Ad-Tech Medical Instrument Corporation

FDA Regulatory Profile

Summary

Total Recalls
17 (1 Class I)
510(k) Clearances
8
Inspections
8
Compliance Actions
2

Recent Recalls

NumberClassProductDate
Z-0219-2025Class IIAD-TECH Spencer Probe Depth Electrode, REF SD04R-AP58X-000 4-Contact 1.12mm (A style) Depth ElectrodSeptember 19, 2024
Z-0221-2025Class IIAD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Depth ElectrodSeptember 19, 2024
Z-0220-2025Class IIAD-TECH Spencer Probe Depth Electrode, REF SD06R-AP58X-000 6-Contact 1.12mm (A style) Depth ElectrodSeptember 19, 2024
Z-2494-2021Class IIAd-Tech Lightweight CABRIO Cable - Product Usage: Designed for the purpose of connecting these electAugust 9, 2021
Z-2496-2021Class IIAd-Tech TECH ATTACH Cable- Product Usage: Designed for the purpose of connecting these electrodes toAugust 9, 2021
Z-2495-2021Class IIAd-Tech Lightweight TECH ATTACH Cable - Product Usage: Designed for the purpose of connecting these August 9, 2021
Z-2544-2019Class IIAD-TECH Drill Sleeve Guides, used with Ad-Tech Placement Kits: (a) REF DSG-90-2.3N (b) REF DSG-6.3August 27, 2019
Z-2406-2019Class IIDual-Sided Interhemispheric, Grid, Intraoperative, Strip, Wyler Subdural ElectrodesJune 18, 2019
Z-2204-2019Class IILSB Style Anchor Bolt. Labeled with the following parts: 13mm anodized anchor bolt body with aJune 18, 2019
Z-2408-2019Class IISkull Anchor BoltsJune 18, 2019
Z-2407-2019Class IIDepth Electrodes, Foramen Ovale Depth Electrodes, Macro Micro Depth Electrodes, Spencer Probe Depth June 18, 2019
Z-2396-2019Class IIAD-TECH Spencer Probe Depth Electrode Product Usage: The Ad-Tech Depth Electrodes (Depth ElectroApril 16, 2019
Z-2539-2018Class IIAD-TECH Medical Instrument Corporation Drill Sleeve Guides DSG-6-3-090-2.4N utilizing raw material (May 2, 2018
Z-1938-2018Class IIDisposable Drill Kit which includes two drill bits, two drill stops, and two adjustment wrenches, stDecember 20, 2017
Z-1503-2016Class IIAd-Tech Electrode Connection System/Cables. Lightweight TECH-ATTACH Cable Models: 1. L-DCL-4DINMarch 29, 2016
Z-0106-2015Class IIBox Label: 3 mm Cueva Electrode Kit, Sterile EO, Rx Only, REF. CNE1-3KDINX . Pouch labels: Each kitOctober 8, 2014
Z-0892-2013Class IAd-Tech Medical Instrument Corporation Macro Micro Subdural Electrode. For temporary (<30 days) useDecember 18, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K223269Spencer Probe Depth ElectrodesMay 18, 2023
K223276Anchor Bolts as Accessories to Depth ElectrodesMay 18, 2023
K191186Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid Electrode, Dual-SidJanuary 25, 2020
K181544Anchor Bolt (as an accessory to Depth Electrodes)August 9, 2018
K170442Cranial Drill Bits and AccessoriesSeptember 7, 2017
K163355Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth EApril 12, 2017
K152769FREMAP ELECTRODEMay 6, 2016
K152547DNAP ElectrodeMarch 4, 2016