BEUDAMED
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    AD-TECH Medical Instrument Corporation Drill Sleeve Guides DSG-6-3-090-2.4N utilizing raw material (RM0677) from the following lots from vendor 00-0001062., AD0021502, AD0021628. Product Usage: The drill sleeve guides are accessories to the Ad-Tech Cranial Drill Bits. The Cranial Drill Bits and accessories are intended to be used for drilling holes in the skull for neurological procedures, such as brain biopsy, brain contacting electrode and electrode accessory device placement. The DSG-6.3-090-2.4N drill sleeve guides are intended to be used with the 2.4mm Cranial Drill Bit diameter.

    FDA Enforcement
    Class II ·Terminated·Ad-Tech Medical Instrument Corporation·August 1, 2018

    Ad-Tech Medical Instrument Corporation Macro Micro Subdural Electrode. For temporary (<30 days) use with recording, monitoring and stimulation equipment, for the recording, monitoring and stimulation of electrical signals on the surface level of the brain. The recording of electrical activity supports definition of the location of epileptogenic foci and brain mapping.

    FDA Enforcement
    Class I ·Terminated·Ad-Tech Medical Instrument Corporation·March 13, 2013

    Box Label: 3 mm Cueva Electrode Kit, Sterile EO, Rx Only, REF. CNE1-3KDINX . Pouch labels: Each kit contains 3 pouches. 3 mm Cueva Electrode CNE-3X, Cueva Electrode Applicator Wand CNE-100X, Cueva Electrode Leadwire CNE-LW-2DINX. Box Label: 2 mm Cueva Electrode Kit, Sterile EO, Rx Only, REF. CNE1-2KDINX . Pouch labels: Each kit contains 3 pouches. 3 mm Cueva Electrode CNE-2X, Cueva Electrode Applicator Wand CNE-100X, Cueva Electrode Leadwire CNE-LW-2DINX.

    FDA Enforcement
    Class II ·Terminated·Ad-Tech Medical Instrument Corporation·October 29, 2014

    Ad-Tech Lightweight TECH ATTACH Cable - Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/stimulators.

    FDA Enforcement
    Class II ·Terminated·Ad-Tech Medical Instrument Corporation·September 29, 2021

    Ad-Tech TECH ATTACH Cable- Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/stimulators.

    FDA Enforcement
    Class II ·Terminated·Ad-Tech Medical Instrument Corporation·September 29, 2021

    Ad-Tech Lightweight CABRIO Cable - Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/stimulators.

    FDA Enforcement
    Class II ·Terminated·Ad-Tech Medical Instrument Corporation·September 29, 2021

    Ad-Tech Electrode Connection System/Cables. Lightweight TECH-ATTACH Cable Models: 1. L-DCL-4DINX (4 contacts: 1 terminal block with 4 connectors each); 2. L-DCL-6DINX (6 contacts: 1 terminal block with 6 connectors each); 3. L-DCL-8DINX (8 contacts: 1 terminal block with 8 connectors each); 4. L-DCL-16BDINX (16 contacts: 1 terminal block with 16 connectors each); 5. L-DCL-32BDINX (32 contacts: 2 terminal blocks with 16 connectors each); 6. L-DCL-64BDINX (64 contacts: 4 terminal blocks with 16 connectors each). FO TECH-ATTACH Connection Cable model FO-LDC-4DINX (4 contacts: 1 terminal block with 4 connectors each). Tech-Attach: these cables require the use of an additional component - the connector block. The tail of the electrode is inserted into the block and the block in turn mates with the cable. A key-pin is used to ensure proper orientation. The cable terminated in EEG compatible connector sockets. Lightweight CABRIO Cable, model L-SRL-64BDINX (64 contacts: 4 terminal blocks with 16 connectors each). Cabrio cables are similar to Tech-Attach cables except that the block portion is pre-attached. The tail of an electrode is inserted into this portion which then hinges shut.

    FDA Enforcement
    Class II ·Terminated·Ad-Tech Medical Instrument Corporation·April 27, 2016

    Disposable Drill Kit which includes two drill bits, two drill stops, and two adjustment wrenches, sterile. The drill bits are 30cm long and made of stainless steel. The drill kits are supplied in a sterile state and are single-use only. Used to drill cranial holes using a stereotactic frame.

    FDA Enforcement
    Class II ·Terminated·Ad-Tech Medical Instrument Corporation·June 6, 2018

    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.

    FDA Enforcement
    Class II ·Terminated·Ad-Tech Medical Instrument Corporation·August 14, 2019

    Dual-Sided Interhemispheric, Grid, Intraoperative, Strip, Wyler Subdural Electrodes

    FDA Enforcement
    Class II ·Terminated·Ad-Tech Medical Instrument Corporation·September 4, 2019

    Skull Anchor Bolts

    FDA Enforcement
    Class II ·Terminated·Ad-Tech Medical Instrument Corporation·September 4, 2019

    Depth Electrodes, Foramen Ovale Depth Electrodes, Macro Micro Depth Electrodes, Spencer Probe Depth Electrodes, Wyler Sphenoidal Depth Electrodes

    FDA Enforcement
    Class II ·Terminated·Ad-Tech Medical Instrument Corporation·September 4, 2019

    AD-TECH Spencer Probe Depth Electrode Product Usage: The Ad-Tech Depth Electrodes (Depth Electrodes, Foramen Ovale Depth Electrodes, Macro Micro Depth Electrodes, Spencer Probe Depth Electrodes, Wyler Sphenoidal Depth Electrodes) are intended for temporary (< 30 days) use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain. The recording of electrical activity supports definition of the location of epileptogenic foci and brain mapping.

    FDA Enforcement
    Class II ·Terminated·Ad-Tech Medical Instrument Corporation·September 4, 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

    FDA Enforcement
    Class II ·Terminated·Ad-Tech Medical Instrument Corporation·September 25, 2019

    AD-TECH Spencer Probe Depth Electrode, REF SD04R-AP58X-000 4-Contact 1.12mm (A style) Depth Electrode

    FDA Enforcement
    Class II ·Completed·Ad-Tech Medical Instrument Corporation·October 30, 2024

    AD-TECH Spencer Probe Depth Electrode, REF SD06R-AP58X-000 6-Contact 1.12mm (A style) Depth Electrode

    FDA Enforcement
    Class II ·Completed·Ad-Tech Medical Instrument Corporation·October 30, 2024

    AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Depth Electrode

    FDA Enforcement
    Class II ·Completed·Ad-Tech Medical Instrument Corporation·October 30, 2024