Ballard Medical Products

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
26
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K030721QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLEMarch 31, 2003
K022398REUSABLE BRONCHIAL BIOPSY FORCEPSOctober 11, 2002
K013892LUTZ NEEDLEJuly 11, 2002
K000495BALLARD MEDICAL PRODUCTS EPIDURAL AND SPINAL NEEDLESMarch 28, 2000
K993138BALLARD MIC-KEY G LOW PROFILE GASTROSTOMY REPLACEMENT KITOctober 20, 1999
K990376BALLARD MEDICAL PRODUCTS FACILETOME BOW STRING PAPILLOTOMEMay 3, 1999
K982894MIC-KEY GLOW PROFILE GASTROSTOMY REPLACEMENT KITSeptember 11, 1998
K97463072 HOUR USE TRACH CARE WITH MICROBANMarch 11, 1998
K964369TRACH CARE SET WITH MICROBANFebruary 11, 1997
K951533EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KITJuly 5, 1995
K923487BAL CATHJuly 30, 1993
K915109RAPID ADD SITE DOUBLE LUMEN I.V.EXTENSION SETMay 8, 1992
K900273TRACH CARE MDI ADAPTERAugust 29, 1990
K895360C.P.A.P. VALVE AND C.P.P.A. KITNovember 15, 1989
K895130HEIMLICH MICRO TRACHNovember 7, 1989
K882461O2 CARENovember 28, 1988
K881790SAFETY DRAINJune 21, 1988
K873731SAFETY SHIELD KITJanuary 15, 1988
K873810SAFETY SHIELD SUCTION CATHETERDecember 11, 1987
K873732TRACH CARE START KITOctober 13, 1987