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Ad-Tech Medical Instrument Corp.

United States·US-MF-000004795

Last updated September 17, 2026

About

Ad-Tech's electrode devices are used for EEG monitoring and brain mapping for epilepsy and brain diseases.

From the manufacturer's own website. Source

What Ad-Tech Medical Instrument Corp. makes

Ad-Tech Medical Instrument Corp. makes cortical electrodes, depth electrodes, subdermal needle electrodes, neurological stereotactic surgery systems, brain biopsy procedure kits, fluted surgical drill bits (single-use), wire/ligature passers (reusable), and single-use scalpels.

These devices are classified as Class I and Class II medical devices and are listed in the FDA UDI registry; the company is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Ad-Tech Medical Instrument Corp. manufacture?

Ad-Tech Medical Instrument Corp. manufactures cortical electrodes, depth electrodes, subdermal needle electrodes, neurological stereotactic surgery systems, brain biopsy procedure kits, fluted surgical drill bits (single-use), wire/ligature passers (reusable), and single-use scalpels. These products are designed for neurological applications such as EEG monitoring and brain mapping, particularly in epilepsy and brain disease diagnostics. The company’s device portfolio focuses on tools used in surgical and diagnostic procedures involving the brain and nervous system.

Where is Ad-Tech Medical Instrument Corp. based?

Ad-Tech Medical Instrument Corp. is based in the United States. This information is explicitly provided in the device data under the COUNTRY field, which specifies US as the company’s location. The summary also confirms the company’s U.S. base, which is relevant for understanding its regulatory jurisdiction and market operations.

In which regulatory registry are Ad-Tech Medical Instrument Corp.'s devices listed?

Ad-Tech Medical Instrument Corp.'s devices are listed in the FDA UDI registry. This is indicated in the LISTED IN field of the device data, which specifies fda_udi as the registry. The FDA UDI (Unique Device Identification) system is used to track medical devices in the United States, and inclusion in this registry means the company’s devices have been assigned UDIs for traceability, though this does not imply device approval or clearance.

How are Ad-Tech Medical Instrument Corp.'s devices classified under regulatory frameworks?

Ad-Tech Medical Instrument Corp.'s devices are classified as Class I and Class II medical devices. This classification is stated directly in the DEVICE CLASSES field of the provided data. Class I devices are subject to general controls, while Class II devices require special controls in addition to general controls, reflecting moderate to low risk. The classification applies to the device types manufactured, such as electrodes and surgical tools, and is determined by their intended use and risk profile.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: United States
Address: 400 West Oakview Parkway, Oak Creek, United States
Website: adtechmedical.com/
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 262 634 1555
PRRC Contact: Frederick Guesneau
EUDAMED SRN: US-MF-000004795
FDA FEI Number: 2183456
DUNS Number: —

Catalogue (988)

