Ohio Medical Instrument Co., Inc.

Wrentham, MA, US

Ohio Medical Instrument Co., Inc. appears in FDA device records in Wrentham, MA. FDA records list 19 510(k) clearances between 1983-03-02 and 2002-07-29, no PMA records and no registered establishments. As of 2026-09-10, FDA records show 3 recalls for this company.

510(k) clearances: 19
PMA records: 0
Recall records: 3
Registered establishments: 0

FDA records under these names

1 name

FDA records resolved to Ohio Medical Instrument Co., Inc. 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.

Schaerer Medical USA Incenforcement report, recall

510(k) clearance history

FDA records hold 19 510(k) clearances for Ohio Medical Instrument Co., Inc. between 1983 and 2002. The busiest year on record is 1993, with 3. The most recent is 2002, with 2.

Clearances by year, as a table

510(k) clearance decisions for Ohio Medical Instrument Co., Inc., by decision year
Year	Clearances
1983	2
1985	2
1989	1
1990	1
1993	3
1994	1
1995	1
1996	2
1998	2
1999	2
2002	2

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K021604	MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020	HBL	Substantially Equivalent	2002-07-29
K013428	MAYFIELD/ACCISS OPERATING ARM SYSTEM AND MAYFIELD/OPTICAL ACCISS SYSTEM	HAW	Substantially Equivalent	2002-04-04
K992843	THE MAYFIELD / ACCISS SYSTEM WITH WINDOWS NT FOR CRANIAL SURGERY, THE MAYFIELD / OPTICAL ACCISS SYSTEM WITH WINDOWS NT F	HAW	Substantially Equivalent	1999-11-02
K991267	SPINE APPLICATIONS FOR THE MAYFIELD/ACCISS OPERATING ARM AND OPTICAL ACCISS SYSTEMS MODULE, MAYFIELD/ACCISS SPINE RING A	HAW	Substantially Equivalent	1999-07-12
K983282	OMI OCCIPITAL CERVICAL LOOP, MODEL A1089	KWP	Substantially Equivalent	1998-11-19
K982244	MAYFIELD ACCISS OPTICAL SYSTEM	HAW	Substantially Equivalent	1998-09-23
K960807	TEW CRANIAL/SPINAL RETRACTOR MODEL A1090	GZT	Substantially Equivalent	1996-05-17
K953124	MAYFIELD RADIOLUCENT 2000 SKULL CLAMP	HBL	Substantially Equivalent	1996-02-09
K941558	MAYFIELD CHILD DISPOSABLE SKULL PIN	HBL	Substantially Equivalent	1995-12-06
K934289	MAYFIELD RADIOLUCENT SKULL CLAMP	HBL	Substantially Equivalent	1994-01-07
K932860	MAYFIELD ADULT DISPOSABLE SKULL PIN	HBL	Substantially Equivalent	1993-09-28
K932807	MAYFIELD* A-2000 SKULL CLAMP	HBL	Substantially Equivalent	1993-09-28
K923789	MAYFIELD ADULT DISPOSABLE SKULL PIN	HBL	Substantially Equivalent	1993-02-12
K902077	T19S BIOPSY NEEDLE	KNW	Substantially Equivalent	1990-07-27
K882544	CUDDLE UP PILLOW	FRP	Substantially Equivalent	1989-01-31
K851021	MAYFIELD TABLE-ELECTRIC	GDC	Substantially Equivalent	1985-05-21
K851022	SINGLE LEG MAYFIELD TABLE		Substantially Equivalent	1985-04-17
K837028	PARKINSON NEUROSURGICAL HEADCLAMP FOR SERIAL ANGIOGRAPHY		Substantially Equivalent	1983-03-09
K830332	BUDDE-HALO RETRACTOR	GZT	Substantially Equivalent	1983-03-02

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-0372-2017	Replacement floor locking cylinders for the Schaerer model 7300 surgical tables. Replacement cylinders are part number 85118. Product Usage: The cylinders are used to lock the surgical table in place.	The floor locking cylinders are contained in the base of the Schaerer 7300 model surgical tables. The cylinders were manufactured with the incorrect "O" ring which may cause the cylinder to leak.	Class II	2016-09-27	Terminated
Z-0371-2017	The surgical table is a stand alone unit. Three (3) floor locking cylinders are attached to the base of the surgical table. The individual cylinders are replaceable. Product Usage: The cylinders are used to lock the surgical table in place.	The floor locking cylinders contained in the base of the Schaerer 7300 model surgical tables were manufactured with the incorrect "O" ring which may cause the cylinder to leak.	Class II	2016-09-27	Terminated
Z-0781-03	Halo Support Bracket Assembly (Part #438-B1010). The bracket is sold as a component of the BUDDE Halo Neurosurgical Retractor System, or sold as a separate component. The defective sub-assembly part is the Clamp Assembly (Part #438A1071), which is part of the Halo Bracket Assembly.	The component was manufactured with an insufficient weld that could break during use.		2003-02-26	Terminated

Verification record

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