Primrose Medical, Inc. - FDA 510(k) Cleared Devices
14
Total
14
Cleared
0
Denied
FDA 510(k) Regulatory Record - Primrose Medical, Inc. Gastroenterology & Urology ✕
7 devices
Cleared
Sep 29, 1989
URETHRAL AND URETERAL BALLOON DILATATORS
Gastroenterology & Urology
325d
Cleared
Sep 29, 1989
COLONIC BALLOON DIALATORS
Gastroenterology & Urology
325d
Cleared
Sep 29, 1989
BILIARY DIALATOR
Gastroenterology & Urology
325d
Cleared
Sep 29, 1989
ACHELASIA BALLOON DIALATOR
Gastroenterology & Urology
325d
Cleared
Sep 08, 1989
ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL)
Gastroenterology & Urology
304d
Cleared
Sep 08, 1989
ESOPHAGEAL AND PYLORIC BALLOON DIALATORS
Gastroenterology & Urology
304d
Cleared
Jul 13, 1988
ENTERAL FEEDING TUBES
Gastroenterology & Urology
63d