOROMETER/DENSITOMETERJanuary 9, 1981
K800271COROMETRICS MEDICAL SYSTEMS 220 PH SYS.February 26, 1980