Skip to the page

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 dateNumberDeviceApplicantLocationDecisionTypeProduct codeSource
October 29, 2026K263530V-Pro maX 2 Low Temperature Sterilization SystemSterisOhioSubstantially Equivalent510(k) specialMLRaccessdata.fda.gov
October 28, 2026K260822VERIFY RESI-TEST SWAB Protein Detection IndicatorSterisOhioSubstantially Equivalent510(k) traditionalSDCaccessdata.fda.gov
October 26, 2026K261763MIM – KineticIDMim Software, Inc.OhioSubstantially Equivalent510(k) traditionalLLZaccessdata.fda.gov
October 21, 2026K263319ACHM30 AtriClip FLEX-Mini LAA Exclusion SystemAtriCure, Inc.OhioSubstantially Equivalent510(k) specialPZXaccessdata.fda.gov
October 20, 2026K260708Vein360 Reprocessed LithoVue Digital Flexible Ureteroscope (Standard Deflection); Vein360 Reprocessed...Vein 360OhioSubstantially Equivalent510(k) traditionalFGBaccessdata.fda.gov
October 2, 2026K261791MEDIVATORS™ ADVANTAGE NXT™ Automated Endoscope ReprocessorSterisOhioSubstantially Equivalent510(k) traditionalFEBaccessdata.fda.gov
October 1, 2026K263016Intra-Operative Positioning System (IOPS) and IOPS Visionary SystemCenterline BiomedicalOhioSubstantially Equivalent510(k) specialDQKaccessdata.fda.gov
September 24, 2026P200002/S015EPi- Sense ST Coagulation SystemAtriCure, Inc.Ohio30-day notice acceptedPMA 30-day noticeOCMaccessdata.fda.gov
September 24, 2026P100046/S021Synergy Ablation SystemAtriCure, Inc.Ohio30-day notice acceptedPMA 30-day noticeOCMaccessdata.fda.gov
September 3, 2026K251794Tenax® Laser Resistant Endotracheal TubeBryan Medical, Inc.OhioSubstantially Equivalent510(k) traditionalBTRaccessdata.fda.gov
August 27, 2026K260870Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)Gebauer CompanyOhioSubstantially Equivalent510(k) traditionalMLYaccessdata.fda.gov
July 28, 2026P200048/S001IsoPSA® AssayCleveland Diagnostics, Inc.OhioApprovedPMA real-time process supplementQRFaccessdata.fda.gov
July 16, 2026K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLCOhioSubstantially Equivalent510(k) traditionalKWQaccessdata.fda.gov
July 15, 2026K260050WRAP SystemHuneo, LLCOhioSubstantially Equivalent510(k) traditionalMNRaccessdata.fda.gov
July 8, 2026K262300Denture Base Resin V2Formlabs Ohio, Inc.OhioSubstantially Equivalent510(k) abbreviatedEBIaccessdata.fda.gov
June 24, 2026K261055AMSCO 700 Steam SterilizerSTERIS CorporationOhioSubstantially Equivalent510(k) traditionalFLEaccessdata.fda.gov
June 18, 2026K251559InstaTRU Instant Biological Indicator for Steam (IBI-05)True Indicating, LLCOhioSubstantially Equivalent510(k) traditionalQVBaccessdata.fda.gov
June 12, 2026K253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark CorporationOhioSubstantially Equivalent510(k) traditionalMWIaccessdata.fda.gov
June 10, 2026K261329Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter, 75cm (C00751);IOPS...Centerline BiomedicalOhioSubstantially Equivalent510(k) specialDQKaccessdata.fda.gov
June 5, 2026K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLCOhioSubstantially Equivalent510(k) traditionalLPHaccessdata.fda.gov
June 1, 2026K261541VisionAir Enhanced Stock StentVisionAir SolutionsOhioSubstantially Equivalent510(k) specialNWAaccessdata.fda.gov
May 19, 2026K254024MR5 Activ ProMulti Radiance Medical, Inc.OhioSubstantially Equivalent510(k) traditionalNHNaccessdata.fda.gov
