MEDAS, INC.
Registration 3012050423FEI 3012050423Miami, FL
Owner/operator: Medas, Inc.
- Repack or Relabel Medical Device
Renewal due by December 31, 2026
Registered through 2026. Renew between October 1 and December 31, 2026, to stay registered for 2027.
90days left in the window
The 2026 window
- Oct 1Window opens91 days left
- Nov 3Where you stand58 days left
- Dec 1Our pay-by date30 days left
- Dec 15Two weeks left16 days left
- Dec 23Holiday week8 days left
- Dec 29Two days left2 days left
- Dec 31Window closes0 days left
- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 55
- Added, last 12 months
- 4
FDA sets who pays the fee and who may qualify for a waiver; its fee page says so. The fee is paid only on FDA’s own fee site. Never through us. FDA’s fee page
The steps, in order
Pay FDA's annual feeYou
Order and pay the FY2027 establishment fee on FDA's Device Facility User Fee site. FDA emails you a PIN when you order.
FDA: registration and listing payment processWait for the payment confirmation numberYou
FDA emails a Payment Confirmation Number (PCN) once the payment processes, which FDA says typically takes several days. That is why we suggest paying by December 1.
FDA: registration and listing payment processRenew the registration in FDA's systemYou
Sign in to FDA's Unified Registration and Listing System (FURLS), complete the annual registration and apply your PIN and PCN. FDA does not count the registration as complete until both are applied.
FDA: device registration and listingReview every listingYou
In the same window, review each listing on file and report any changes, deletions and new listings. Your Listing Review Sheet puts every listing on one page.
FDA: device registration and listing
Every listed device 55
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| DTL | MEDADV SHARE MANIFOLDAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | Class 2 | 21 CFR 870.4290 | — |
| LIT | MEDADV XPANDER RX PTA PTA BALLOON CATHETERCatheter, Angioplasty, Peripheral, Transluminal | Class 2 | 21 CFR 870.1250 | K171290 |
| DXE | MEDADV ARTERIAL EMBOLECTOMY CATHETERCatheter, Embolectomy | Class 2 | 21 CFR 870.5150 | K973477 |
| MSD | MEDADV HEMODIALYSIS CATHETERCatheter, Hemodialysis, ImplantedAdded Jan 30, 2026 | Class 2 | 21 CFR 876.5540 | K241581 |
| MPB | MEDADV Hemodialysis Non Implantable CatheterCatheter, Hemodialysis, Non-Implanted | Class 2 | 21 CFR 876.5540 | K102833 |
| DQO | SPOTTER ANGIOGRAPHIC CATHETERCatheter, Intravascular, Diagnostic | Class 2 | 21 CFR 870.1200 | K090427 |
| FOZ | MEDADV Central Venous CatheterCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | Class 2 | 21 CFR 880.5200 | K070451 |
| FOZ | MEDADV CENTRAL VENOUS CATHETERCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysAdded Feb 3, 2026 | Class 2 | 21 CFR 880.5200 | K113622 |
| FOZ | Intravascular CatheterCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | Class 2 | 21 CFR 880.5200 | K142797 |
| DQY | MEDADV XPANDER PTA BALLOON DILATATION CATHETERCatheter, PercutaneousAdded Jan 23, 2026 | Class 2 | 21 CFR 870.1250 | K141354 |
| DQY | MEDADV TRACER GUIDING CATHETERCatheter, Percutaneous | Class 2 | 21 CFR 870.1250 | K180797 |
| EZL | MEDADV Retention Balloon CatheterCatheter, Retention Type, Balloon | Class 2 | 21 CFR 876.5130 | K082815 |
and 43 more on your full dossier
What changed
- Jan 30, 2026Listing added: MSD — MEDADV HEMODIALYSIS CATHETER (K241581)
- Feb 3, 2026Listing added: FOZ — MEDADV CENTRAL VENOUS CATHETER (K113622)
- Jan 23, 2026Listing added: DQY — MEDADV XPANDER PTA BALLOON DILATATION CATHETER (K141354)
- Feb 18, 2026Listing added: LOX — Catheters, Transluminal Coronary Angioplasty, Percutaneous (K211393)