Data / FDA device clearances / Ohio
FDA device clearances in Ohio: 101 since Nov 2024
The full list. FDA device clearances for applicants in Ohio: 101 rows for $5.05, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. The list gains about 3 rows a month. The new rows come each week by email, $19 a month.
Pay by card with no account. Prices exclude VAT. CSV and Excel files with the columns this page does not show (pathway, device name, applicant address, contact, date received, device type and 5 more), which open on your screen as soon as the payment clears and come by email. The weekly rows run until you cancel, from the link in each delivery. The rows on this page are a sample.
For agents and scripts: this list is ordered at https://specstream.ai/data/fda-clearances/state/ohio, and every list with its row count and price is at https://specstream.ai/data/lists.json.
Updated October 29, 2026. Source: openFDA device 510(k) and PMA (U.S. Food and Drug Administration).
FDA made 101 device decisions for applicants in Ohio from November 12, 2024 to October 29, 2026: 87 510(k) clearances and De Novo grants and 14 PMA approvals and supplements, for 48 applicants. The newest, K263530 on October 29, 2026, is V-Pro maX 2 Low Temperature Sterilization System from Steris.
The request: Every new FDA device clearance or approval for a company in Ohio, with its address, the device and the product code. $10 of credit on sign-up, no card.
SpecStream is the live web data engine for teams and agents. It reads every new FDA device clearance and approval as openFDA publishes it, and this page is that reading. Ask for the specialties, product codes or states you follow and each new decision arrives in your sheet, CRM, Slack or agent with the applicant and its address.
- 101Decisions
- 87510(k) and De Novo
- 14PMA
- October 29, 2026Latest decision
Newest decisions
The newest 100 of 101, each linked to its FDA record. The full list adds the applicant's address, the 510(k) contact as FDA prints it, the device class and the date received.
| Decision date | Number | Device | Applicant | Location | Decision | Type | Product code | Source |
|---|---|---|---|---|---|---|---|---|
| October 29, 2026 | K263530 | V-Pro maX 2 Low Temperature Sterilization System | Steris | Ohio | Substantially Equivalent | 510(k) special | MLR | accessdata.fda.gov |
| October 28, 2026 | K260822 | VERIFY RESI-TEST SWAB Protein Detection Indicator | Steris | Ohio | Substantially Equivalent | 510(k) traditional | SDC | accessdata.fda.gov |
| October 26, 2026 | K261763 | MIM KineticID | Mim Software, Inc. | Ohio | Substantially Equivalent | 510(k) traditional | LLZ | accessdata.fda.gov |
| October 21, 2026 | K263319 | ACHM30 AtriClip FLEX-Mini LAA Exclusion System | AtriCure, Inc. | Ohio | Substantially Equivalent | 510(k) special | PZX | accessdata.fda.gov |
| October 20, 2026 | K260708 | Vein360 Reprocessed LithoVue Digital Flexible Ureteroscope (Standard Deflection); Vein360 Reprocessed... | Vein 360 | Ohio | Substantially Equivalent | 510(k) traditional | FGB | accessdata.fda.gov |
| October 2, 2026 | K261791 | MEDIVATORS ADVANTAGE NXT Automated Endoscope Reprocessor | Steris | Ohio | Substantially Equivalent | 510(k) traditional | FEB | accessdata.fda.gov |
| October 1, 2026 | K263016 | Intra-Operative Positioning System (IOPS) and IOPS Visionary System | Centerline Biomedical | Ohio | Substantially Equivalent | 510(k) special | DQK | accessdata.fda.gov |
| September 24, 2026 | P200002/S015 | EPi- Sense ST Coagulation System | AtriCure, Inc. | Ohio | 30-day notice accepted | PMA 30-day notice | OCM | accessdata.fda.gov |
| September 24, 2026 | P100046/S021 | Synergy Ablation System | AtriCure, Inc. | Ohio | 30-day notice accepted | PMA 30-day notice | OCM | accessdata.fda.gov |