May 6, 2026P200002/S014EPi-Sense and EPi-Sense ST Guided Coagulation SystemAtriCure, Inc.OhioApprovedPMA special supplementOCMaccessdata.fda.gov
May 6, 2026P100046/S020Synergy Ablation SystemAtriCure, Inc.OhioApprovedPMA special supplementOCMaccessdata.fda.gov
May 4, 2026K252622Male Latex Condom HAOkamoto USA, Inc.OhioSubstantially Equivalent510(k) abbreviatedHISaccessdata.fda.gov
May 1, 2026DEN240075Prolystica Pass Thru Disinfectant WipesSterisOhioUnknownDe NovoSHMaccessdata.fda.gov
April 14, 2026K240974SPRINT PNS SystemSpr Therapeutics, Inc.OhioSubstantially Equivalent510(k) traditionalSCNaccessdata.fda.gov
April 8, 2026K260766Celerity 5 HP Biological Indicator (LCB052)STERIS CorporationOhioSubstantially Equivalent510(k) specialFRCaccessdata.fda.gov
April 8, 2026K251666SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant...STERIS CorporationOhioSubstantially Equivalent510(k) traditionalMEDaccessdata.fda.gov
April 6, 2026K253025Ricoh 3D for Healthcare BolusRicoh 3D For Healthcare, LLCOhioSubstantially Equivalent510(k) traditionalIXIaccessdata.fda.gov
April 1, 2026K242303MOD-COrthomod, LLCOhioSubstantially Equivalent510(k) traditionalODPaccessdata.fda.gov
March 27, 2026K253270Contour ProtégéAI+Mim Software, Inc.OhioSubstantially Equivalent510(k) traditionalQKBaccessdata.fda.gov
March 4, 2026K260365Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima™ MR Dual...Devicor Medical Products, Inc.OhioSubstantially Equivalent510(k) traditionalKNWaccessdata.fda.gov
March 4, 2026K253871Klär Lite (RCW-KL1000)Radcliffe Watts, LLCOhioSubstantially Equivalent510(k) traditionalFTCaccessdata.fda.gov
February 17, 2026K254089IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Simple...Centerline Biomedical, Inc.OhioSubstantially Equivalent510(k) traditionalDQKaccessdata.fda.gov
February 3, 2026K252438Explant ExpressApplied Medical Technology, Inc.OhioSubstantially Equivalent510(k) traditionalQVSaccessdata.fda.gov
January 26, 2026K253499Ascent3T Neonatal Magnetic Resonance Imaging SystemEyas Medical Imaging, Inc.OhioSubstantially Equivalent510(k) traditionalLNHaccessdata.fda.gov
January 23, 2026K253761HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker...Devicor Medical Products, Inc.OhioSubstantially Equivalent510(k) traditionalNEUaccessdata.fda.gov
January 23, 2026K2537383.0T AIR 32CH HNAGe Healthcare Coils (Usa Instruments, Inc.)OhioSubstantially Equivalent510(k) abbreviatedMOSaccessdata.fda.gov
January 16, 2026P100049/S041LINX Reflux Management SystemTorax MedicalOhio30-day notice acceptedPMA 30-day noticeLEIaccessdata.fda.gov
January 16, 2026P100049/S040LINX™ Reflux Management SystemTorax MedicalOhio30-day notice acceptedPMA 30-day noticeLEIaccessdata.fda.gov
December 31, 2025K243627Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)Arc Trauma, LLCOhioSubstantially Equivalent510(k) traditionalDXCaccessdata.fda.gov
December 11, 2025K251883MIM – LesionID ProMim Software, Inc.OhioSubstantially Equivalent510(k) traditionalLLZaccessdata.fda.gov
November 28, 2025P200048IsoPSA AssayCleveland Diagnostics, Inc.OhioApprovedPMA original approvalQRFaccessdata.fda.gov
November 26, 2025DEN240077MuReva OM™Mureva Phototherapy, Inc.OhioUnknownDe NovoSGQaccessdata.fda.gov
November 14, 2025P200002/S013EPi-Sense ST Coagulation SystemAtriCure, Inc.OhioApprovedPMA real-time process supplementOCMaccessdata.fda.gov
