MIDWEST STERILIZATION CORP.
Registration 3005012805FEI 3005012805LAREDO, TX
Owner/operator: MIDWEST STERILIZATION CORP.
- Manufacture Device in the United States for Export Only
- Manufacture Medical Device for Another Party (Contract Manufacturer)
- Sterilize Medical Device for Another Party (Contract Sterilizer)
Renewal due by December 31, 2026
Registered through 2026. Renew between October 1 and December 31, 2026, to stay registered for 2027.
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The 2026 window
- Oct 1Window opens91 days left
- Nov 3Where you stand58 days left
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- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 204
- Added, last 12 months
- 8
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 204
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| NPT | Aortic valve, prosthesis, percutaneously deliveredAortic Valve, Prosthesis, Percutaneously DeliveredAdded Jul 21, 2026 | Class 3 | — | — |
| QZI | Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible ElectroporationPercutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible ElectroporationAdded Jul 21, 2026 | Class 3 | — | — |
| NPU | Prosthesis, mitral valve, percutaneously deliveredProsthesis, Mitral Valve, Percutaneously DeliveredAdded Jul 21, 2026 | Class 3 | — | — |
| NGV | System, appendage closure, left atrialSystem, Appendage Closure, Left AtrialAdded Jul 21, 2026 | Class 3 | — | — |
| DTL | Medline stopcock and manifoldAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | Class 2 | 21 CFR 870.4290 | — |
| OFQ | Medline anesthesia kitAnesthesia Kit | Class 2 | 21 CFR 868.5120 | — |
| OEQ | Medline angiography/angioplasty kitAngiography/Angioplasty Kit | Class 2 | 21 CFR 870.1650 | — |
| CAC | PE SAHARA DRY SUC/SEAL CONT REINF LF 6Apparatus, Autotransfusion | Class 2 | 21 CFR 868.5830 | — |
| CAC | PE DRY/WET CONT REINFUSION LF 6/CSApparatus, Autotransfusion | Class 2 | 21 CFR 868.5830 | — |
| HQR | INFINITI Vision System, Accessories, and FMS PaksApparatus, Cautery, Radiofrequency, Ac-Powered | Class 2 | 21 CFR 886.4100 | — |
| OII | Medline arthrogram trayArthrogram Tray | Class 2 | 21 CFR 892.1650 | — |
| FNL | MEDLINE ASEP PLUS SURGICAL DRAPES; MEDLINE STERILE DISPOSABLE SURGICAL GOWNS/DRAPES; GORE-TEX NON-STERILE O.R. TOWELS; XBed, Ac-Powered Adjustable Hospital | Class 2 | 21 CFR 880.5100 | — |
and 192 more on your full dossier
What changed
- Jul 21, 2026Listing added: NPT — Aortic valve, prosthesis, percutaneously delivered
- Jul 21, 2026Listing added: QZI — Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
- Jul 21, 2026Listing added: NPU — Prosthesis, mitral valve, percutaneously delivered
- Jul 21, 2026Listing added: NGV — System, appendage closure, left atrial
- Jul 21, 2026Listing added: DQY — Catheter, percutaneous
- Jul 21, 2026Listing added: OBJ — Catheter, Ultrasound, Intravascular
- Jan 20, 2026Listing added: DTM — Affinity Pixie Arterial Filter with Balance Biosurface
- Apr 1, 2026Listing added: OLO — Stealth AXiS