| September 3, 2026 | K251794 | Tenax® Laser Resistant Endotracheal Tube | Bryan Medical, Inc. | Ohio | Substantially Equivalent | 510(k) traditional | BTR | accessdata.fda.gov |
| August 27, 2026 | K260870 | Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) | Gebauer Company | Ohio | Substantially Equivalent | 510(k) traditional | MLY | accessdata.fda.gov |
| July 28, 2026 | P200048/S001 | IsoPSA® Assay | Cleveland Diagnostics, Inc. | Ohio | Approved | PMA real-time process supplement | QRF | accessdata.fda.gov |
| July 16, 2026 | K261309 | Palisades Buttress Plate System | Bethesda Medical Devices, LLC | Ohio | Substantially Equivalent | 510(k) traditional | KWQ | accessdata.fda.gov |
| July 15, 2026 | K260050 | WRAP System | Huneo, LLC | Ohio | Substantially Equivalent | 510(k) traditional | MNR | accessdata.fda.gov |
| July 8, 2026 | K262300 | Denture Base Resin V2 | Formlabs Ohio, Inc. | Ohio | Substantially Equivalent | 510(k) abbreviated | EBI | accessdata.fda.gov |
| June 24, 2026 | K261055 | AMSCO 700 Steam Sterilizer | STERIS Corporation | Ohio | Substantially Equivalent | 510(k) traditional | FLE | accessdata.fda.gov |
| June 18, 2026 | K251559 | InstaTRU Instant Biological Indicator for Steam (IBI-05) | True Indicating, LLC | Ohio | Substantially Equivalent | 510(k) traditional | QVB | accessdata.fda.gov |
| June 12, 2026 | K253196 | Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400) | Midmark Corporation | Ohio | Substantially Equivalent | 510(k) traditional | MWI | accessdata.fda.gov |
| June 10, 2026 | K261329 | Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter, 75cm (C00751);IOPS... | Centerline Biomedical | Ohio | Substantially Equivalent | 510(k) special | DQK | accessdata.fda.gov |
| June 5, 2026 | K243192 | iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating | Nextstep Arthopedix, LLC | Ohio | Substantially Equivalent | 510(k) traditional | LPH | accessdata.fda.gov |
| June 1, 2026 | K261541 | VisionAir Enhanced Stock Stent | VisionAir Solutions | Ohio | Substantially Equivalent | 510(k) special | NWA | accessdata.fda.gov |
| May 19, 2026 | K254024 | MR5 Activ Pro | Multi Radiance Medical, Inc. | Ohio | Substantially Equivalent | 510(k) traditional | NHN | accessdata.fda.gov |
| May 6, 2026 | P200002/S014 | EPi-Sense and EPi-Sense ST Guided Coagulation System | AtriCure, Inc. | Ohio | Approved | PMA special supplement | OCM | accessdata.fda.gov |
| May 6, 2026 | P100046/S020 | Synergy Ablation System | AtriCure, Inc. | Ohio | Approved | PMA special supplement | OCM | accessdata.fda.gov |
| May 4, 2026 | K252622 | Male Latex Condom HA | Okamoto USA, Inc. | Ohio | Substantially Equivalent | 510(k) abbreviated | HIS | accessdata.fda.gov |
| May 1, 2026 | DEN240075 | Prolystica Pass Thru Disinfectant Wipes | Steris | Ohio | Unknown | De Novo | SHM | accessdata.fda.gov |
| April 14, 2026 | K240974 | SPRINT PNS System | Spr Therapeutics, Inc. | Ohio | Substantially Equivalent | 510(k) traditional | SCN | accessdata.fda.gov |
| April 8, 2026 | K260766 | Celerity 5 HP Biological Indicator (LCB052) | STERIS Corporation | Ohio | Substantially Equivalent | 510(k) special | FRC | accessdata.fda.gov |
| April 8, 2026 | K251666 | SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant... | STERIS Corporation | Ohio | Substantially Equivalent | 510(k) traditional | MED | accessdata.fda.gov |
| April 6, 2026 | K253025 | Ricoh 3D for Healthcare Bolus | Ricoh 3D For Healthcare, LLC | Ohio | Substantially Equivalent | 510(k) traditional | IXI | accessdata.fda.gov |
| April 1, 2026 | K242303 | MOD-C | Orthomod, LLC | Ohio | Substantially Equivalent | 510(k) traditional | ODP | accessdata.fda.gov |