November 3, 2025K251626Midmark Dental Delivery SystemMidmark CorporationOhioSubstantially Equivalent510(k) traditionalEIAaccessdata.fda.gov
October 8, 2025P100049/S038LINX Reflux Management SystemTorax MedicalOhioApprovedPMA 180-day supplementLEIaccessdata.fda.gov
October 7, 2025P200002/S012EPi-Sense Guided Coagulation SystemAtriCure, Inc.OhioApprovedPMA 180-day supplementOCMaccessdata.fda.gov
October 3, 2025K250073Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01Tosoh Bioscience, Inc.OhioSubstantially Equivalent510(k) traditionalPDJaccessdata.fda.gov
September 29, 2025K252054SpineAR SNAP (SyncAR Spine)Surgical Theater, Inc.OhioSubstantially Equivalent510(k) traditionalSBFaccessdata.fda.gov
September 25, 2025K252062The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of...Thermo Fisher ScientificOhioSubstantially Equivalent510(k) traditionalJWYaccessdata.fda.gov
September 25, 2025K251791Auxano® Wedge Fixation SystemAuxano Medical, LLCOhioSubstantially Equivalent510(k) traditionalPLFaccessdata.fda.gov
September 24, 2025K252680Celerity™ 20 HP Biological IndicatorSTERIS CorporationOhioSubstantially Equivalent510(k) specialFRCaccessdata.fda.gov
September 5, 2025K250575The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution...Thermo Fisher ScientificOhioSubstantially Equivalent510(k) traditionalJWYaccessdata.fda.gov
August 28, 2025K252014The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of...Thermo Fisher ScientificOhioSubstantially Equivalent510(k) traditionalJWYaccessdata.fda.gov
August 5, 2025K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical DevicesOhioSubstantially Equivalent510(k) specialMAXaccessdata.fda.gov
August 4, 2025K250950CUTIVA™ Topical Skin Adhesive (RM1700); CUTIVA™ PLUS Skin Closure System (RM1739)Okapi Medical, LLC Dba Resivant MedicalOhioSubstantially Equivalent510(k) traditionalMPNaccessdata.fda.gov
July 24, 2025K252056Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100)AtriCure, Inc.OhioSubstantially Equivalent510(k) specialOCLaccessdata.fda.gov
July 11, 2025K251352Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series...Codonics.IncorporatedOhioSubstantially Equivalent510(k) traditionalBSZaccessdata.fda.gov
June 30, 2025K250990The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of...Thermo Fisher ScientificOhioSubstantially Equivalent510(k) traditionalJWYaccessdata.fda.gov
June 20, 2025K242843The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint...Thermo Fisher ScientificOhioSubstantially Equivalent510(k) traditionalJWYaccessdata.fda.gov
June 17, 2025P200002/S011EPi-Sense Guided Coagulation SystemAtriCure, Inc.OhioApprovedPMA 180-day supplementOCMaccessdata.fda.gov
June 17, 2025P100046/S019Synergy Ablation SystemAtriCure, Inc.OhioApprovedPMA 180-day supplementOCMaccessdata.fda.gov
June 6, 2025K251452Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological...SterisOhioSubstantially Equivalent510(k) specialFRCaccessdata.fda.gov
June 5, 2025K242704Synchrony (20-3000)Synapse Biomedical, Inc.OhioSubstantially Equivalent510(k) traditionalGZIaccessdata.fda.gov
June 4, 2025K250259TeleRehab Aermos Cardiopulmonary RehabilitationThe ScottCare CorporationOhioSubstantially Equivalent510(k) traditionalDRGaccessdata.fda.gov
May 22, 2025K242659The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of...Thermo Fisher ScientificOhioSubstantially Equivalent510(k) traditionalJWYaccessdata.fda.gov
