Ad-Tech Medical Instrument Corporation
Ad-Tech Medical Instrument Corporation holds FDA 510(k) medical device clearances, first cleared 2016, most recent 2023, with 17 FDA device recalls on record.
Top product codes for Ad-Tech Medical Instrument Corporation
FDA recalls by Ad-Tech Medical Instrument Corporation
10 most recent of 17- Z-0219-2025 — AD-TECH Spencer Probe Depth Electrode, REF SD04R-AP58X-000 4-Contact 1.12mm (A style) Depth Electrode
- Z-0220-2025 — AD-TECH Spencer Probe Depth Electrode, REF SD06R-AP58X-000 6-Contact 1.12mm (A style) Depth Electrode
- Z-0221-2025 — AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Depth Electrode
- Z-2495-2021 — Ad-Tech Lightweight TECH ATTACH Cable - Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/stimulators.
- Z-2494-2021 — Ad-Tech Lightweight CABRIO Cable - Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/stimulators.
- Z-2496-2021 — Ad-Tech TECH ATTACH Cable- Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/stimulators.
- Z-2544-2019 — AD-TECH Drill Sleeve Guides, used with Ad-Tech Placement Kits: (a) REF DSG-90-2.3N (b) REF DSG-6.3-090-2.4N
- Z-2204-2019 — LSB Style Anchor Bolt. Labeled with the following parts: 13mm anodized anchor bolt body with anchor bolt cap containing a blue gasket and silicone cap, 21mm anodized anchor bolt body with anchor bolt cap containing a blue gasket and silicone cap, 13mm non-anodized anchor bolt body with anchor bolt cap containing a green gasket and silicone cap, 26mm non-anodized anchor bolt body with anchor bolt cap containing a blue gasket and silicone cap - Product Usage: The Ad-Tech Anchor Bolts are optional accessories for use with Depth Electrodes. The Anchor Bolts may be applied when it is desired to minimize concerns about potential cerebrospinal fluid (CSF) leakage and infection of the subdural space while stabilizing the electrode. Anchor Bolts are secured in the skull to provide an access point for Depth Electrodes.
- Z-2406-2019 — Dual-Sided Interhemispheric, Grid, Intraoperative, Strip, Wyler Subdural Electrodes
- Z-2408-2019 — Skull Anchor Bolts
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Ad-Tech Medical Instrument Corporation
- K223269 — Spencer Probe Depth Electrodes
- K223276 — Anchor Bolts as Accessories to Depth Electrodes
- K191186 — Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid Electrode, Dual-Sided Interhemispheric Subdural Electrode, Multi-Strip and Slit Grid Subdural Electrode, Intraoperative Mapping Grid Subdural Electrode
- K181544 — Anchor Bolt (as an accessory to Depth Electrodes)
- K170442 — Cranial Drill Bits and Accessories
- K163355 — Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes
- K152769 — FREMAP ELECTRODE
- K152547 — DNAP Electrode
Data sourced from openFDA. This site is unofficial and independent of the FDA.