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Primrose Medical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
14
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K884713COLONIC BALLOON DIALATORSSeptember 29, 1989
K884711URETHRAL AND URETERAL BALLOON DILATATORSSeptember 29, 1989
K884715ACHELASIA BALLOON DIALATORSeptember 29, 1989
K884714BILIARY DIALATORSeptember 29, 1989
K884709ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL)September 8, 1989
K884712ESOPHAGEAL AND PYLORIC BALLOON DIALATORSSeptember 8, 1989
K883420LANCET, BLOODAugust 26, 1988
K881976CATHETER, INTRAVASCULARAugust 4, 1988
K881977PRESSURE INFUSORJuly 29, 1988
K881975SET, INTRAVASCULARJuly 29, 1988
K881978ENTERAL FEEDING TUBESJuly 13, 1988
K873493NINJA SCALPELSeptember 24, 1987
K843071ESOPHAGEAL STETHOSCOPES W/ELEC CONDUCTORAugust 24, 1984
K843070ESOPHAGEAL STETHOSCOPESAugust 24, 1984