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- 21 CFR 882.5175 · Carotid artery clamp.
- 21 CFR 882.5200 · Aneurysm clip.
- 21 CFR 882.5225 · Implanted malleable clip.
- 21 CFR 882.5235 · Aversive conditioning device.
- 21 CFR 882.5250 · Burr hole cover.
- 21 CFR 882.5275 · Nerve cuff.
- 21 CFR 882.5300 · Methyl methacrylate for cranioplasty.
- 21 CFR 882.5320 · Preformed alterable cranioplasty plate.
- 21 CFR 882.5330 · Preformed nonalterable cranioplasty plate.
- 21 CFR 882.5360 · Cranioplasty plate fastener.
- 21 CFR 882.5500 · Lesion temperature monitor.
- 21 CFR 882.5550 · Central nervous system fluid shunt and components.
- 21 CFR 882.5560 · Cerebrospinal fluid shunt system.
- 21 CFR 882.5600 · Neurovascular mechanical thrombectomy device for acute ischemic stroke treatment.
- 21 CFR 882.5700 · Thermal system for insomnia.
- 21 CFR 882.5705 · Digital therapy device to reduce sleep disturbance for psychiatric conditions.
- 21 CFR 882.5800 · Cranial electrotherapy stimulator.
- 21 CFR 882.5801 · Computerized behavioral therapy device for psychiatric disorders.
- 21 CFR 882.5802 · Transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions.
- 21 CFR 882.5803 · Digital therapy device for Attention Deficit Hyperactivity Disorder.
- 21 CFR 882.5804 · Computerized behavioral therapy device for the treatment of fibromyalgia symptoms.
- 21 CFR 882.5805 · Repetitive transcranial magnetic stimulation system.
- 21 CFR 882.5808 · Transcranial magnetic stimulator for headache.
- 21 CFR 882.5810 · External functional neuromuscular stimulator.
- 21 CFR 882.5820 · Implanted cerebellar stimulator.
- 21 CFR 882.5830 · Implanted diaphragmatic/phrenic nerve stimulator.
- 21 CFR 882.5840 · Implanted intracerebral/subcortical stimulator for pain relief.
- 21 CFR 882.5850 · Implanted spinal cord stimulator for bladder evacuation.
- 21 CFR 882.5855 · Brain stimulation programming planning software.
- 21 CFR 882.5860 · Implanted neuromuscular stimulator.
- 21 CFR 882.5870 · Implanted peripheral nerve stimulator for pain relief.
- 21 CFR 882.5880 · Implanted spinal cord stimulator for pain relief.
- 21 CFR 882.5887 · External lower extremity nerve stimulator for Restless Legs Syndrome.
- 21 CFR 882.5888 · Transcutaneous electrical nerve stimulator to treat fibromyalgia symptoms.
- 21 CFR 882.5889 · Electrical tongue nerve stimulator to treat motor deficits.
- 21 CFR 882.5890 · Transcutaneous electrical nerve stimulator for pain relief.
- 21 CFR 882.5891 · Transcutaneous electrical nerve stimulator to treat headache.
- 21 CFR 882.5892 · External vagal nerve stimulator for headache.
- 21 CFR 882.5893 · Thermal vestibular stimulator for headache.
- 21 CFR 882.5894 · Limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites.
- 21 CFR 882.5895 · Vibratory counter-stimulation device.
- 21 CFR 882.5896 · Percutaneous nerve stimulator for substance use disorders.
- 21 CFR 882.5897 · External upper limb tremor stimulator.
- 21 CFR 882.5898 · Transcutaneous electrical nerve stimulator for attention deficit hyperactivity disorder.
- 21 CFR 882.5899 · Trunk and limb electrical stimulator to treat headache.
- 21 CFR 882.5900 · Preformed craniosynostosis strip.
- 21 CFR 882.5910 · Dura substitute.
- 21 CFR 882.5940 · Electroconvulsive therapy device.
- 21 CFR 882.5950 · Neurovascular embolization device.
- 21 CFR 882.5955 · Temporary coil embolization assist device.
- 21 CFR 882.5960 · Skull tongs for traction.
- 21 CFR 882.5970 · Cranial orthosis.
- 21 CFR 884.1 · Scope.
- 21 CFR 884.3 · Effective dates of requirement for premarket approval.
- 21 CFR 884.9 · Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
- 21 CFR 884.1040 · Viscometer for cervical mucus.
- 21 CFR 884.1050 · Endocervical aspirator.
- 21 CFR 884.1060 · Endometrial aspirator.
- 21 CFR 884.1100 · Endometrial brush.
- 21 CFR 884.1175 · Endometrial suction curette and accessories.
- 21 CFR 884.1185 · Endometrial washer.
- 21 CFR 884.1300 · Uterotubal carbon dioxide insufflator and accessories.
- 21 CFR 884.1425 · Perineometer.
- 21 CFR 884.1550 · Amniotic fluid sampler (amniocentesis tray).
- 21 CFR 884.1560 · Fetal blood sampler.
- 21 CFR 884.1600 · Transabdominal amnioscope (fetoscope) and accessories.
- 21 CFR 884.1630 · Colposcope.
- 21 CFR 884.1640 · Culdoscope and accessories.
- 21 CFR 884.1660 · Transcervical endoscope (amnioscope) and accessories.
- 21 CFR 884.1690 · Hysteroscope and accessories.
- 21 CFR 884.1700 · Hysteroscopic insufflator.
- 21 CFR 884.1710 · Closed loop hysteroscopic insufflator with cutter-coagulator.
- 21 CFR 884.1720 · Gynecologic laparoscope and accessories.
- 21 CFR 884.1730 · Laparoscopic insufflator.
- 21 CFR 884.2050 · Obstetric data analyzer.
- 21 CFR 884.2225 · Obstetric-gynecologic ultrasonic imager.
- 21 CFR 884.2600 · Fetal cardiac monitor.
- 21 CFR 884.2620 · Fetal electroencephalographic monitor.
- 21 CFR 884.2640 · Fetal phonocardiographic monitor and accessories.
- 21 CFR 884.2660 · Fetal ultrasonic monitor and accessories.
- 21 CFR 884.2675 · Fetal scalp circular (spiral) electrode and applicator.
- 21 CFR 884.2685 · Fetal scalp clip electrode and applicator.
- 21 CFR 884.2700 · Intrauterine pressure monitor and accessories.
- 21 CFR 884.2720 · External uterine contraction monitor and accessories.
- 21 CFR 884.2730 · Home uterine activity monitor.
- 21 CFR 884.2740 · Perinatal monitoring system and accessories.
- 21 CFR 884.2800 · Computerized Labor Monitoring System.
- 21 CFR 884.2900 · Fetal stethoscope.
- 21 CFR 884.2960 · Obstetric ultrasonic transducer and accessories.
- 21 CFR 884.2980 · Telethermographic system.
- 21 CFR 884.2982 · Liquid crystal thermographic system.
- 21 CFR 884.2990 · Breast lesion documentation system.
- 21 CFR 884.3200 · Cervical drain.
- 21 CFR 884.3575 · Vaginal pessary.
- 21 CFR 884.3650 · Fallopian tube prosthesis.
- 21 CFR 884.3900 · Vaginal stent.
- 21 CFR 884.4050 · Gynecologic laparoscopic power morcellation containment system.
- 21 CFR 884.4100 · Endoscopic electrocautery and accessories.
- 21 CFR 884.4120 · Gynecologic electrocautery and accessories.
- 21 CFR 884.4150 · Bipolar endoscopic coagulator-cutter and accessories.