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CADWELL INDUSTRIES INC

CASCADE · Neurology

510(k): 1 Recall: 2 UDI: 26 MAUDE: 2 Class.: 62

510(k) Clearances (1)

Cascade IOMAX Intraoperative Monitor

2017-03-02

Substantially Equivalent

Recalls (2)

Cascade IOMAX Cortical Module, REF: 190296-200

2024-05-17

Electroneurodiagnostic medical device may contain a defective printed circuit board which may cause damage to the other internal components resulting in unintended electrical stimulation.

Cascade IOMAX Cortical Module, REF: 190296-200

2024-04-23

There is the potential that an electroneurodiagnostic medical device insulator may be installed incorrectly which could result in arcing to patient connections resulting in potential unintended shock to the patient.

UDI Registrations (26)

Cascade Elite

Cascade IOMAX

Cascade IOMAX VEP LED Goggles

Cascade

ES5-5 Stim Splitter

Cascade IOMAX

LOW CURRENT INTERFACE CABLE

Cascade

Cascade 16Ch Amplifier

Cascade

ES Detect Interface

Cascade IOMAX Intraoperative Monitor

Cascade IOMAX Limb Module

Cascade Extender Pod

Cascade Remote Input Extender Pods; Quickconnect; 3 Meter

Cascade IOMAX Intraoperative Monitor

LCSwap IOMAX

Cascade

Cascade TCS-4

Cascade IOMAX

IOMAX EARPHONE INSERT CABLE

Cascade

Cascade TCS-1000

Cascade IOMAX Intraoperative Monitor

Cascade IOMAX Cortical Module

Cascade IOMAX

Iomax Earphone Insert Cable

Cascade Pro

Cascade Pro Base

Cascade IOMAX Intraoperative Monitor

IOMAX 3M VEP LED GOGGLES

Cascade Extender Pod

Cascade Remote Input Extender Pods; Quickconnect; 6 Meter

Cascade

Cascade Base

Cascade

ES-IX Stimulator

Cascade

Cascade ES16

Cascade Elite

Cascade Elite Power/Com Module

Cascade Elite

Cascade VEP/LED Quick Connect Goggles

Cascade

ES5-100; Stim Splitter

Cascade IOMAX Intraoperative Monitor

Cascade IOMAX Base Module

Cascade IOMAX Intraoperative Monitor

IOMAX 32 Channel Amplifier

Cascade

ES5-20 Stim Splitter

MAUDE Adverse Events (2)

Malfunction

20160518

Malfunction

20160428

FDA Classification (62)

Orthopedic Stereotaxic Instrument

Neurology

Drills, Burrs, Trephines, And Accessories (Powered Compound), Reprocessed

Neurology

Electrode, Cutaneous

Neurology

Catheter, Intravascular Occluding

Neurology

Endoscopic Shunt Placement Kit

Neurology

Conditioner, Signal, Physiological

Neurology

Generator, Lesion, Radiofrequency

Neurology

Stimulator, Mechanical, Evoked Response

Neurology

Non-Invasive Evoked Response Brain Stimulator

Neurology

In Situ Polymerizing Peripheral Nerve Cap

Neurology

Cranial Electrotherapy Stimulator To Treat Depression

Neurology

Block, Bite

Neurology

Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder

Neurology

Transcutaneous Nerve Stimulator For Adhd

Neurology

Chair, Neurosurgical

Neurology

Computerized Cognitive Assessment Aid For Concussion

Neurology

Field Generator Positioning Device

Neurology

Leukotome

Neurology

Neuromuscular Stimulator And Exercise Evaluation System

Neurology

Device, Monitoring, Intracranial Pressure

Neurology

Cranial Surgical Planning And Instrument Guides

Neurology

Transcranial Magnetic Stimulation System For Post Traumatic Stress Disorder (Ptsd)

Neurology

Tracking, Soft Tissue, Intraoperative

Neurology

Device, Surgical, Cryogenic

Neurology

Clip, Aneurysm

Neurology

Thermal Vestibular Stimulator For Headache

Neurology

Amplitude-Integrated Electroencephalograph

Neurology

Electromagnetic Stimulator, Pain Relief

Neurology

Computerized Behavioral Therapy Device For Anxiety Disorders

Neurology

Computer Assisted Hair Harvesting System

Neurology

Nystagmograph

Neurology

Holder, Head, Neurosurgical (Skull Clamp)

Neurology

Device, Sleep Assessment

Neurology

Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine

Neurology

Anvil, Skull Plate

Neurology

Burst Suppression Detection Software For Electroencephalograph

Neurology

Rongeur, Powered

Neurology

Patient Specific Manual Orthopedic Stereotaxic System

Neurology

Transcranial Nerve Stimulation Device For The Treatment Of Post-Traumatic Stress Disorder Associated Symptoms

Neurology

Rongeur, Manual

Neurology

Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch

Neurology

Electrode, Spinal Epidural

Neurology

Index-Generating Electroencephalograph Software

Neurology

Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid

Neurology

Computerized Behavioral Therapy Device For Migraine

Neurology

Filler, Bone Void, Non-Alterable Compound For Cranioplasty

Neurology

Automatic Event Detection Software For Polysomnograph With Electroencephalograph

Neurology

Stimulator, Nerve, Transcutaneous, For Pain Relief

Neurology

Normalizing Quantitative Electroencephalograph Software

Neurology

Brain Intraparenchymal Infusion Cannula

Neurology

Pinwheel

Neurology

Parkinsonian Syndrome Diagnostic Aid

Neurology

Needle, Neurosurgical Suture

Neurology

Cranial Distraction System

Neurology

Drills, Burrs, Trephines And Accessories (Simple Powered), Reprocessed

Neurology

Stimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief

Neurology

Evoked Photon Image Capture Device

Neurology

Instrument, Dowel Cutting

Neurology

Instrument, Surgical, Non-Powered

Neurology

Automatic Event Detection Software For Full-Montage Electroencephalograph

Neurology

Catheter, Neuro-Vasculature, Occluding Balloon

Neurology

Pain Assessment Software In Non-Communicative Adults

Neurology