Company ยท US
Regulatory & Marketing Services, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1993 to 1996. Name variants (Inc, Corp, punctuation) are merged.
21510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EZL | Catheter, Retention Type, Balloon | 6 |
| FGM | Probe And Director, Gastro-Urology | 3 |
| GBX | Catheter, Irrigation | 2 |
| EZD | Catheter, Straight | 1 |
| FMI | Needle, Hypodermic, Single Lumen | 1 |
| FRG | Wrap, Sterilization | 1 |
| GZB | Stimulator, Spinal-Cord, Implanted (Pain Relief) | 1 |
| IQI | Orthosis, Limb Brace | 1 |
| JDL | Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | 1 |
| JOH | Tube Tracheostomy And Tube Cuff | 1 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | 1 |
| KNY | Accessories, Catheter, G-U | 1 |
| KOC | Accessories, Blood Circuit, Hemodialysis | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 10, 1996 | K944673 | MRI'S ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE Regulatory & Marketing Services, Inc. | EZL |
| Oct 30, 1995 | K954752 | PEDIATRIC EUROPHYLIC FOLEY CATHETER Regulatory & Marketing Services, Inc. | EZL |
| Oct 13, 1995 | K941342 | PAIN DOC Regulatory & Marketing Services, Inc. | GZB |
| Feb 16, 1995 | K941543 | DIAL MEDICAL KIT Regulatory & Marketing Services, Inc. | KOC |
| Feb 15, 1995 | K944384 | ORION'S URETHRAL CATHETERIZATION KIT WITHOUT BAG Regulatory & Marketing Services, Inc. | FGM |
| Feb 15, 1995 | K944379 | ORION'S FOLEY CATHETERIZATION KIT WITH CATHETER AND BAG Regulatory & Marketing Services, Inc. | FGM |
| Feb 15, 1995 | K944378 | ORION'S URETHRAL CATHETERIZATION KIT WITH CATHETER AND BAG Regulatory & Marketing Services, Inc. | FGM |
| Dec 27, 1994 | K945874 | EUROMEDICAL POLY TRACHEOTOMY TUBE Regulatory & Marketing Services, Inc. | JOH |
| Dec 6, 1994 | K944383 | ORION RED URETHRAL CATHETER Regulatory & Marketing Services, Inc. | EZD |
| Dec 6, 1994 | K944382 | ORION ALL SILICONE FOLEY CATHETER Regulatory & Marketing Services, Inc. | EZL |
| Dec 6, 1994 | K944377 | ORION'S URINARY DRAINAGE SET Regulatory & Marketing Services, Inc. | KNX |
| Nov 30, 1994 | K944381 | ORION ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE Regulatory & Marketing Services, Inc. | EZL |
| Nov 30, 1994 | K944380 | ORION FOLEY CATHETER Regulatory & Marketing Services, Inc. | EZL |
| Nov 30, 1994 | K944376 | ORION ALL SILICONE ELASTOMER COATED CATHETER Regulatory & Marketing Services, Inc. | EZL |
| Nov 7, 1994 | K944230 | DIAL MEDICAL SUPPLY SHARPS CONTAINER Regulatory & Marketing Services, Inc. | FMI |
| Jun 10, 1994 | K935643 | SYRIGENE ACETIC ACID PRE-FILLEDSYRINGE Regulatory & Marketing Services, Inc. | KNY |
| Jun 2, 1994 | K942274 | ORION SUCTION CATHETER KIT WITH STERILE SALINE Regulatory & Marketing Services, Inc. | GBX |
| Jun 2, 1994 | K942273 | ORION SUCTION CATHETER KIT WITH STERILE WATER Regulatory & Marketing Services, Inc. | GBX |
| May 23, 1994 | K941542 | ORION CENTRAL LINE DRESSING CHANGE TRAY Regulatory & Marketing Services, Inc. | FRG |
| Feb 18, 1994 | K935669 | SYRIGENE PRE-FILLED SYRINGE Regulatory & Marketing Services, Inc. | JDL |
| Jul 22, 1993 | K926391 | ACCUFLEX DYNAMIC ELBOW ORTHOSIS Regulatory & Marketing Services, Inc. | IQI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||