Decisions24
Applicants16
24 premarket notifications (510(k)s) from applicants based in Connecticut were decided by FDA in the last 12 months, newest first. Each row links to FDA's own record.
| Decided | Applicant | Device | Area | Where | Record |
|---|---|---|---|---|---|
| 2026-09-06 | Fidelity BioPharma Co. | KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A) OBP | Neurology | New Haven, Connecticut | K260396 |
| 2026-09-03 | Orthocon, Inc. | Permatage XT Settable Nonabsorbable Hemostatic Bone Putty (OS-PER-1001XT) MTJ | Unknown | Stamford, Connecticut | K262769 |
| 2026-08-19 | CooperSurgical, Inc. | Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum Connection Kit (WVCK) MQG | Obstetrics/Gynecology | Trumbull, Connecticut | K261083 |
| 2026-08-19 | Hyperfine, Inc. | Swoop® Portable MR Imaging® System LNH | Radiology | Guilforf, Connecticut | K262622 |
| 2026-07-28 | Caristo Diagnostics , Ltd. | CaRi-Heart SIU | Cardiovascular | Stamford, Connecticut | DEN250042 |
| 2026-07-15 | Better Diagnostics AI Corp. | Better Diagnostics Dental Assist (BDDA) Version 1.0 MYN | Radiology | Avon, Connecticut | K260851 |
| 2026-07-01 | Covidien, LLC | Tri-Staple 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT) GAG | General Hospital | North Haven, Connecticut | K253527 |
| 2026-06-15 | Spine Wave, Inc. | Dynamo Spinal Cement; Salvo® Spine System PML | Orthopedic | Shelton, Connecticut | K260286 |
| 2026-06-15 | Orthocon, Inc. | Permatage XT Settable Bone Putty GXP | Neurology | Stamford, Connecticut | K261265 |
| 2026-06-03 | Orthocon, Inc. | Permatage Flowable, Settable Hemostatic Bone Paste MTJ | Unknown | Stamford, Connecticut | K261439 |
| 2026-06-03 | Biowave Corporation | BioWave BioWraps GXY | Neurology | Westport, Connecticut | K261522 |
| 2026-05-29 | Spine Wave, Inc. | Exceed® Biplanar Expandable Interbody System MAX | Orthopedic | Shelton, Connecticut | K261159 |
| 2026-05-28 | Medtronic | Trexon Monofilament Synthetic Absorbable Suture GAM | General, Plastic Surgery | North Haven, Connecticut | K253530 |
| 2026-04-28 | ZetrOZ Systems, LLC | SAM 3.0 Multi-Hour Continuous Ultrasound Device PFW | Physical Medicine | Trumbull, Connecticut | K260076 |
| 2026-04-10 | Covidien (Part of Medtronic) | Tri-staple 2.0 Reloads; Endo GIA Reloads with Tri-Staple Technology; Endo GIA Gray Articulating Reloads; Signia Small Diameter Reloads GDW | General, Plastic Surgery | North Haven, Connecticut | K253657 |
| 2026-03-16 | Orthocon, Inc. | Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) GXR | Neurology | Stamford, Connecticut | K253447 |
| 2026-03-13 | Orthocon, Inc. | Permatage Flowable, Settable Bone Paste GXP | Neurology | Stamford, Connecticut | K253732 |
| 2026-01-23 | Elidah, Inc. | Elitone for Men QAJ | Gastroenterology, Urology | Newtown, Connecticut | K253285 |
| 2026-01-20 | Cooper Surgical | Milex Incontinence Dish Pessaries; Milex Incontinence Dish Pessaries with Support; Milex Cube Pessaries; Milex Cube Pessaries with Drainage Holes HHW | Obstetrics/Gynecology | Trumbull, Connecticut | K253698 |
| 2026-01-02 | Orthocon, Inc. | MONTAGE XT Cranial Cement GXP | Neurology | Stamford, Connecticut | K253854 |
| 2025-12-12 | Hyperfine, Inc. | Swoop® Portable MR Imaging® System LNH | Radiology | Guilforf, Connecticut | K253489 |
| 2025-12-04 | Chawla Heart Technologies, LLC | MitraPatch Mitral Valve Repair System PAW | Cardiovascular | Bloomfield, Connecticut | K252126 |
| 2025-12-03 | Covidien, LLC | Hugo RAS System SCV | General, Plastic Surgery | North Haven, Connecticut | K250725 |
| 2025-11-21 | Centrix, Inc. | FluoroDose Varnish LBH | Dental | Shelton, Connecticut | K250714 |
Where this comes from
Before most medical devices can be sold in the United States, the maker submits a premarket notification, a 510(k), and FDA decides whether the device is substantially equivalent to one already on the market. Every row here is one of those decisions, linked to FDA's own record of it. The product area is the medical specialty FDA files the device under; the location is the applicant's, as the submission gives it.
A clearance means the agency found the device substantially equivalent; it is not an endorsement. Where an applicant also files with the SEC under the same name in the same state, it links to that company's page.
Cite this page
Permanent URL:
https://mentionfox.com/fda/510k/state/ctLast updated 2026-10-18
FDA device clearances in Connecticut: 24 510(k) decisions in the last 12 months. MentionFox, 2026-10-18. https://mentionfox.com/fda/510k/state/ct