Midmark Corp
Versailles, OH, US
MIDMARK CORP. appears in FDA device records in Versailles, OH. FDA records list 39 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Midmark Corp carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Midmark Corportationrecall
510(k) clearance history
FDA records hold 39 510(k) clearances for Midmark Corp between 1981 and 2026. The busiest year on record is 1989, with 5. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1981 | 2 |
| 1982 | 3 |
| 1983 | 1 |
| 1984 | 1 |
| 1985 | 1 |
| 1989 | 5 |
| 1990 | 2 |
| 1991 | 2 |
| 1992 | 1 |
| 1993 | 2 |
| 1994 | 4 |
| 1999 | 1 |
| 2000 | 2 |
| 2003 | 1 |
| 2009 | 2 |
| 2011 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2020 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253196 | Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400) | MWI | Substantially Equivalent | |
| K251626 | Midmark Dental Delivery System | EIA | Substantially Equivalent | |
| K233026 | Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer | FLE | Substantially Equivalent | |
| K201667 | Midmark Extraoral Imaging System (EOIS) | OAS | Substantially Equivalent | |
| K163337 | Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer | FLE | Substantially Equivalent | |
| K161909 | IQvitals Zone | MWI | Substantially Equivalent | |
| K122643 | VANTAGE MODEL V5000, V5100, V5000C, V5100C | MUH | Substantially Equivalent | |
| K120239 | ELEVANCE | EIA | Substantially Equivalent | |
| K112380 | CLEARVISION | MUH | Substantially Equivalent | |
| K091866 | PROGENY VANTAGE PANORAMIC X-RAY SYSTEM | MUH | Substantially Equivalent | |
| K090670 | MIDMARK M3 ULTRAFAST AUTOMATIC STERILIZER | FLE | Substantially Equivalent | |
| K023348 | MIDMARK M9 ULTRACLAVE STEAM STERILIZER | FLE | Substantially Equivalent | |
| K003090 | MIDMARK PROCENTER INSTRUMENT DELIVERY SYSTEM | EIA | Substantially Equivalent | |
| K992744 | MIDMARK M4*9 EASYCLAVE STEAM STERILIZER | FLE | Substantially Equivalent | |
| K990189 | MODIFICATION OF: MIDMARK M-11 ULTRACLAVE STEAM STERILIZER | FLE | Substantially Equivalent | |
| K936181 | MIDMARK M-11 ULTRACLAVE STEAM STERILIZER | FLE | Substantially Equivalent | |
| K926463 | RITTERMODEL 75 EVOLUTION UNIV POW EXAM TABLE/ACCES | FQO | Substantially Equivalent | |
| K934744 | MIDMARK MAGNUM GENERAL SURGICAL TABLE | GDC | Substantially Equivalent | |
| K923730 | MODEL 561 C-ARM PROCEDURES STRETCHER | FPO | Substantially Equivalent | |
| K932719 | RITTER MODEL 158 AND 159 EXAM LIGHTS | KZF | Substantially Equivalent | |
| K930686 | MIDMARK SURGICAL LIGHTING SYSTEMS | FSQ | Substantially Equivalent | |
| K915141 | 712 PLASTIC SURGERY TABLE & ACCESORIES | FQO | Substantially Equivalent | |
| K911322 | MODEL #M9 ULTRACLAVE STEAM STERILIZER | FLE | Substantially Equivalent | |
| K910781 | #491 POWER OTOLARYNGOLY CH/#498 PROCED CTR & ACCES | ETF | Substantially Equivalent | |
| K904011 | MODEL #527 OPHTHALMIC STRETCHER | FPO | Substantially Equivalent | |
| K900432 | MODEL #M8 ELECTRONIC STERILIZER | FLE | Substantially Equivalent | |
| K894335 | MODEL #535 PACU STRETCHER/BED & #530 ED/TRAUMA STR | FMF | Substantially Equivalent | |
| K895016 | MODEL #510/515 GENERAL TRANSPORT STRETCHER | INW | Substantially Equivalent | |
| K894144 | POWER EXAMINATION TABLE MODEL # 405 | LGX | Substantially Equivalent | |
