Imex Medical Systems, Inc.

Mchenry, IL, US

Imex Medical Systems, Inc. appears in FDA device records in Mchenry, IL. FDA records list 19 510(k) clearances between 1983-09-20 and 1998-04-24, no PMA records and no registered establishments. As of 2026-09-10, FDA records show no recalls for this company.

510(k) clearances: 19
PMA records: 0
Recall records: 0
Registered establishments: 0

510(k) clearance history

FDA records hold 19 510(k) clearances for Imex Medical Systems, Inc. between 1983 and 1998. The busiest year on record is 1984, with 3. The most recent is 1998, with 3.

Clearances by year, as a table

510(k) clearance decisions for Imex Medical Systems, Inc., by decision year
Year	Clearances
1983	1
1984	3
1985	1
1987	2
1988	2
1990	2
1991	1
1994	1
1995	2
1997	1
1998	3

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K973556	IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9000	IYN	Substantially Equivalent	1998-04-24
K973562	IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9100	IYN	Substantially Equivalent	1998-04-15
K973336	IMEX STETHODOP	JAF	Substantially Equivalent	1998-02-05
K970156	IMEX FUTURALDOP PRO	IYO	Substantially Equivalent	1997-04-04
K942243	IMEX 8000 PERSONAL CASCULAR LAB	IYO	Substantially Equivalent	1995-11-03
K944196	IMWXDOP IR	JAF	Substantially Equivalent	1995-05-12
K942441	IMEXDOP CT+	JAF	Substantially Equivalent	1994-08-23
K910462	POCKET DOP 3	HEP	Substantially Equivalent	1991-06-24
K901593	IMEX DOP-TONE II	KNG	Substantially Equivalent	1990-07-02
K896613	FLAT VASCULAR PROBE	DPW	Substantially Equivalent	1990-02-16
K882138	IMEXLAB 3000 VASCULAR DIAGNOSTIC RECORDER	DPW	Substantially Equivalent	1988-11-07
K874726	MASCOT STETHOSCOPE PROBE	DQD	Substantially Equivalent	1988-03-31
K871212	MASCOT CW DOPPLER SYSTEM	JOP	Substantially Equivalent	1987-08-14
K863702	PULSE CUFF RECORDER MODEL PCR100	JOM	Substantially Equivalent	1987-06-12
K851269	DOPLETTE 10	JOP	Substantially Equivalent	1985-07-29
K840285	NON STRESS TEST MONITOR 507	HGH	Substantially Equivalent	1984-05-09
K834284	ULTRASOUND SCANNER 501	IYO	Substantially Equivalent	1984-05-09
K832369	VASCULAR RECORDER #301	JOP	Substantially Equivalent	1984-03-12
K832696	RISER STANDUP WHEELCHAIR	IPL	Substantially Equivalent	1983-09-20

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets Imex Medical Systems, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Imex Medical Systems, Inc.. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.

Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain