FDA’s List of Potentially High-risk Medical Devices
FDA’s List of Potentially High-risk Medical Devices
CLASSIFIED DEVICES (with classification regulation number followed by classification name):
• 862.1345 glucose test system
• 862.2140 centrifugal chemistry analyzer for clinical use
• 862.2150 continuous flow sequential multiple chemistry analyzer for clinical use
• 862.2160 discrete photometric chemistry analyzer for clinical use
• 862.2170 microchemistry analyzer for clinical use
• 868.1150 indwelling blood carbon dioxide partial pressure (PCO2) analyzer
• 868.1200 indwelling blood oxygen partial pressure (Po2) analyzer
• 868.1730 oxygen-uptake computer
• 868.2375 breathing frequency monitor
• 868.2450 lung water monitor
• 868.5160 gas machine for anesthesia or analgesia
• 868.5330 breathing gas mixer
• 868.5400 electroanesthesia apparatus
• 868.5440 portable oxygen generator
• 868.5470 hyperbaric chamber
• 868.5610 membrane lung (for long-term pulmonary support)
• 868.5830 autotransfusion apparatus
• 868.5880 anesthetic vaporizer
• 868.5895 continuous ventilator
• 868.5925 powered emergency ventilator
• 868.5935 external negative pressure ventilator
• 868.5955 intermittent mandatory ventilation attachment
• 870.1025 arrhythmia detector and alarm
• 870.1750 external programmable pacemaker pulse generator
• 870.3535 intra-aortic balloon and control system
• 870.3545 ventricular bypass (assist) device
• 870.3600 external pacemaker pulse generator
• 870.3610 implantable pacemaker pulse-generator
• 870.3700 pacemaker programmers
• 870.4220 cardiopulmonary bypass heart-lung machine console
• 870.4320 cardiopulmonary bypass pulsatile flow generator
• 870.4330 cardiopulmonary bypass on-line blood gas monitor
• 870.4360 nonroller-type cardiopulmonary bypass blood pump
• 870.4370 roller-type cardiopulmonary bypass blood pump
• 870.4380 cardiopulmonary bypass pump speed control
• 870.5225 external counter-pulsating device
• 870.5300 dc-defibrillator low energy (including paddles)
• 876.5270 implanted electrical urinary continence device
• 876.5630 peritoneal dialysis system and accessories
• 876.5820 hemodialysis systems and accessories
• 876.5860 high permeability hemodialysis system
• 876.5870 sorbent hemoperfusion system
• 876.5880 isolated kidney perfusion and transport system and accessories
• 880.5130 infant radiant warmer
• 880.5400 neonatal incubator
• 880.5410 neonatal transport incubator
• 880.5725 infusion pump
• 882.5820 implanted cerebellar stimulator
• 882.5830 implanted diaphragmatic/phrenic nerve stimulator
• 882.5840 implanted intracerebral/subcortical stimulator for pain relief
• 882.5850 implanted spinal cord stimulator for bladder evacuation
• 882.5860 implanted neuromuscular stimulator
• 882.5870 implanted peripheral nerve stimulator for pain relief
• 882.5880 implanted spinal cord stimulator for pain relief
• 884.1700 hysteroscopic insufflator
• 884.1730 laparoscopic insufflator
• 884.2660 fetal ultrasonic monitor and accessories
The following device classifications include radiation treatment planning systems that are accessories to these device types:
• 892.5050 medical charged-particle radiation therapy system
• 892.5300 medical neutron radiation therapy system
• 892.5700 remote-controlled radionuclide-applicator system
• 892.5750 radionuclide radiation therapy system
• 892.5900 X-ray radiation therapy system
Post-medical device amendments Class III devices, and devices not yet classified:
• Ventilator, high-frequency
• Cardioconverter, implantable
• Defibrillator, automatic implantable cardioverter
• Defibrillator, implantable, dual chamber
• Pulse-generator, dual chamber, implantable
• Pulse-generator, program module
• Pulse-generator, single chamber, sensor driven, implantable
• Pulse-generator, single chamber
• System, pacing, temporary, acute, internal atrial defibrillation
• Automated blood cell and plasma separator for therapeutic purposes
• Lipoprotein, low density, removal
• Separator for therapeutic purposes, membrane automated blood cell/plasma
• Pump, drug administration, closed loop
• Pump, infusion, implanted, programmable
• Kit, test, alpha-fetoprotein for neural tube defects
• Stimulator, cortical, implanted for pain
• Stimulator, electrical, implanted, for parkinsonian tremor
• Stimulator, sacral nerve, implanted
• Stimulator, spinal-cord, totally implanted for pain relief
• Stimulator, subcortical, implanted for epilepsy
• Device, thermal ablation, endometrial
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