Medical Device Manufacturer · US , Wheeling , IL

Orion Life Systems, Inc.

33 submissions · 16 cleared · Since 1990
33
Total
16
Cleared
0
Denied

Orion Life Systems, Inc. — FDA 510(k) Submissions

Orion Life Systems, Inc. has submitted 33 FDA 510(k) premarket notifications since 1990, of which 16 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Catheter And Tip, Suction, Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit), Catheters, Suction, Tracheobronchial, Tray, Irrigation, Sterile, Enema Kit . Use the specialty filter in the sidebar to narrow results.

33 devices
1–12 of 33
PRE-FILLED SYRINGE W/STERILE .25% ACETC ACID
K943835 · KNY Accessories, Catheter, G-u · Gastroenterology & Urology
Jan 1995 172d
STERILE WATER FOR IRRIGATION
K943828 · JOL Catheter And Tip, Suction · General Hospital
Nov 1994 108d
PRE-FILLED SYSRINGE W/STERILE WATER
K943829 · JOL Catheter And Tip, Suction · General Hospital
Nov 1994 108d
PRE-FILLED SYRINGE W/STERILE 0.9% SODIUM CHLORIDE SOLUTION
K943830 · JOL Catheter And Tip, Suction · General Hospital
Nov 1994 108d
PRE-FILLED 30CC INFLATION SYRINGE W/STERILE WATER
K943831 · JOL Catheter And Tip, Suction · General Hospital
Nov 1994 108d
STERILE .9% SODIUM CHLORIDE FOR IRRATION
K943832 · JOL Catheter And Tip, Suction · General Hospital
Nov 1994 108d
STERILE .9% SODIUM CHLORIDE SOLUTION
K943834 · JOL Catheter And Tip, Suction · General Hospital
Nov 1994 108d
PRE-FILLED 10CC INFLATION SYRINGE W/STERILE WATER
K943836 · JOL Catheter And Tip, Suction · General Hospital
Nov 1994 108d
STERILE WATER FOR IRRATION
K943833 · JOL Catheter And Tip, Suction · General Hospital
Nov 1994 88d
DUAL PORT ENTERAL Y-ADAPTOR
K923168 · KNT Tubes, Gastrointestinal... · Gastroenterology & Urology
Jun 1994 718d
FLUSHING IRRIGATION SET
K923497 · KDH Catheter (gastric,... · Gastroenterology & Urology
Mar 1994 614d
TRACHEOSTOMY CARE TRAY
K923156 · JOH Tube Tracheostomy And... · Anesthesiology
Aug 1993 415d
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