| K894134 | POWER EXAMINATION TABLE MODEL # 411 | LGX | Substantially Equivalent | |
| K894017 | POWER PODIATRY CHAIR/TABLE #414, #416 & #417 | INQ | Substantially Equivalent | |
| K852422 | MODEL 500 PEDIATRIC STRETCHER/CRIB | FMS | Substantially Equivalent | |
| K841505 | SURGI-MED TABLE MODEL 485-LT | Substantially Equivalent | ||
| K831385 | LITHOTOMY CHAIR #415 | GBB | Substantially Equivalent | |
| K822531 | MULTIPLE, ENT CABINET #448 | ETF | Substantially Equivalent | |
| K822530 | MULTIPLE, ENT CHAIR #418 | ETF | Substantially Equivalent | |
| K820823 | MULTIPLE, MODEL #17 | LGX | Substantially Equivalent | |
| K811190 | THREE MODELS OF TABLES, STOOLS, & LIGHTS | LGX | Substantially Equivalent | |
| K810598 | X-RAY COLLIMATING DEVICES | IZW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3043668257 | 3043668257 | MIDMARK CORP. | 9987 Carver Rd Ste 310, Blue Ash, OH 45242 US | 2026 | |
| 1523530 | 1523530 | MIDMARK CORPORATION | 60 Vista Dr, Versailles, OH 45380 US | 2026 | and 10 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- FMSBed, Pediatric Open Hospital
- NODBoard, Arm (With Cover), Non-Sterile
- FMLChair, Blood Donor
- NRUChair, Dental, Without Operative Unit
- FRKChair, Examination And Treatment
- GBBChair, Surgical, Ac-Powered
- IZWCollimator, Automatic, Radiographic
- KZFDevice, Medical Examination, Ac Powered
- DPSElectrocardiograph
- EAZLight, Operating, Dental
- FSQLight, Surgical, Instrument
- OUGMedical Device Data System
- MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- FMQRestraint, Protective
- FRWScale, Patient
- FOXStand, Infusion
- FLESterilizer, Steam
- FPOStretcher, Wheeled
- FMFSyringe, Piston
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- MUHSystem, X-Ray, Extraoral Source, Digital
- LGXTable, Examination, Medical, Powered
- INWTable, Mechanical
- FQOTable, Operating-Room, Ac-Powered
- GDCTable, Operating-Room, Electrical
- INQTable, Powered
- DRGTransmitters And Receivers, Physiological Signal, Radiofrequency
- ETFUnit, Examining/Treatment, Ent
- EIAUnit, Operative Dental
- NRDUnit, Operative Dental, Accessories
- EBRUnit, Suction Operatory
- EHDUnit, X-Ray, Extraoral With Timer
- OASX-Ray, Tomography, Computed, Dental
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-3013-2026 | Midmark Digital ECG HD+12, HD+15, Model/Catalog Number: 4-000-0080 Software Version: Midmark IQecg Plugin versions starting with v10 and prior to v10.1.0.18. | A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation. | Class II | Open, Classified | |
| Z-3012-2026 | Midmark IQecg Digital ECG, Model/Catalog Number: 4-000-0061, 4-000-0062 Software Version: Midmark IQecg Plugin versions starting with v10 and prior to v10.1.0.18. | A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation. | Class II | Open, Classified | |
| Z-0597-2012 | Midmark M11 Ultra Steam Sterilizer, Distributed by: Midmark Corporation, 60 Vista Drive, Versailles, Ohio 45380. Sterilize reusable equipment that is heat and moisture stable. | During and FDA inspection on 8/23/2011, it was discovered that the firm received numerous reports of the steam sterilizer malfunctioning. | Terminated | ||
| Z-0704-03 | Midmark M7 UltraClave and Ritter M7 SpeedClave, Tabletop Steam Sterilizers. | The pressure relief valve may fail to open properly. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain