Regulatory & Marketing Services, Inc.
Appollo Beach, FL, US
Regulatory & Marketing Services, Inc. appears in FDA device records in Appollo Beach, FL. FDA records list 22 510(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
- 22
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 22 510(k) clearances for Regulatory & Marketing Services, Inc. between 1993 and 2011. The busiest year on record is 1994, with 13. The most recent is 2011, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1993 | 1 |
| 1994 | 13 |
| 1995 | 6 |
| 1996 | 1 |
| 2011 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K101721 | WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA | BTO | Substantially Equivalent | |
| K944673 | MRI'S ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE | EZL | Substantially Equivalent | |
| K954752 | PEDIATRIC EUROPHYLIC FOLEY CATHETER | EZL | Substantially Equivalent | |
| K941342 | PAIN DOC | GZB | Substantially Equivalent | |
| K941543 | DIAL MEDICAL KIT | KOC | Unknown | |
| K944384 | ORION'S URETHRAL CATHETERIZATION KIT WITHOUT BAG | FGM | Substantially Equivalent | |
| K944379 | ORION'S FOLEY CATHETERIZATION KIT WITH CATHETER AND BAG | FGM | Substantially Equivalent | |
| K944378 | ORION'S URETHRAL CATHETERIZATION KIT WITH CATHETER AND BAG | FGM | Substantially Equivalent | |
| K945874 | EUROMEDICAL POLY TRACHEOTOMY TUBE | JOH | Substantially Equivalent | |
| K944383 | ORION RED URETHRAL CATHETER | EZD | Substantially Equivalent | |
| K944382 | ORION ALL SILICONE FOLEY CATHETER | EZL | Substantially Equivalent | |
| K944377 | ORION'S URINARY DRAINAGE SET | KNX | Substantially Equivalent | |
| K944381 | ORION ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE | EZL | Substantially Equivalent | |
| K944380 | ORION FOLEY CATHETER | EZL | Substantially Equivalent | |
| K944376 | ORION ALL SILICONE ELASTOMER COATED CATHETER | EZL | Substantially Equivalent | |
| K944230 | DIAL MEDICAL SUPPLY SHARPS CONTAINER | FMI | Substantially Equivalent | |
| K935643 | SYRIGENE ACETIC ACID PRE-FILLEDSYRINGE | KNY | Substantially Equivalent | |
| K942274 | ORION SUCTION CATHETER KIT WITH STERILE SALINE | GBX | Unknown | |
| K942273 | ORION SUCTION CATHETER KIT WITH STERILE WATER | GBX | Unknown | |
| K941542 | ORION CENTRAL LINE DRESSING CHANGE TRAY | FRG | Unknown | |
| K935669 | SYRIGENE PRE-FILLED SYRINGE | JDL | Substantially Equivalent | |
| K926391 | ACCUFLEX DYNAMIC ELBOW ORTHOSIS | IQI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KOCAccessories, Blood Circuit, Hemodialysis
- KNYAccessories, Catheter, G-U
- GBXCatheter, Irrigation
- EZLCatheter, Retention Type, Balloon
- EZDCatheter, Straight
- KNXCollector, Urine, (And Accessories) For Indwelling Catheter
- FMINeedle, Hypodermic, Single Lumen
- IQIOrthosis, Limb Brace
- FGMProbe And Director, Gastro-Urology
- JDLProsthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
- GZBStimulator, Spinal-Cord, Implanted (Pain Relief)
- JOHTube Tracheostomy And Tube Cuff
- BTOTube, Tracheostomy (W/Wo Connector)
- FRGWrap, Sterilization
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Regulatory & Marketing Services, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Regulatory & Marketing Services, Inc.. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.
Data as of , FDA export datePage updated Source: openFDA, public domain