May 8, 2025K242410NextStep Arthropedix Total Knee SystemNextstep ArthropedixOhioSubstantially Equivalent510(k) traditionalJWHaccessdata.fda.gov
May 2, 2025K251048Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118STERIS CorporationOhioSubstantially Equivalent510(k) specialJOJaccessdata.fda.gov
May 1, 2025K250029ONE TRAY® Sealed Sterilization Container SystemInnovative Sterilization TechnologiesOhioSubstantially Equivalent510(k) traditionalKCTaccessdata.fda.gov
April 25, 2025K243876VERIFY STEAM Integrating IndicatorSTERIS CorporationOhioSubstantially Equivalent510(k) specialJOJaccessdata.fda.gov
April 18, 2025K250842PADLOCK CLIP EFTR Kit (00713229)STERIS CorporationOhioSubstantially Equivalent510(k) specialPKLaccessdata.fda.gov
April 15, 2025K242773Electro Lube NXTSterisOhioSubstantially Equivalent510(k) traditionalGEIaccessdata.fda.gov
April 15, 2025K242658The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxacin in the dilution range of...Thermo Fisher ScientificOhioSubstantially Equivalent510(k) traditionalJWYaccessdata.fda.gov
April 10, 2025K250371cryoICE cryoXT cryoablation probe (cryoXT)AtriCure, Inc.OhioSubstantially Equivalent510(k) traditionalGXHaccessdata.fda.gov
March 20, 2025K243922RevogeneMeridian Bioscience, Inc.OhioSubstantially Equivalent510(k) traditionalOOIaccessdata.fda.gov
March 6, 2025K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc.OhioSubstantially Equivalent510(k) traditionalDQKaccessdata.fda.gov
March 3, 2025P200002/S010EPi-Sense and EPi-Sense ST Guided Coagulation SystemAtriCure, Inc.OhioApprovedPMA special supplementOCMaccessdata.fda.gov
February 28, 2025K24405416ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247)Quality ElectrodynamicsOhioSubstantially Equivalent510(k) traditionalMOSaccessdata.fda.gov
February 27, 2025K250021RotiumNanofiber Solutions, LLCOhioSubstantially Equivalent510(k) traditionalOWWaccessdata.fda.gov
February 27, 2025K243738The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mLThermo Fisher ScientificOhioSubstantially Equivalent510(k) traditionalNGZaccessdata.fda.gov
February 20, 2025K250140Defendo Fujifilm 700 Single Use Cleaning AdapterSteris CorparationOhioSubstantially Equivalent510(k) specialODCaccessdata.fda.gov
February 18, 2025K2435840.04 ZERO ZERO FOUR Male Latex CondomOkamoto USA, Inc.OhioSubstantially Equivalent510(k) abbreviatedHISaccessdata.fda.gov
February 12, 2025K242006SureWave Elastography (Q7000225)Quality Electrodynamics, LLCOhioSubstantially Equivalent510(k) traditionalLNHaccessdata.fda.gov
February 10, 2025K243201The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint...Thermo Fisher ScientificOhioSubstantially Equivalent510(k) traditionalJWYaccessdata.fda.gov
February 10, 2025K242905The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint...Thermo Fisher ScientificOhioSubstantially Equivalent510(k) traditionalJWYaccessdata.fda.gov
February 6, 2025K250061Celerity IncubatorSTERIS CorporationOhioSubstantially Equivalent510(k) specialFRCaccessdata.fda.gov
February 6, 2025K250044Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological...STERIS CorporationOhioSubstantially Equivalent510(k) specialFRCaccessdata.fda.gov
February 3, 2025K250035Contour ProtégéAI+Mim Software, Inc.OhioSubstantially Equivalent510(k) specialQKBaccessdata.fda.gov
