Company ยท US
Orion Life Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1990 to 1995. Name variants (Inc, Corp, punctuation) are merged.
33510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JOL | Catheter And Tip, Suction | 8 |
| FCM | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | 5 |
| BSY | Catheters, Suction, Tracheobronchial | 2 |
| EYN | Tray, Irrigation, Sterile | 2 |
| FCE | Enema Kit | 2 |
| KNY | Accessories, Catheter, G-U | 2 |
| FAQ | Bag, Urine Collection, Leg, For External Use, Sterile | 1 |
| FPA | Set, Administration, Intravascular | 1 |
| FRO | Dressing, Wound, Drug | 1 |
| HED | Douche Apparatus, Vaginal, Therapeutic | 1 |
| JOH | Tube Tracheostomy And Tube Cuff | 1 |
| KDH | Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration | 1 |
| KGC | Tube, Gastro-Enterostomy | 1 |
| KKX | Drape, Surgical, Antimicrobial | 1 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 |
| LRW | Scissors, General, Surgical | 1 |
| MCY | Wound Dressing Kit | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 24, 1995 | K943835 | PRE-FILLED SYRINGE W/STERILE .25% ACETC ACID Orion Life Systems, Inc. | KNY |
| Nov 21, 1994 | K943836 | PRE-FILLED 10CC INFLATION SYRINGE W/STERILE WATER Orion Life Systems, Inc. | JOL |
| Nov 21, 1994 | K943834 | STERILE .9% SODIUM CHLORIDE SOLUTION Orion Life Systems, Inc. | JOL |
| Nov 21, 1994 | K943832 | STERILE .9% SODIUM CHLORIDE FOR IRRATION Orion Life Systems, Inc. | JOL |
| Nov 21, 1994 | K943831 | PRE-FILLED 30CC INFLATION SYRINGE W/STERILE WATER Orion Life Systems, Inc. | JOL |
| Nov 21, 1994 | K943830 | PRE-FILLED SYRINGE W/STERILE 0.9% SODIUM CHLORIDE SOLUTION Orion Life Systems, Inc. | JOL |
| Nov 21, 1994 | K943829 | PRE-FILLED SYSRINGE W/STERILE WATER Orion Life Systems, Inc. | JOL |
| Nov 21, 1994 | K943828 | STERILE WATER FOR IRRIGATION Orion Life Systems, Inc. | JOL |
| Nov 1, 1994 | K943833 | STERILE WATER FOR IRRATION Orion Life Systems, Inc. | JOL |
| Jun 17, 1994 | K923168 | DUAL PORT ENTERAL Y-ADAPTOR Orion Life Systems, Inc. | KNT |
| Mar 21, 1994 | K923497 | FLUSHING IRRIGATION SET Orion Life Systems, Inc. | KDH |
| Aug 18, 1993 | K923156 | TRACHEOSTOMY CARE TRAY Orion Life Systems, Inc. | JOH |
| May 27, 1993 | K923496 | URINARY CARE SUPPLIES Orion Life Systems, Inc. | KNY |
| Jan 16, 1991 | K904801 | ORION LIFE SYSTEMS REPLACEMENT GASTROSTOMY TUBE Orion Life Systems, Inc. | KGC |
| Dec 31, 1990 | K903117 | ORION STERILE OR TOWELS Orion Life Systems, Inc. | KKX |
| Nov 19, 1990 | K902813 | SHAVE PREP TRAY Orion Life Systems, Inc. | |
| Nov 13, 1990 | K902810 | STERILE I.V. START KIT Orion Life Systems, Inc. | FPA |
| Sep 25, 1990 | K902811 | ROUTINE DRESSING TRAY Orion Life Systems, Inc. | MCY |
| Aug 17, 1990 | K902814 | SUCTION CATHETER, STERILE Orion Life Systems, Inc. | BSY |
| Aug 8, 1990 | K902828 | SUTURE REMOVAL TRAY Orion Life Systems, Inc. | LRW |
| Aug 6, 1990 | K902830 | PERI-BOTTLE Orion Life Systems, Inc. | HED |
| Jul 20, 1990 | K901185 | FOLEY CATHETER INSERTION TRAY (10CC) Orion Life Systems, Inc. | FCM |
| Jul 20, 1990 | K901184 | URETHRAL CATHETER TRAY (LATEX) Orion Life Systems, Inc. | FCM |
| Jul 20, 1990 | K901183 | URETHRAL CATHETER TRAY (PVC) Orion Life Systems, Inc. | FCM |
| Jul 20, 1990 | K901181 | CATHETER CARE TRAY Orion Life Systems, Inc. | FCM |
| Jul 20, 1990 | K901180 | FOLEY CATHETER INSERTION TRAY (30CC) Orion Life Systems, Inc. | FCM |
| Jun 28, 1990 | K901182 | ENEMA BAG SET Orion Life Systems, Inc. | FCE |
| Jun 28, 1990 | K901179 | ENEMA BUCKET SET Orion Life Systems, Inc. | FCE |
| Jun 27, 1990 | K901219 | EXTERNAL LEG BAG Orion Life Systems, Inc. | FAQ |
| Jun 6, 1990 | K901109 | WOUND TREATMENT KIT Orion Life Systems, Inc. | FRO |
| Apr 23, 1990 | K896887 | TRACHAEL SUCTION SET Orion Life Systems, Inc. | BSY |
| Apr 19, 1990 | K900737 | PISTON IRRIGATION TRAY Orion Life Systems, Inc. | EYN |
| Apr 17, 1990 | K900736 | BULB IRRIGATION TRAY Orion Life Systems, Inc. | EYN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||