BETA
Manufacturer of medical examination and procedure chairs, steam sterilizers and connected diagnostic devices.
Midmark Corporation designs and manufactures clinical equipment and related workflow solutions. Founded in 1915, the company is headquartered in Versailles, Ohio, with additional U.S. locations and international subsidiaries in India and Italy.
Its human medical portfolio includes powered examination and procedure chairs, steam sterilizers and digital diagnostic devices. This profile covers selected current medical product families; Midmark also operates dental and animal-health businesses.
Midmark combines branded device manufacturing with clinical-space design, connectivity and service offerings. Cabinetry, workstations and general seating are not automatically treated as medical devices. Regulatory evidence is matched to specific product generations rather than applied across the entire catalog.
Device records name MIDMARK CORPORATION as labeler of model 626-004, report commercial distribution and premarket exemption under product code GBB. The record describes support and positioning during examinations and optional weight measurement. Exemption and device listing are distinct from FDA clearance. [1]
The selected current portfolio includes K233026, cleared April 4, 2024 for Midmark Smart M9 and M11 sterilizers, and K253196, cleared June 12, 2026 for the Midmark 800 Digital Vital Signs Device. Both identify Midmark Corporation as applicant. These are two selected decisions, not a company-wide clearance inventory. [2][3]
The 631 is marketed for patient positioning during procedures, but its model-specific regulatory basis remains to be mapped. Accessibility standards and commercial availability do not independently establish FDA clearance. [21]
FDA reports an open August 2026 correction covering specified IQvitals Zone models for potentially inaccurate blood-pressure readings using the Linear Deflation Method (event 99641; four product records). The former IQvitals Zone product URL now redirects to the Midmark 800. This redirect does not establish that the 800 is included in that correction; consult the affected-model records and current manufacturer instructions. [10][12][14][16]
FDA also reports an open July 2026 ECG software correction (event 99404) covering specified IQecg and Digital ECG models and plugin versions for incorrect waveforms and pulse-rate calculations. The ECG products fall outside this profile’s selected commercial families; the correction is included as additional safety context. [6][8]
A 2011 recall of specified older M11 sterilizer models was terminated June 20, 2014. It is historical and is not attributed to the current Smart M11 generation. Applicant-name searches also returned older and dental records outside this selected medical portfolio. [4]
Latest recorded source review: 2026-10-28.
Includes open events outside the mapped current portfolio; those events are excluded from the snapshot count.
| Recalled product / record | Initiated | Source |
|---|---|---|
| August 21, 2026 | [10][11][12][13][14][15][16][17] |
| July 20, 2026 | [6][7][8][9] |
Documented commercial product families.
Height-adjustable chair for patient positioning and support during general examinations, with optional integrated digital scale and device connectivity. [22][1]
Exemption documentedListed by the company; configurations and market availability vary.
Chair with powered positioning, adjustable height and patient-support features for in-office medical procedures. [21]
Marketed · regulatory scope variesListed by the company; configurations and market availability vary.
Tabletop steam sterilizers for processing compatible reusable medical instruments, with touchscreen controls and automated cycle recordkeeping. The M11 is illustrated. [24][25][2]
FDA-clearedListed by the company; configurations and market availability vary.
Automated monitor for blood pressure, pulse, temperature and optional oxygen saturation, with configuration-dependent respiration measurement and EMR connectivity. [23][3]
FDA-clearedListed by the company; configurations and market availability vary.
Current product pages document ongoing commercialization of the 631 procedure chair, next-generation M9/M11 sterilizers and Midmark 800 diagnostic device. The 800 has a separate FDA clearance from legacy IQvitals Zone equipment. [21][24][25][23][3]
FDA issued K253196 for the Midmark 800 Digital Vital Signs Device. [3]
FDA issued K233026 for Midmark Smart M9 and Smart M11 sterilizers. [2]
Accessed 10/28/2026