Decisions33
Applicants26
33 premarket notifications (510(k)s) from applicants based in Ohio 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 |
|---|---|---|---|---|---|
| 2026-10-02 | Steris | MEDIVATORS ADVANTAGE NXT Automated Endoscope Reprocessor FEB | Gastroenterology, Urology | Mentor, Ohio | K261791 |
| 2026-10-01 | Centerline Biomedical | Intra-Operative Positioning System (IOPS) and IOPS Visionary System DQK | Cardiovascular | Warrensville Heights, Ohio | K263016 |
| 2026-09-03 | Bryan Medical, Inc. | Tenax® Laser Resistant Endotracheal Tube BTR | Anesthesiology | Cincinnati, Ohio | K251794 |
| 2026-08-27 | Gebauer Company | Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) MLY | Unknown | Cleveland, Ohio | K260870 |
| 2026-07-16 | Bethesda Medical Devices, LLC | Palisades Buttress Plate System KWQ | Orthopedic | Brunswick, Ohio | K261309 |
| 2026-07-15 | Huneo, LLC | WRAP System MNR | Anesthesiology | Willoughby Hills, Ohio | K260050 |
| 2026-07-08 | Formlabs Ohio, Inc. | Denture Base Resin V2 EBI | Dental | Millbury, Ohio | K262300 |
| 2026-06-24 | STERIS Corporation | AMSCO 700 Steam Sterilizer FLE | General Hospital | Mentor, Ohio | K261055 |
| 2026-06-18 | True Indicating, LLC | InstaTRU Instant Biological Indicator for Steam (IBI-05) QVB | General Hospital | Toledo, Ohio | K251559 |
| 2026-06-12 | Midmark Corporation | Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400) MWI | Cardiovascular | Versailles, Ohio | K253196 |
| 2026-06-10 | Centerline Biomedical | Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter, 75cm (C00751);IOPS Viewpoint Simple Curve Catheter, 125cm (C01251);IOPS Viewpoint Double Curve Catheter, 75cm (C00752);IOPS Viewpoint Double Curve Catheter, 125cm (C02152);IOPS Guidewire 2 (ATW-2);IOPS Fiducial Tracking Pad (T02111);IOPS Guidewire Handle (H01035) DQK | Cardiovascular | Warrensville Heights, Ohio | K261329 |
| 2026-06-05 | Nextstep Arthopedix, LLC | iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating LPH | Orthopedic | Akron, Ohio | K243192 |
| 2026-06-01 | VisionAir Solutions | VisionAir Enhanced Stock Stent NWA | General, Plastic Surgery | Akron, Ohio | K261541 |
| 2026-05-19 | Multi Radiance Medical, Inc. | MR5 Activ Pro NHN | Physical Medicine | Solon, Ohio | K254024 |
| 2026-05-04 | Okamoto USA, Inc. | Male Latex Condom HA HIS | Obstetrics/Gynecology | Sandusky, Ohio | K252622 |
| 2026-05-01 | Steris | Prolystica Pass Thru Disinfectant Wipes SHM | General Hospital | Mentor, Ohio | DEN240075 |
| 2026-04-14 | Spr Therapeutics, Inc. | SPRINT PNS System SCN | Neurology | Cleveland, Ohio | K240974 |
| 2026-04-08 | STERIS Corporation | SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 MED | General Hospital | Mentor, Ohio | K251666 |
| 2026-04-08 | STERIS Corporation | Celerity 5 HP Biological Indicator (LCB052) FRC | General Hospital | Mentor, Ohio | K260766 |
| 2026-04-06 | Ricoh 3D For Healthcare, LLC | Ricoh 3D for Healthcare Bolus IXI | Radiology | Parma, Ohio | K253025 |
| 2026-04-01 | Orthomod, LLC | MOD-C ODP | Orthopedic | Dayton, Ohio | K242303 |
| 2026-03-27 | Mim Software, Inc. | Contour ProtégéAI+ QKB | Radiology | Cleveland, Ohio | K253270 |
| 2026-03-04 | Radcliffe Watts, LLC | Klär Lite (RCW-KL1000) FTC | General, Plastic Surgery | Mansfield, Ohio | K253871 |
| 2026-03-04 | Devicor Medical Products, Inc. | Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Foot Switch; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Reusable Tray; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Battery Char KNW | Gastroenterology, Urology | Cincinnati, Ohio | K260365 |
| 2026-02-17 | Centerline Biomedical, Inc. | IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Simple Curve Catheter, 125cm (C01251); IOPS Viewpoint Double Curve Catheter, 75cm (C00752); IOPS Viewpoint Double Curve Catheter, 125cm (C02152); IOPS Guidewire 2 (ATW-2); IOPS Fiducial Tracking Pad (T02111); IOPS Guidewire Handle (H01035) DQK | Cardiovascular | Cleveland, Ohio | K254089 |
| 2026-02-03 | Applied Medical Technology, Inc. | Explant Express QVS | General, Plastic Surgery | Brecksville, Ohio | K252438 |
| 2026-01-26 | Eyas Medical Imaging, Inc. | Ascent3T Neonatal Magnetic Resonance Imaging System LNH | Radiology | Cincinnati, Ohio | K253499 |
| 2026-01-23 | Ge Healthcare Coils (Usa Instruments, Inc.) | 3.0T AIR 32CH HNA MOS | Radiology | Aurora, Ohio | K253738 |
| 2026-01-23 | Devicor Medical Products, Inc. | HydroMARK Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape) NEU | General, Plastic Surgery | Cincinnati, Ohio | K253761 |
| 2025-12-31 | Arc Trauma, LLC | Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC) DXC | Cardiovascular | Jamestown, Ohio | K243627 |
| 2025-12-11 | Mim Software, Inc. | MIM LesionID Pro LLZ | Radiology | Cleveland, Ohio | K251883 |
| 2025-11-26 | Mureva Phototherapy, Inc. | MuReva OM SGQ | Dental | Strongsville, Ohio | DEN240077 |
| 2025-11-03 | Midmark Corporation | Midmark Dental Delivery System EIA | Dental | Versailles, Ohio | K251626 |
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/ohLast updated 2026-10-18
FDA device clearances in Ohio: 33 510(k) decisions in the last 12 months. MentionFox, 2026-10-18. https://mentionfox.com/fda/510k/state/oh