Data / Medical devices / United States / Midmark Corporation

Midmark Corporation: FDA-registered device maker in Versailles, OH, United States, 10 510(k) clearances

Name: Midmark Corporation FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Midmark Corporation is registered with the FDA (registration 1523530) in Versailles, OH, United States. It lists 20 device types. The FDA files 10 510(k) clearances under its listings, the newest dated November 3, 2025. 4 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Midmark Corporation

FDA registration number: 1523530
Address: 60 Vista Dr, Versailles, OH, United States, 45380
Owner or operator: MIDMARK CORP. (9915004)
Roles: Manufacturer, Repackager or relabeler, Specification developer
First device listed: July 15, 1987
Registered through: 2026
Brand names listed: ClassicSeries, Elevance, IQvitals, IQvitals PC, MIDMARK, Midmark, Midmark Cuspidor, Midmark Dental Delivery System and more

Devices it lists

Device	Product code	Class	Role	Source
Board, Arm (With Cover), Non-Sterile	NOD	1	Manufacturer	accessdata.fda.gov
Chair, Blood Donor	FML	1	Specification developer	accessdata.fda.gov
Chair, Dental, Without Operative Unit	NRU	1	Manufacturer	accessdata.fda.gov
Chair, Examination And Treatment	FRK	1	Manufacturer, Specification developer	accessdata.fda.gov
Chair, Surgical, Ac-Powered	GBB	1	Manufacturer	accessdata.fda.gov
Device, Medical Examination, Ac Powered	KZF	1	Manufacturer	accessdata.fda.gov
Electrocardiograph	DPS	2	Manufacturer	accessdata.fda.gov
Light, Operating, Dental	EAZ	1	Manufacturer	accessdata.fda.gov
Medical Device Data System	OUG	1	Manufacturer	accessdata.fda.gov
Restraint, Protective	FMQ	1	Manufacturer	accessdata.fda.gov
Scale, Patient	FRW	1	Manufacturer	accessdata.fda.gov
Stand, Infusion	FOX	1	Manufacturer	accessdata.fda.gov
Sterilizer, Steam	FLE	2	Manufacturer	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	Repackager or relabeler	accessdata.fda.gov
System, X-Ray, Extraoral Source, Digital	MUH	2	Manufacturer	accessdata.fda.gov
Transmitters And Receivers, Physiological Signal, Radiofrequency	DRG	2	Repackager or relabeler	accessdata.fda.gov
Unit, Operative Dental	EIA	1	Manufacturer	accessdata.fda.gov
Unit, Operative Dental, Accessories	NRD	1	Manufacturer	accessdata.fda.gov
Unit, Suction Operatory	EBR	1	Manufacturer	accessdata.fda.gov
Unit, X-Ray, Extraoral With Timer	EHD	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
November 3, 2025	K251626	Midmark Dental Delivery System	EIA	Substantially Equivalent	Midmark Corporation	accessdata.fda.gov
April 4, 2024	K233026	Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer	FLE	Substantially Equivalent	Midmark Corporation	accessdata.fda.gov
May 15, 2023	K220526	HD+12, HD+15	DRG	Substantially Equivalent	Cardioline S.P.A	accessdata.fda.gov
August 31, 2017	K163337	Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer	FLE	Substantially Equivalent	Midmark Corporation	accessdata.fda.gov
November 22, 2011	K112380	CLEARVISION	MUH	Substantially Equivalent	Midmark Corp.	accessdata.fda.gov
March 22, 2011	K103640	MIDMARK IQECG	DPS	Substantially Equivalent	Brentwood Medical Technology Corp.	accessdata.fda.gov
May 26, 2010	K100913	IQVITALS AND IQVITALS SYSTEM	DXN	Substantially Equivalent	Brentwood Medical Technology Corp.	accessdata.fda.gov
April 26, 2007	K070664	PROGENY IMAGING SOFTWARE, MODEL# 500-405 (6,7,8).	MUH	Substantially Equivalent	Progeny, Inc.	accessdata.fda.gov
December 13, 2004	K043092	PREVA, 76IN ARM, 66IN ARM, 56IN ARM, MODELS P7017, P7016, P7015	EHD	Substantially Equivalent	Progeny, Inc.	accessdata.fda.gov
October 18, 2000	K003090	MIDMARK PROCENTER INSTRUMENT DELIVERY SYSTEM	EIA	Substantially Equivalent	Midmark Corp.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
August 21, 2026	99641	Class II	Ongoing	Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult and pediatric patients, Model Number: with	A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.	accessdata.fda.gov
July 20, 2026	99404	Class II	Ongoing	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.	accessdata.fda.gov
October 24, 2011	60456	Not yet classified	Terminated	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.	accessdata.fda.gov
March 5, 2003	25727	Not yet classified	Terminated	Midmark M7 UltraClave and Ritter M7 SpeedClave, Tabletop Steam Sterilizers.	The pressure relief valve may fail to open properly.	accessdata.fda.gov

Compare with other makers

Updated September 18, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. 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.