| March 27, 2026 | K253270 | Contour ProtégéAI+ | Mim Software, Inc. | Ohio | Substantially Equivalent | 510(k) traditional | QKB | accessdata.fda.gov |
| March 4, 2026 | K260365 | Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima MR Dual... | Devicor Medical Products, Inc. | Ohio | Substantially Equivalent | 510(k) traditional | KNW | accessdata.fda.gov |
| March 4, 2026 | K253871 | Klär Lite (RCW-KL1000) | Radcliffe Watts, LLC | Ohio | Substantially Equivalent | 510(k) traditional | FTC | accessdata.fda.gov |
| February 17, 2026 | K254089 | IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Simple... | Centerline Biomedical, Inc. | Ohio | Substantially Equivalent | 510(k) traditional | DQK | accessdata.fda.gov |
| February 3, 2026 | K252438 | Explant Express | Applied Medical Technology, Inc. | Ohio | Substantially Equivalent | 510(k) traditional | QVS | accessdata.fda.gov |
| January 26, 2026 | K253499 | Ascent3T Neonatal Magnetic Resonance Imaging System | Eyas Medical Imaging, Inc. | Ohio | Substantially Equivalent | 510(k) traditional | LNH | accessdata.fda.gov |
| January 23, 2026 | K253761 | HydroMARK Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK Plus Breast Biopsy Site Marker... | Devicor Medical Products, Inc. | Ohio | Substantially Equivalent | 510(k) traditional | NEU | accessdata.fda.gov |
| January 23, 2026 | K253738 | 3.0T AIR 32CH HNA | Ge Healthcare Coils (Usa Instruments, Inc.) | Ohio | Substantially Equivalent | 510(k) abbreviated | MOS | accessdata.fda.gov |
| January 16, 2026 | P100049/S041 | LINX Reflux Management System | Torax Medical | Ohio | 30-day notice accepted | PMA 30-day notice | LEI | accessdata.fda.gov |
| January 16, 2026 | P100049/S040 | LINX Reflux Management System | Torax Medical | Ohio | 30-day notice accepted | PMA 30-day notice | LEI | accessdata.fda.gov |
| December 31, 2025 | K243627 | Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC) | Arc Trauma, LLC | Ohio | Substantially Equivalent | 510(k) traditional | DXC | accessdata.fda.gov |
| December 11, 2025 | K251883 | MIM LesionID Pro | Mim Software, Inc. | Ohio | Substantially Equivalent | 510(k) traditional | LLZ | accessdata.fda.gov |
| November 28, 2025 | P200048 | IsoPSA Assay | Cleveland Diagnostics, Inc. | Ohio | Approved | PMA original approval | QRF | accessdata.fda.gov |
| November 26, 2025 | DEN240077 | MuReva OM | Mureva Phototherapy, Inc. | Ohio | Unknown | De Novo | SGQ | accessdata.fda.gov |
| November 14, 2025 | P200002/S013 | EPi-Sense ST Coagulation System | AtriCure, Inc. | Ohio | Approved | PMA real-time process supplement | OCM | accessdata.fda.gov |
| November 3, 2025 | K251626 | Midmark Dental Delivery System | Midmark Corporation | Ohio | Substantially Equivalent | 510(k) traditional | EIA | accessdata.fda.gov |
| October 8, 2025 | P100049/S038 | LINX Reflux Management System | Torax Medical | Ohio | Approved | PMA 180-day supplement | LEI | accessdata.fda.gov |
| October 7, 2025 | P200002/S012 | EPi-Sense Guided Coagulation System | AtriCure, Inc. | Ohio | Approved | PMA 180-day supplement | OCM | accessdata.fda.gov |
| October 3, 2025 | K250073 | Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 | Tosoh Bioscience, Inc. | Ohio | Substantially Equivalent | 510(k) traditional | PDJ | accessdata.fda.gov |
| September 29, 2025 | K252054 | SpineAR SNAP (SyncAR Spine) | Surgical Theater, Inc. | Ohio | Substantially Equivalent | 510(k) traditional | SBF | accessdata.fda.gov |
| September 25, 2025 | K252062 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of... | Thermo Fisher Scientific | Ohio | Substantially Equivalent | 510(k) traditional | JWY | accessdata.fda.gov |
| September 25, 2025 | K251791 | Auxano® Wedge Fixation System | Auxano Medical, LLC | Ohio | Substantially Equivalent | 510(k) traditional | PLF | accessdata.fda.gov |
| September 24, 2025 | K252680 | Celerity 20 HP Biological Indicator | STERIS Corporation | Ohio | Substantially Equivalent | 510(k) special | FRC | accessdata.fda.gov |
| September 5, 2025 | K250575 | The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution... | Thermo Fisher Scientific | Ohio | Substantially Equivalent | 510(k) traditional | JWY | accessdata.fda.gov |
| August 28, 2025 | K252014 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of... | Thermo Fisher Scientific | Ohio | Substantially Equivalent | 510(k) traditional | JWY | accessdata.fda.gov |
| August 5, 2025 | K252113 | PRADO Lumbar Interbody Fusion System | Bethesda Medical Devices | Ohio | Substantially Equivalent | 510(k) special | MAX | accessdata.fda.gov |
| August 4, 2025 | K250950 | CUTIVA Topical Skin Adhesive (RM1700); CUTIVA PLUS Skin Closure System (RM1739) | Okapi Medical, LLC Dba Resivant Medical | Ohio | Substantially Equivalent | 510(k) traditional | MPN | accessdata.fda.gov |
| July 24, 2025 | K252056 | Isolator® Synergy EnCompass Clamp and Guide system (OLH, OSH, GPM100) | AtriCure, Inc. | Ohio | Substantially Equivalent | 510(k) special | OCL | accessdata.fda.gov |
| July 11, 2025 | K251352 | Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series... | Codonics.Incorporated | Ohio | Substantially Equivalent | 510(k) traditional | BSZ | accessdata.fda.gov |
| June 30, 2025 | K250990 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of... | Thermo Fisher Scientific | Ohio | Substantially Equivalent | 510(k) traditional | JWY | accessdata.fda.gov |
| June 20, 2025 | K242843 | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint... | Thermo Fisher Scientific | Ohio | Substantially Equivalent | 510(k) traditional | JWY | accessdata.fda.gov |
| June 17, 2025 | P200002/S011 | EPi-Sense Guided Coagulation System | AtriCure, Inc. | Ohio | Approved | PMA 180-day supplement | OCM | accessdata.fda.gov |
| June 17, 2025 | P100046/S019 | Synergy Ablation System | AtriCure, Inc. | Ohio | Approved | PMA 180-day supplement | OCM | accessdata.fda.gov |
| June 6, 2025 | K251452 | Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological... | Steris | Ohio | Substantially Equivalent | 510(k) special | FRC | accessdata.fda.gov |
| June 5, 2025 | K242704 | Synchrony (20-3000) | Synapse Biomedical, Inc. | Ohio | Substantially Equivalent | 510(k) traditional | GZI | accessdata.fda.gov |
| June 4, 2025 | K250259 | TeleRehab Aermos Cardiopulmonary Rehabilitation | The ScottCare Corporation | Ohio | Substantially Equivalent | 510(k) traditional | DRG | accessdata.fda.gov |
| May 22, 2025 | K242659 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of... | Thermo Fisher Scientific | Ohio | Substantially Equivalent | 510(k) traditional | JWY | accessdata.fda.gov |
| May 8, 2025 | K242410 | NextStep Arthropedix Total Knee System | Nextstep Arthropedix | Ohio | Substantially Equivalent | 510(k) traditional | JWH | accessdata.fda.gov |
| May 2, 2025 | K251048 | Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 | STERIS Corporation | Ohio | Substantially Equivalent | 510(k) special | JOJ | accessdata.fda.gov |
| May 1, 2025 | K250029 | ONE TRAY® Sealed Sterilization Container System | Innovative Sterilization Technologies | Ohio | Substantially Equivalent | 510(k) traditional | KCT | accessdata.fda.gov |
| April 25, 2025 | K243876 | VERIFY STEAM Integrating Indicator | STERIS Corporation | Ohio | Substantially Equivalent | 510(k) special | JOJ | accessdata.fda.gov |
| April 18, 2025 | K250842 | PADLOCK CLIP EFTR Kit (00713229) | STERIS Corporation | Ohio | Substantially Equivalent | 510(k) special | PKL | accessdata.fda.gov |
