Minnesota FDA 510(k) clearances, last 90 days
US companies with an FDA 510(k) clearance and a Minnesota address from Aug 2, 2026 to Oct 30, 2026. FDA data through October 30, 2026.
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Last 90 days
22 clearances in the last 90 days. The same 90 days a year earlier: 17.
For contract manufacturers and test labs
Minnesota had 22 US 510(k) clearances in the last 90 days and 84 in the last 12 months. The product code with the most clearances in this window is DQK (Computer, Diagnostic, Programmable). Contract manufacturers and test labs that sell to device companies in Minnesota can read the company, the device and the date below, then open the FDA record. Contacts for these companies come with a free month.
Top product codes
| Product code | Device type | Clearances |
|---|---|---|
DQK | Computer, Diagnostic, Programmable | 3 |
NBC | Test, Natriuretic Peptide | 2 |
DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 1 |
EZD | Catheter, Straight | 1 |
EZL | Catheter, Retention Type, Balloon | 1 |
| Decision date | Company | Device | FDA record |
|---|---|---|---|
| Oct 29, 2026 | Canon Medical Informatics, Inc. | Vitrea Advanced Visualization, Version 7.16 | K263648 |
| Oct 29, 2026 | Medtronic, Inc. | DLP Coronary Ostial Cannulae | K263596 |
| Oct 28, 2026 | Tornier, Inc. | Tornier Humeral Reconstruction System (HRS) Tuberosity Body | K263583 |
| Oct 28, 2026 | Coloplast Corp. | Luja female | K263512 |
| Oct 27, 2026 | Tactile Medical | Nimbl Pneumatic Compression System | K260586 |
| Oct 20, 2026 | Beckman Coulter, Inc. | Access BNP II | K262597 |
| Oct 19, 2026 | Beckman Coulter, Inc. | Access MeMed BV | K261109 |
| Oct 6, 2026 | Urolution Medical, Inc. | OpenFlo Urinary Catheter | K261141 |
| Sep 21, 2026 | Beckman Coulter, Inc. | Access NT-proBNP | K262109 |
| Sep 17, 2026 | Medtronic, Inc. | Protégé EverFlex Self-expanding Peripheral Stent System | K262913 |
| Sep 17, 2026 | Abbott Medical | EnSite X EP System | K261729 |
| Sep 16, 2026 | Gt Metabolic Solutions, Inc. | GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01) | K261467 |
| Sep 4, 2026 | Piraeus Medical, Inc. | 70 NeuGlide Catheter | K262277 |
| Sep 3, 2026 | Monteris Medical | NeuroBlate System | K262315 |
| Sep 3, 2026 | Marani Health, Inc. | Mcare System (MW-20) | K253673 |
| Aug 28, 2026 | Medtronic, Inc. | LINQ II Insertable Cardiac Monitor (ICM) (LNQ22) | K262735 |
| Aug 27, 2026 | Piraeus Medical, Inc. | 35 Helix Guidewire | K260751 |
| Aug 24, 2026 | Abmrc, LLC | BiWaze Clear System | K260604 |
| Aug 21, 2026 | Medtronic, Inc. | Affera Integrated Mapping System | K262005 |
| Aug 21, 2026 | Boston Scientific | AVVIGO+ Multi-Modality Guidance System | K253692 |
| Aug 12, 2026 | Boston Scientific | EluPro Antibiotic-Eluting BioEnvelope | K262406 |
| Aug 3, 2026 | ACIST Medical Systems, Inc. | VueJect Ultrasound Enhancing Agent Delivery System | K262115 |
- Oct 29, 2026Canon Medical Informatics, Inc.
Vitrea Advanced Visualization, Version 7.16
- Oct 29, 2026Medtronic, Inc.
DLP Coronary Ostial Cannulae
- Oct 28, 2026Tornier, Inc.
Tornier Humeral Reconstruction System (HRS) Tuberosity Body
- Oct 28, 2026Coloplast Corp.
Luja female
- Oct 27, 2026Tactile Medical
Nimbl Pneumatic Compression System
- Oct 20, 2026Beckman Coulter, Inc.
Access BNP II
- Oct 19, 2026Beckman Coulter, Inc.
Access MeMed BV
- Oct 6, 2026Urolution Medical, Inc.
OpenFlo Urinary Catheter
- Sep 21, 2026Beckman Coulter, Inc.
Access NT-proBNP
- Sep 17, 2026Medtronic, Inc.
Protégé EverFlex Self-expanding Peripheral Stent System
- Sep 17, 2026Abbott Medical
EnSite X EP System
- Sep 16, 2026Gt Metabolic Solutions, Inc.
GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01)
- Sep 4, 2026Piraeus Medical, Inc.
70 NeuGlide Catheter
- Sep 3, 2026Monteris Medical
NeuroBlate System
- Sep 3, 2026Marani Health, Inc.
Mcare System (MW-20)
- Aug 28, 2026Medtronic, Inc.
LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)
- Aug 27, 2026Piraeus Medical, Inc.
35 Helix Guidewire
- Aug 24, 2026Abmrc, LLC
BiWaze Clear System
- Aug 21, 2026Medtronic, Inc.
Affera Integrated Mapping System
- Aug 21, 2026Boston Scientific
AVVIGO+ Multi-Modality Guidance System
- Aug 12, 2026Boston Scientific
EluPro Antibiotic-Eluting BioEnvelope
- Aug 3, 2026ACIST Medical Systems, Inc.
VueJect Ultrasound Enhancing Agent Delivery System
Source: FDA public records. The K number is in Whimbrel's corpus, and the company, device, state, product code and review panel are the openFDA 510(k) fields for that K number. FDA data through October 30, 2026. Each K number links to the FDA record. openFDA data are not validated by the FDA for medical decisions. Check the FDA record before you rely on a row. openFDA 510(k) API. FDA 510(k) database.
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