Page 2 of 20

Device	Model / Reference	Registries	Class	Status
Subdural Electrode	FGC0C-SP08X-0T6	FDA UDI	Class II	Active
Subdural Electrode	FG32D-SS10X-0CB	FDA UDI	Class II	Active
Subdural Electrode	TS06R-SP10X-0P1	FDA UDI	Class II	Active
Spencer Probe Depth Electrode	SD08R-SP10X-AN1	FDA UDI	Class II	Active
Spencer Probe Depth Electrode	RD08R-SP04X-000	FDA UDI	Class II	Active
Subdural Electrode	IS04R-SP10X-0T7	FDA UDI	Class II	Active
Subdural Electrode	FG32A-SP05X-0H6	FDA UDI	Class II	Active
Anchor Bolt Kit, LSB Style	LSBK1-CX-05	FDA UDI	Class II	Active
Subdural Electrode	TS01R-SP00X-0W6	FDA UDI	Class II	Active
Subdural Electrode	FG32E-SP10X-0D1	FDA UDI	Class II	Active
Subdural Electrode	IGZ8A-MP04X-0JC	FDA UDI	Class II	Active
Spencer Probe Depth Electrode	SD04R-SP05X-000	FDA UDI	Class II	Active
Macro Depth Electrode	2	FDA UDI	Class II	Active
Spencer Probe Depth Electrode	SD046-SP07X-A00	FDA UDI	Class II	Active
Sphenoidal Electrode Set	711-APX-01	FDA UDI	Class II	Active
Subdural Electrode	FG12A-SS10X-000	FDA UDI	Class II	Active
Spencer Probe Depth Electrode	RD06R-SP05X-000	FDA UDI	Class II	Active
Anchor Bolt Kit, LSB Style	LSBK1-AX-06	FDA UDI	Class II	Active
Subdural Electrode	TS06R-AP10X-0WL	FDA UDI	Class II	Active
Subdural Electrode	FG24G-SP10X-0C6	FDA UDI	Class II	Active
Subdural Electrode	TS10R-SS10X-000	FDA UDI	Class II	Active
Subdural Electrode	FG25B-SP10X-000	FDA UDI	Class II	Active
Subdural Electrode	FG16B-SP10X-000	FDA UDI	Class II	Active
Placement Wrench for LSB Bolts	LSB-PWL-2.4-10N	FDA UDI	Class I	Active
Subdural Electrode	TS16R-SP10X-000	FDA UDI	Class II	Active
Spencer Probe Depth Electrode	RD10R-SP05X-000	FDA UDI	Class II	Active
Subdural Electrode	FG12A-SP10X-0N2	FDA UDI	Class II	Active
Subdural Electrode	FG32C-SP10X-000	FDA UDI	Class II	Active
Spencer Probe Depth Electrode	LD10R-SP45X-000	FDA UDI	Class II	Active
Subdural Electrode	FG96N-SP05X-0JE	FDA UDI	Class II	Active
Subdural Electrode	PS04R-IP10X-000	FDA UDI	Class II	Active
Sphenoidal Electrode Set	711-1DINX-05	FDA UDI	Class II	Active
Subdural Electrode	FG36J-SP10X-000	FDA UDI	Class II	Active
Subdural Electrode	FG24G-SP05X-0E2	FDA UDI	Class II	Active
Subdural Electrode	FG64C-SP10X-043	FDA UDI	Class II	Active
Macro Depth Electrode	BF09R-SP44X-0BB	FDA UDI	Class II	Active
Subdural Electrode	FG12A-SP10X-000	FDA UDI	Class II	Active
Subdural Electrode	FG16A-SP10X-C00	FDA UDI	Class II	Active
Leksell Guide Block Set	LK-GB-N-13	FDA UDI	Class II	Active
Subdural Electrode	FG22A-SP10X-0N2	FDA UDI	Class II	Active
Subdural Electrode	GG48D-SP10X-400	FDA UDI	Class II	Active
Subdural Electrode	IS08I-SP10X-BC9	FDA UDI	Class II	Active
Sphenoidal Electrode Set	711-1PDINX-33	FDA UDI	Class II	Active
Sphenoidal Electrode Set	711-AX-38	FDA UDI	Class II	Active
Subdural Electrode	IG32C-SP10X-0TB	FDA UDI	Class II	Active
Two-Piece Slotted Cannula	2SC-190N	FDA UDI	Class I	Active
Subdural Electrode	ZS08R-GP10X-WW6	FDA UDI	Class II	Active
Subdural Electrode	IS05R-SP10X-000	FDA UDI	Class II	Active
Subdural Electrode	FG64C-SP10X-000	FDA UDI	Class II	Active
Lightweight CABRIO Cable	L-SRL-8DIN-30	FDA UDI	Class II	Unknown

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FDA Recalls (17)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

The FDA recall records for Ad-Tech Medical Instrument Corp. consist of 17 records, with the earliest initiated on 2012-12-18 and the most recent on 2024-09-19. The recorded statuses of these recalls include open, classified, and terminated. The reasons given for the recalls include issues such as label discrepancies, device malfunctions, packaging failures, and incorrect supplemental information. The specific reasons provided in the records include problems with electrode labels, device testing issues, sterile barrier compromises, and concerns about device performance in certain environments.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Sep 19, 2024	Z-0221-2025	—	open, classified	Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified on A style contact SD electrodes where the MR Conditional symbol was incorrectly placed instead of the MR Unsafe symbol. The A style contacts were not cleared for MR Conditional use. Our records indicate you have received one or more of the affected lots listed above.
Sep 19, 2024	Z-0220-2025	—	open, classified	Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified on A style contact SD electrodes where the MR Conditional symbol was incorrectly placed instead of the MR Unsafe symbol. The A style contacts were not cleared for MR Conditional use. Our records indicate you have received one or more of the affected lots listed above.
Sep 19, 2024	Z-0219-2025	—	open, classified	Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified on A style contact SD electrodes where the MR Conditional symbol was incorrectly placed instead of the MR Unsafe symbol. The A style contacts were not cleared for MR Conditional use. Our records indicate you have received one or more of the affected lots listed above.
Aug 9, 2021	Z-2494-2021	—	terminated	Incorrect version of labels were used.
Aug 9, 2021	Z-2495-2021	—	terminated	Incorrect version of labels were used.
Aug 9, 2021	Z-2496-2021	—	terminated	Incorrect version of labels were used.
Aug 27, 2019	Z-2544-2019	—	terminated	The inner diameter of the drill sleeve guide raw material was found to be under tolerance, potentially resulting in the drill bit seizing in the guide during surgery.
Jun 18, 2019	Z-2407-2019	—	terminated	Supplemental information provided with devices indicates that the subdural electrodes, depth electrodes, and anchor bolts are approved for use in the MR environment, for which they are not approved for such use.
Jun 18, 2019	Z-2408-2019	—	terminated	Supplemental information provided with devices may indicate that the subdural electrodes, depth electrodes, and anchor bolts are approved for use in the MR environment, for which they are not approved for such use.
Jun 18, 2019	Z-2406-2019	—	terminated	Supplemental information provided with devices indicates that the subdural electrodes, depth electrodes, and anchor bolts are approved for use in the MR environment, for which they are not approved for such use.
Jun 18, 2019	Z-2204-2019	—	terminated	On June 12, 2019 Ad-Tech was made aware that on three different occasions between March 1, 2019 and May 31, 2019 Ad-Tech personnel have distributed non-sterile anchor bolt parts to one independent representative and one international distributor, who may have subsequently sterilized the non-sterile anchor bolts for clinical use. Ad-Tech does not have regulatory clearance to distribute non-sterile anchor bolts and does not have a validated hospital sterilization method for these devices. Further, Ad-Tech labeling does not include instructions for sterilizing anchor bolts.
Apr 16, 2019	Z-2396-2019	—	terminated	An Ad-Tech Clinical Specialist, attended a case on April 15, 2019. During the case the surgeon encountered an issue after implanting four Ad-Tech depth electrodes. Upon initial device testing subsequent to implantation it was identified that two of the devices that were labeled as 8 contact depth electrodes (SD08R-SP05X-000) were in fact 6 contact depth electrodes (SD06R-SP05X-000) . There was no impact to the patient due to this incident.
May 2, 2018	Z-2539-2018	—	terminated	The diameter of the drill sleeve guide raw material was found to be under tolerance, potentially resulting in the drill bit seizing in the guide during surgery.
Dec 20, 2017	Z-1938-2018	—	terminated	There is a possibility that DDK2-2.4-30X Disposable Drill Kits, Lot Number 111664 208140649 contained 2.8mm drill bits from DDK2-2.8-30X Disposable Drill Kits, Lot Number 111745 208140649 and vice versa.
Mar 29, 2016	Z-1503-2016	—	terminated	Ad-Tech is recalling unopened/unused sterile cables intended to be used only with all compatible Ad-Tech electrodes for the purpose of connecting these electrodes to third party monitors/stimulators. This recall has been initiated due to package failures (i.e. compromised sterile barriers) that were identified during the execution of a shipping simulation investigation.
Oct 8, 2014	Z-0106-2015	—	terminated	The recall has been initiated due to concerns that the applicator wand may malfunction potentially causing the inability to monitor the VII cranial nerve. .
Dec 18, 2012	Z-0892-2013	—	terminated	The microelectrodes are not flush with the silastic substrate, may contain sharp edges capable of abrading the cortical surface, and may have remaining pieces which may fracture and remain in the cortical tissue with the electrode is explanted. Recall expanded on 5/2/2013 to include additional Macro Micro Subdural Electrodes.