January 17, 2025K243067The ETHICON™ Total Energy SystemEthicon Endo-Surgery, LLC (A Johnson and Johnson Company)OhioSubstantially Equivalent510(k) traditionalGEIaccessdata.fda.gov
January 17, 2025K242860Type 5 Integrating Indicator for Steam (CSPN-15)True Indicating, LLCOhioSubstantially Equivalent510(k) traditionalJOJaccessdata.fda.gov
January 15, 2025K243860AtriClip PRO-Mini LAA Exclusion System (PROM)AtriCure, Inc.OhioSubstantially Equivalent510(k) specialPZXaccessdata.fda.gov
December 24, 2024K243623SpineAR SNAP (SyncAR Spine)Surgical Theater, Inc.OhioSubstantially Equivalent510(k) specialSBFaccessdata.fda.gov
December 19, 2024K243169The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of...Thermo Fisher ScientificOhioSubstantially Equivalent510(k) traditionalJWYaccessdata.fda.gov
December 5, 2024K242653The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of...Thermo Fisher ScientificOhioSubstantially Equivalent510(k) traditionalJWYaccessdata.fda.gov
December 4, 2024K243475Chemical Indicator for enspire CLCSPS (LCC015)STERIS CorporationOhioSubstantially Equivalent510(k) specialJOJaccessdata.fda.gov
December 3, 2024K242188ClearRead CT CACRiverain Technologies, Inc.OhioSubstantially Equivalent510(k) traditionalJAKaccessdata.fda.gov
December 2, 2024K243433enspire 3000 Cleaning and Liquid Chemical Sterilant Processing SystemSTERIS CorporationOhioSubstantially Equivalent510(k) specialFEBaccessdata.fda.gov
November 26, 2024K242657The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Daptomycin in the dilution range of...Thermo Fisher ScientificOhioSubstantially Equivalent510(k) traditionalJWYaccessdata.fda.gov

Applicants with the most decisions

ApplicantDecisionsLatest
AtriCure, Inc.13October 21, 2026
Thermo Fisher Scientific13September 25, 2025
STERIS Corporation11June 24, 2026
Steris7October 29, 2026
Mim Software, Inc.4October 26, 2026
Torax Medical3January 16, 2026
Centerline Biomedical2October 1, 2026
Cleveland Diagnostics, Inc.2July 28, 2026
True Indicating, LLC2June 18, 2026
Midmark Corporation2June 12, 2026
Okamoto USA, Inc.2May 4, 2026
Devicor Medical Products, Inc.2March 4, 2026
Centerline Biomedical, Inc.2February 17, 2026
Surgical Theater, Inc.2September 29, 2025
Vein 3601October 20, 2026
Bryan Medical, Inc.1September 3, 2026
Gebauer Company1August 27, 2026
Bethesda Medical Devices, LLC1July 16, 2026
Huneo, LLC1July 15, 2026
Formlabs Ohio, Inc.1July 8, 2026

By panel

PanelDecisionsLatest
General Hospital17October 29, 2026
Cardiovascular16October 1, 2026
Microbiology13September 25, 2025
General, Plastic Surgery11October 21, 2026
Radiology10October 26, 2026
Gastroenterology, Urology9October 20, 2026
Orthopedic6July 16, 2026
Neurology5April 14, 2026
Anesthesiology3September 3, 2026
Dental3July 8, 2026
Immunology2July 28, 2026
Obstetrics/Gynecology2May 4, 2026
Clinical Chemistry2October 3, 2025
Unknown1August 27, 2026
Physical Medicine1May 19, 2026

By decision type

Decision typeDecisionsLatest
510(k) traditional59October 28, 2026
510(k) special21October 29, 2026
PMA 30-day notice4September 24, 2026
510(k) abbreviated4July 8, 2026
PMA 180-day supplement4October 8, 2025
PMA special supplement3May 6, 2026
De Novo3May 1, 2026
PMA real-time process supplement2July 28, 2026
PMA original approval1November 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.