Orion Life Systems, Inc.
Wheeling, IL, US
Orion Life Systems, Inc. appears in FDA device records in Wheeling, IL. FDA records list 33 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 33
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 33 510(k) clearances for Orion Life Systems, Inc. between 1990 and 1995. The busiest year on record is 1990, with 19. The most recent is 1995, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1990 | 19 |
| 1991 | 1 |
| 1993 | 2 |
| 1994 | 10 |
| 1995 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K943835 | PRE-FILLED SYRINGE W/STERILE .25% ACETC ACID | KNY | Substantially Equivalent | |
| K943836 | PRE-FILLED 10CC INFLATION SYRINGE W/STERILE WATER | JOL | Substantially Equivalent | |
| K943834 | STERILE .9% SODIUM CHLORIDE SOLUTION | JOL | Substantially Equivalent | |
| K943832 | STERILE .9% SODIUM CHLORIDE FOR IRRATION | JOL | Substantially Equivalent | |
| K943831 | PRE-FILLED 30CC INFLATION SYRINGE W/STERILE WATER | JOL | Substantially Equivalent | |
| K943830 | PRE-FILLED SYRINGE W/STERILE 0.9% SODIUM CHLORIDE SOLUTION | JOL | Substantially Equivalent | |
| K943829 | PRE-FILLED SYSRINGE W/STERILE WATER | JOL | Substantially Equivalent | |
| K943828 | STERILE WATER FOR IRRIGATION | JOL | Substantially Equivalent | |
| K943833 | STERILE WATER FOR IRRATION | JOL | Substantially Equivalent | |
| K923168 | DUAL PORT ENTERAL Y-ADAPTOR | KNT | Substantially Equivalent | |
| K923497 | FLUSHING IRRIGATION SET | KDH | Unknown | |
| K923156 | TRACHEOSTOMY CARE TRAY | JOH | Substantially Equivalent for Some Indications | |
| K923496 | URINARY CARE SUPPLIES | KNY | Unknown | |
| K904801 | ORION LIFE SYSTEMS REPLACEMENT GASTROSTOMY TUBE | KGC | Substantially Equivalent | |
| K903117 | ORION STERILE OR TOWELS | KKX | Substantially Equivalent | |
| K902813 | SHAVE PREP TRAY | Unknown | ||
| K902810 | STERILE I.V. START KIT | FPA | Unknown | |
| K902811 | ROUTINE DRESSING TRAY | MCY | Unknown | |
| K902814 | SUCTION CATHETER, STERILE | BSY | Substantially Equivalent | |
| K902828 | SUTURE REMOVAL TRAY | LRW | Unknown | |
| K902830 | PERI-BOTTLE | HED | Substantially Equivalent | |
| K901185 | FOLEY CATHETER INSERTION TRAY (10CC) | FCM | Unknown | |
| K901184 | URETHRAL CATHETER TRAY (LATEX) | FCM | Unknown | |
| K901183 | URETHRAL CATHETER TRAY (PVC) | FCM | Unknown | |
| K901181 | CATHETER CARE TRAY | FCM | Unknown | |
| K901180 | FOLEY CATHETER INSERTION TRAY (30CC) | FCM | Unknown | |
| K901182 | ENEMA BAG SET | FCE | Unknown | |
| K901179 | ENEMA BUCKET SET | FCE | Unknown | |
| K901219 | EXTERNAL LEG BAG | FAQ | Substantially Equivalent | |
| K901109 | WOUND TREATMENT KIT | FRO | Unknown | |
| K896887 | TRACHAEL SUCTION SET | BSY | Substantially Equivalent | |
| K900737 | PISTON IRRIGATION TRAY | EYN | Unknown | |
| K900736 | BULB IRRIGATION TRAY | EYN | Unknown |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KNYAccessories, Catheter, G-U
- FAQBag, Urine Collection, Leg, For External Use, Sterile
- KDHCatheter (Gastric, Colonic, Etc.), Irrigation And Aspiration
- JOLCatheter And Tip, Suction
- BSYCatheters, Suction, Tracheobronchial
- HEDDouche Apparatus, Vaginal, Therapeutic
- KKXDrape, Surgical, Antimicrobial
- FRODressing, Wound, Drug
- FCEEnema Kit
- LRWScissors, General, Surgical
- FPASet, Administration, Intravascular
- FCMTray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
- EYNTray, Irrigation, Sterile
- JOHTube Tracheostomy And Tube Cuff
- KGCTube, Gastro-Enterostomy
- KNTTubes, Gastrointestinal (And Accessories)
- MCYWound Dressing Kit
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain