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Sign in to claim this brandAd-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/
- —
- —
- [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 4 of 20| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Spencer Probe Depth Electrode | SD042-SP07X-A00 | FDA UDI | Class II | Active |
| Subdural Electrode | TS08R-SS10X-000 | FDA UDI | Class II | Active |
| Disposable Brain Biopsy Needle Kit | DBN-10-24X | FDA UDI | Class II | Active |
| Spencer Probe Depth Electrode | SD12R-SP09X-000 | FDA UDI | Class II | Active |
| Macro Depth Electrode | 0 | FDA UDI | Class II | Active |
| Foramen Ovale Depth Electrode | FO05K-SP05X-000 | FDA UDI | Class II | Active |
| Subdural Electrode | FG10A-IP10X-000 | FDA UDI | Class II | Active |
| Subdural Electrode | FG24K-SP05X-0E2 | FDA UDI | Class II | Active |
| Subdural Electrode | FG64C-SP05X-0CG | FDA UDI | Class II | Active |
| Subdural Electrode | FG64C-SP10X-0T7 | FDA UDI | Class II | Active |
| Subdural Electrode | FG20C-SP10X-0T7 | FDA UDI | Class II | Active |
| Subdural Electrode | FG40J-SP10X-040 | FDA UDI | Class II | Active |
| Obturator | OB-17-240X | FDA UDI | Class I | Active |
| Depth Electrode | RD16R-SP05X-000 | FDA UDI | Class II | Active |
| Subdural Electrode | TS06R-AP10X-0W6 | FDA UDI | Class II | Active |
| Macro-Micro Depth Electrode | MM16C-SP05X-000 | FDA UDI | Class II | Active |
| Spencer Probe Depth Electrode | SD06R-SP08X-000 | FDA UDI | Class II | Active |
| Subdural Electrode | TS12R-SP10X-000 | FDA UDI | Class II | Active |
| Subdural Electrode | FG20A-SP10X-000 | FDA UDI | Class II | Active |
| Subdural Electrode | IS04R-SS10X-0T1 | FDA UDI | Class II | Active |
| Disposable Drill Kit | DDK2-2.8-30X | FDA UDI | Class II | Active |
| Subdural Electrode | IS06R-SS10X-0HA | FDA UDI | Class II | Active |
| Subdural Electrode | FG64C-SS10X-006 | FDA UDI | Class II | Active |
| Sphenoidal Electrode Set | 711-1PDINX-01 | FDA UDI | Class II | Active |
| Subdural Electrode | FG10A-SS10X-000 | FDA UDI | Class II | Active |
| Subdural Electrode | MS08R-LP10X-000 | FDA UDI | Class II | Active |
| Subdural Electrode | FG32D-SP10X-0D1 | FDA UDI | Class II | Active |
| Subdural Electrode | FG99E-SP11X-0CB | FDA UDI | Class II | Active |
| Subdural Electrode | FG23B-SP10X-Z00 | FDA UDI | Class II | Active |
| Macro Depth Electrode | BF08R-SP51X-0C2 | FDA UDI | Class II | Active |
| Subdural Electrode | TS04R-SP05X-000 | FDA UDI | Class II | Active |
| Subdural Electrode | FG35C-SP10X-000 | FDA UDI | Class II | Active |
| Subdural Electrode | FG16D-IP10X-000 | FDA UDI | Class II | Active |
| Subdural Electrode | DG24A-SP10X-G00 | FDA UDI | Class II | Active |
| Subdural Electrode | FG08A-SP10X-0N2 | FDA UDI | Class II | Active |
| Spencer Probe Depth Electrode | SD05R-SP10X-0T0 | FDA UDI | Class II | Active |
| Sphenoidal Electrode Set | 711-1APX-01 | FDA UDI | Class II | Active |
| Macro-Micro Depth Electrode | MM16F-SP05X-0B9 | FDA UDI | Class II | Active |
| Disposable Brain Biopsy Needle Kit | DBN-08-24X | FDA UDI | Class II | Active |
| Subdural Electrode | PS04R-IP10X-0H1 | FDA UDI | Class II | Active |
| Spencer Probe Depth Electrode | SD14R-SP45X-0T1 | FDA UDI | Class II | Active |
| Subdural Electrode | TS08R-SP10X-000 | FDA UDI | Class II | Active |
| Subdural Electrode | MS06I-SP10X-Q00 | FDA UDI | Class II | Active |
| Spencer Probe Depth Electrode | SD06R-SP10X-000 | FDA UDI | Class II | Active |
| Two-Piece Slotted Cannula | 2SC-240N | FDA UDI | Class I | Active |
| Spencer Probe Depth Electrode | RD10R-SP07X-000 | FDA UDI | Class II | Active |
| Subdural Electrode | VG04A-IS00X-0KH | FDA UDI | Class II | Active |
| Subdural Electrode | IG48G-SP10X-0TB | FDA UDI | Class II | Active |
| Subdural Electrode | FG48G-SP10X-005 | FDA UDI | Class II | Active |
| Macro Depth Electrode | BF09R-SP03X-0BB | FDA UDI | Class II | Active |
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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. |