Orion Life Systems, Inc. - FDA 510(k) Cleared Devices
Recent clearances: PRE-FILLED SYRINGE W/STERILE .25% ACETC ACID, STERILE WATER FOR IRRIGATION, PRE-FILLED SYSRINGE W/STERILE WATER
33
Total
16
Cleared
0
Denied
FDA 510(k) Regulatory Record - Orion Life Systems, Inc. Gastroenterology & Urology ✕
13 devices
Cleared
Jan 24, 1995
PRE-FILLED SYRINGE W/STERILE .25% ACETC ACID
Gastroenterology & Urology
172d
Cleared
Jun 17, 1994
DUAL PORT ENTERAL Y-ADAPTOR
Gastroenterology & Urology
718d
Cleared
Mar 21, 1994
FLUSHING IRRIGATION SET
Gastroenterology & Urology
614d
Cleared
May 27, 1993
URINARY CARE SUPPLIES
Gastroenterology & Urology
316d
Cleared
Jan 16, 1991
ORION LIFE SYSTEMS REPLACEMENT GASTROSTOMY TUBE
Gastroenterology & Urology
84d
Cleared
Jul 20, 1990
FOLEY CATHETER INSERTION TRAY (30CC)
Gastroenterology & Urology
129d
Cleared
Jul 20, 1990
CATHETER CARE TRAY
Gastroenterology & Urology
129d
Cleared
Jul 20, 1990
URETHRAL CATHETER TRAY (PVC)
Gastroenterology & Urology
129d
Cleared
Jul 20, 1990
URETHRAL CATHETER TRAY (LATEX)
Gastroenterology & Urology
129d
Cleared
Jul 20, 1990
FOLEY CATHETER INSERTION TRAY (10CC)
Gastroenterology & Urology
129d
Cleared
Jun 28, 1990
ENEMA BUCKET SET
Gastroenterology & Urology
107d
Cleared
Jun 28, 1990
ENEMA BAG SET
Gastroenterology & Urology
107d
Cleared
Jun 27, 1990
EXTERNAL LEG BAG
Gastroenterology & Urology
106d