Company ยท US
Ohio Medical Instrument Co., Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1983 to 2002. Name variants (Inc, Corp, punctuation) are merged.
19510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 29, 2002 | K021604 | MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020 Ohio Medical Instrument Co., Inc. | HBL |
| Apr 4, 2002 | K013428 | MAYFIELD/ACCISS OPERATING ARM SYSTEM AND MAYFIELD/OPTICAL ACCISS SYSTEM Ohio Medical Instrument Co., Inc. | HAW |
| Nov 2, 1999 | K992843 | THE MAYFIELD / ACCISS SYSTEM WITH WINDOWS NT FOR CRANIAL SURGERY, THE MAYFIELD / OPTICAL ACCISS SYSTEM WITH WINDOWS NT F Ohio Medical Instrument Co., Inc. | HAW |
| Jul 12, 1999 | K991267 | SPINE APPLICATIONS FOR THE MAYFIELD/ACCISS OPERATING ARM AND OPTICAL ACCISS SYSTEMS MODULE, MAYFIELD/ACCISS SPINE RING A Ohio Medical Instrument Co., Inc. | HAW |
| Nov 19, 1998 | K983282 | OMI OCCIPITAL CERVICAL LOOP, MODEL A1089 Ohio Medical Instrument Co., Inc. | KWP |
| Sep 23, 1998 | K982244 | MAYFIELD ACCISS OPTICAL SYSTEM Ohio Medical Instrument Co., Inc. | HAW |
| May 17, 1996 | K960807 | TEW CRANIAL/SPINAL RETRACTOR MODEL A1090 Ohio Medical Instrument Co., Inc. | GZT |
| Feb 9, 1996 | K953124 | MAYFIELD RADIOLUCENT 2000 SKULL CLAMP Ohio Medical Instrument Co., Inc. | HBL |
| Dec 6, 1995 | K941558 | MAYFIELD CHILD DISPOSABLE SKULL PIN Ohio Medical Instrument Co., Inc. | HBL |
| Jan 7, 1994 | K934289 | MAYFIELD RADIOLUCENT SKULL CLAMP Ohio Medical Instrument Co., Inc. | HBL |
| Sep 28, 1993 | K932860 | MAYFIELD ADULT DISPOSABLE SKULL PIN Ohio Medical Instrument Co., Inc. | HBL |
| Sep 28, 1993 | K932807 | MAYFIELD* A-2000 SKULL CLAMP Ohio Medical Instrument Co., Inc. | HBL |
| Feb 12, 1993 | K923789 | MAYFIELD ADULT DISPOSABLE SKULL PIN Ohio Medical Instrument Co., Inc. | HBL |
| Jul 27, 1990 | K902077 | T19S BIOPSY NEEDLE Ohio Medical Instrument Co., Inc. | KNW |
| Jan 31, 1989 | K882544 | CUDDLE UP PILLOW Ohio Medical Instrument Co., Inc. | FRP |
| May 21, 1985 | K851021 | MAYFIELD TABLE-ELECTRIC Ohio Medical Instrument Co., Inc. | GDC |
| Apr 17, 1985 | K851022 | SINGLE LEG MAYFIELD TABLE Ohio Medical Instrument Co., Inc. | |
| Mar 9, 1983 | K837028 | PARKINSON NEUROSURGICAL HEADCLAMP FOR SERIAL ANGIOGRAPHY Ohio Medical Instrument Co., Inc. | |
| Mar 2, 1983 | K830332 | BUDDE-HALO RETRACTOR Ohio Medical Instrument Co., Inc. | GZT |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 25, 2003 | Ohio Medical Instrument Co Inc 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 Terminated |
GZT | K830332 |