| April 15, 2025 | K242773 | Electro Lube NXT | Steris | Ohio | Substantially Equivalent | 510(k) traditional | GEI | accessdata.fda.gov |
| April 15, 2025 | K242658 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxacin in the dilution range of... | Thermo Fisher Scientific | Ohio | Substantially Equivalent | 510(k) traditional | JWY | accessdata.fda.gov |
| April 10, 2025 | K250371 | cryoICE cryoXT cryoablation probe (cryoXT) | AtriCure, Inc. | Ohio | Substantially Equivalent | 510(k) traditional | GXH | accessdata.fda.gov |
| March 20, 2025 | K243922 | Revogene | Meridian Bioscience, Inc. | Ohio | Substantially Equivalent | 510(k) traditional | OOI | accessdata.fda.gov |
| March 6, 2025 | K243842 | Intra-Operative Positioning System (IOPS®) | Centerline Biomedical, Inc. | Ohio | Substantially Equivalent | 510(k) traditional | DQK | accessdata.fda.gov |
| March 3, 2025 | P200002/S010 | EPi-Sense and EPi-Sense ST Guided Coagulation System | AtriCure, Inc. | Ohio | Approved | PMA special supplement | OCM | accessdata.fda.gov |
| February 28, 2025 | K244054 | 16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247) | Quality Electrodynamics | Ohio | Substantially Equivalent | 510(k) traditional | MOS | accessdata.fda.gov |
| February 27, 2025 | K250021 | Rotium | Nanofiber Solutions, LLC | Ohio | Substantially Equivalent | 510(k) traditional | OWW | accessdata.fda.gov |
| February 27, 2025 | K243738 | The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL | Thermo Fisher Scientific | Ohio | Substantially Equivalent | 510(k) traditional | NGZ | accessdata.fda.gov |
| February 20, 2025 | K250140 | Defendo Fujifilm 700 Single Use Cleaning Adapter | Steris Corparation | Ohio | Substantially Equivalent | 510(k) special | ODC | accessdata.fda.gov |
| February 18, 2025 | K243584 | 0.04 ZERO ZERO FOUR Male Latex Condom | Okamoto USA, Inc. | Ohio | Substantially Equivalent | 510(k) abbreviated | HIS | accessdata.fda.gov |
| February 12, 2025 | K242006 | SureWave Elastography (Q7000225) | Quality Electrodynamics, LLC | Ohio | Substantially Equivalent | 510(k) traditional | LNH | accessdata.fda.gov |
| February 10, 2025 | K243201 | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint... | Thermo Fisher Scientific | Ohio | Substantially Equivalent | 510(k) traditional | JWY | accessdata.fda.gov |
| February 10, 2025 | K242905 | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint... | Thermo Fisher Scientific | Ohio | Substantially Equivalent | 510(k) traditional | JWY | accessdata.fda.gov |
| February 6, 2025 | K250061 | Celerity Incubator | STERIS Corporation | Ohio | Substantially Equivalent | 510(k) special | FRC | accessdata.fda.gov |
| February 6, 2025 | K250044 | Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological... | STERIS Corporation | Ohio | Substantially Equivalent | 510(k) special | FRC | accessdata.fda.gov |
| February 3, 2025 | K250035 | Contour ProtégéAI+ | Mim Software, Inc. | Ohio | Substantially Equivalent | 510(k) special | QKB | accessdata.fda.gov |
| January 17, 2025 | K243067 | The ETHICON Total Energy System | Ethicon Endo-Surgery, LLC (A Johnson and Johnson Company) | Ohio | Substantially Equivalent | 510(k) traditional | GEI | accessdata.fda.gov |
| January 17, 2025 | K242860 | Type 5 Integrating Indicator for Steam (CSPN-15) | True Indicating, LLC | Ohio | Substantially Equivalent | 510(k) traditional | JOJ | accessdata.fda.gov |
| January 15, 2025 | K243860 | AtriClip PRO-Mini LAA Exclusion System (PROM) | AtriCure, Inc. | Ohio | Substantially Equivalent | 510(k) special | PZX | accessdata.fda.gov |
| December 24, 2024 | K243623 | SpineAR SNAP (SyncAR Spine) | Surgical Theater, Inc. | Ohio | Substantially Equivalent | 510(k) special | SBF | accessdata.fda.gov |
| December 19, 2024 | K243169 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of... | Thermo Fisher Scientific | Ohio | Substantially Equivalent | 510(k) traditional | JWY | accessdata.fda.gov |
| December 5, 2024 | K242653 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of... | Thermo Fisher Scientific | Ohio | Substantially Equivalent | 510(k) traditional | JWY | accessdata.fda.gov |
| December 4, 2024 | K243475 | Chemical Indicator for enspire CLCSPS (LCC015) | STERIS Corporation | Ohio | Substantially Equivalent | 510(k) special | JOJ | accessdata.fda.gov |
| December 3, 2024 | K242188 | ClearRead CT CAC | Riverain Technologies, Inc. | Ohio | Substantially Equivalent | 510(k) traditional | JAK | accessdata.fda.gov |
| December 2, 2024 | K243433 | enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System | STERIS Corporation | Ohio | Substantially Equivalent | 510(k) special | FEB | accessdata.fda.gov |
| November 26, 2024 | K242657 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Daptomycin in the dilution range of... | Thermo Fisher Scientific | Ohio | Substantially Equivalent | 510(k) traditional | JWY | accessdata.fda.gov |
Applicants with the most decisions
| Applicant | Decisions | Latest |
|---|---|---|
| AtriCure, Inc. | 13 | October 21, 2026 |
| Thermo Fisher Scientific | 13 | September 25, 2025 |
| STERIS Corporation | 11 | June 24, 2026 |
| Steris | 7 | October 29, 2026 |
| Mim Software, Inc. | 4 | October 26, 2026 |
| Torax Medical | 3 | January 16, 2026 |
| Centerline Biomedical | 2 | October 1, 2026 |
| Cleveland Diagnostics, Inc. | 2 | July 28, 2026 |
| True Indicating, LLC | 2 | June 18, 2026 |
| Midmark Corporation | 2 | June 12, 2026 |
| Okamoto USA, Inc. | 2 | May 4, 2026 |
| Devicor Medical Products, Inc. | 2 | March 4, 2026 |
| Centerline Biomedical, Inc. | 2 | February 17, 2026 |
| Surgical Theater, Inc. | 2 | September 29, 2025 |
| Vein 360 | 1 | October 20, 2026 |
| Bryan Medical, Inc. | 1 | September 3, 2026 |
| Gebauer Company | 1 | August 27, 2026 |
| Bethesda Medical Devices, LLC | 1 | July 16, 2026 |
| Huneo, LLC | 1 | July 15, 2026 |
| Formlabs Ohio, Inc. | 1 | July 8, 2026 |
By panel
| Panel | Decisions | Latest |
|---|---|---|
| General Hospital | 17 | October 29, 2026 |
| Cardiovascular | 16 | October 1, 2026 |
| Microbiology | 13 | September 25, 2025 |
| General, Plastic Surgery | 11 | October 21, 2026 |
| Radiology | 10 | October 26, 2026 |
| Gastroenterology, Urology | 9 | October 20, 2026 |
| Orthopedic | 6 | July 16, 2026 |
| Neurology | 5 | April 14, 2026 |
| Anesthesiology | 3 | September 3, 2026 |
| Dental | 3 | July 8, 2026 |
| Immunology | 2 | July 28, 2026 |
| Obstetrics/Gynecology | 2 | May 4, 2026 |
| Clinical Chemistry | 2 | October 3, 2025 |
| Unknown | 1 | August 27, 2026 |
| Physical Medicine | 1 | May 19, 2026 |
By decision type
| Decision type | Decisions | Latest |
|---|---|---|
| 510(k) traditional | 59 | October 28, 2026 |
| 510(k) special | 21 | October 29, 2026 |
| PMA 30-day notice | 4 | September 24, 2026 |
| 510(k) abbreviated | 4 | July 8, 2026 |
| PMA 180-day supplement | 4 | October 8, 2025 |
| PMA special supplement | 3 | May 6, 2026 |
| De Novo | 3 | May 1, 2026 |
| PMA real-time process supplement | 2 | July 28, 2026 |
| PMA original approval | 1 | November 28, 2025 |
Where FDA publishes these decisions
CC0 1.0 (openFDA). Decisions are as FDA publishes them in its 510(k) and PMA databases, read through openFDA. A PMA row is the original approval or one supplement. The panel is the FDA advisory committee that reviewed the device. FDA adds decisions to openFDA some weeks after their date, so the newest weeks fill in later. The 510(k) contact is in the full list only, as FDA prints it for the submission. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.