ClearanceBrief
Panels › Anesthesiology

Anesthesiology devices

199 product codes reviewed by the Anesthesiology panel. 8,428 510(k) clearances and 3,297 recalls in the FDA data, 57% of those recalls name a 510(k).

98510(k)s in 12 months
183recalls in 12 months
1,885recalls that name a 510(k)

Active product codes, Class II

CodeDeviceClass510(k)s, 12 moRecalls, 12 mo
CBKVentilator, Continuous, Facility Use2423
OFTSpinal Epidural Anesthesia Kit2016
BZDVentilator, Non-Continuous (Respirator)2123
BSZGas-Machine, Anesthesia2212
CAZAnesthesia Conduction Kit2113
NHJDevice, Positive Pressure Breathing, Intermittent2212
CAWGenerator, Oxygen, Portable2121
OGJNerve Block Tray209
NDCCalculator, Drug Dose253
OGEEpidural Anesthesia Kit208
MNRVentilatory Effort Recorder261
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)251
JOHTube Tracheostomy And Tube Cuff215
BZTStethoscope, Esophageal, With Electrical Conductors213
CAFNebulizer (Direct Patient Interface)240
MNSVentilator, Continuous, Non-Life-Supporting231
MODAccessory To Continuous Ventilator (Respirator)231
BTMVentilator, Emergency, Manual (Resuscitator)221
BTRTube, Tracheal (W/Wo Connector)221
CAHFilter, Bacterial, Breathing-Circuit221
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase230
MRNApparatus, Nitric Oxide Delivery212
OFQAnesthesia Kit203
OFUSpinal Anesthesia Kit203
BSKCuff, Tracheal Tube, Inflatable211
BSOCatheter, Conduction, Anesthetic202
BTOTube, Tracheostomy (W/Wo Connector)211
BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer220
BZHMeter, Peak Flow, Spirometry220
BZQMonitor, Breathing Frequency220
CADVaporizer, Anesthesia, Non-Heated202
CBITube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)220
NXATracheotomy Care Kit202
OGDCustom Anesthesia Tray202
PHZAbnormal Breath Sound Device220
SGRNoninvasive Positive Airway Pressure System, Facility Use220
BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)201
BTYCalculator, Predicted Values, Pulmonary Function210
BWCNeedle, Emergency Airway201
BYEAttachment, Breathing, Positive End Expiratory Pressure201
BYIPercussor, Powered-Electric210
BZGSpirometer, Diagnostic210
BZKSpirometer, Monitoring (W/Wo Alarm)210
CAPMonitor, Airway Pressure (Includes Gauge And/Or Alarm)210
CCJAnalyzer, Gas, Carbon-Monoxide, Gaseous-Phase210
CCLAnalyzer, Gas, Oxygen, Gaseous-Phase210
KOIStimulator, Nerve, Peripheral, Electric210
MNTContinuous, Minimal Ventilatory Support, Facility Use Ventilator210
NOUContinuous, Ventilator, Home Use201
OGGHumidifier Nebulizer Kit201
QVCVentilator Waveform Analysis Software210
QZWOver-The-Counter Device To Assess Risk Of Sleep Apnea210
SFPVentilator-Compatible Nebulizer210
SHJThrombectomy Whole Blood Return System210

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