ต วอย าง AF เคร องม อทางการแพทย ท จะศ กษาท ม ความเส ยงน อยและความเส ยงมาก
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1 EXAMPLES: ต วอย าง เคร องม อทางการแพทย ท จะศ กษาท ม ความเส ยงน อยและความเส ยงมาก ต วอย างเคร องม อทางการแพทย ท จะศ กษาท ม ความเส ยงน อย NON-SIGNIFICANT RISK DEVICE STUDIES Bio-stimulation Lasers for treatment of pain Caries Removal Solution Daily Wear Contact Lenses and Associated Cleaners and Solutions Dental Filling Materials, Cushions or Pads made from traditional materials and designs Denture Repair Kits and Re-aligners Gynecologic Laparoscope and Accessories at power levels established prior to May 28, 1976 (excluding use in female sterilization) Externally worn Monitor for Insulin Reactions Jaundice Monitor for Infants Magnetic Resonance Imaging (MRI) Devices within specified physical parameters Menstrual Pads Menstrual Tampons of old materials (used prior to May 28, 1976) Non-implantable Male Reproductive Aids Ob/Gyn Diagnostic Ultrasound (within specified parameters) Transcutaneous Electric Nerve Stimulation (TENS) Devices for treatment of pain Wound Dressings, excluding absorbable hemostatic devices and dressings 1/5
2 EXAMPLES: ต วอย างเคร องม อทางการแพทย ท จะศ กษาท ม ความเส ยงมาก SIGNIFICANT RISK DEVICE STUDIES General Medical Use Catheters: Cardiology diagnostic, treatment, transluminal coronary angioplasty, intra-aortic ballloon with control system Gastroenterology and Urology biliary and urologic General Hospital long-term percutaneous, implanted, subcutaneous and intravascular Neurology cerebrovascular, occlusion balloon Collagen Implant Material for use in ear, nose and throat, orthopedics and plastic surgery Lasers for use in Ob/Gyn, cardiology, gastro-enterology, urology, pulmonary, ophthalmology and neurology Tissue Adhesives for use in neurology, gastro-enterology, ophthalmology, general and plastic surgery, and cardiology Anesthesiology Respiratory Ventilators Electro-anesthesia Apparatus Gas Machines for Anesthesia or Analgesia High Frequency Jet Ventilators greater than 150 BPM Cardiovascular Arterial Embolization Device Artificial Heart, permanent implant and short term use Cardiac Bypass Systems: oxygenator, cardiopulmonary blood pump, ventricular assist devices 2/5
3 Cardiac Pacemaker/Pulse Generator: implantable, external transcutaneous, antitachycardia, esophageal Cardiovascular/Intravascular Filters Coronary Artery Retroperfusion System DC-Defibrillators Implantable Cardioverters Laser Coronary Angioplasty Device Pacemaker Programmer Percutaneous Conduction Tissue Ablation Electrode Replacement Heart Valve Vascular and Arterial Graft Prostheses DENTAL Endosseous Implant Ear, Nose and Throat Cochlear Implant Total Ossicular Prosthesis Replacement Gastroenterology and Urology Anastomosis Device Endoscope and/or Accessories Extracorporeal Hyperthermia System ExtrocorporealPhotophersis System Extracorporeal Shock-Wave Lithotriptor Kidney Perfusion System Mechanical/Hydraulic Impotence and Incontinence Devices Implantable Penile Prosthesis Peritoneal Shunt 3/5
4 General and Plastic Surgery Absorbable Hemostatic Agents Artificial Skin Injectable Silicone Implantable Prostheses: chin, nose, cheek, ear Sutures General Hospital Infusion Pumps: Implantable and closed-loop, depending on infused drug Implantable Vascular Access Devices Neurology Hydrocephalus Shunts Implanted Intracerebral/Subcortical Stimulator Implanted Intracranial Pressure Monitor Impalnted Spinal Cord and Nerve Stimulators and Electrodes Obstetrics and Gynecology Cervical Dilator Chorionic Villus Sampling Catheter, phase II (pregnancy continued to term) Contraceptive Devices: tubal occlusion, cervical cap, diaphragm, intrauterine device (IUD) and introducer, and sponge Ophthalmics Extended Wear Contacts Lens Intraocular Lens (investigations subject to 21 CFR 813) Eye Valve Implant Retinal Reattachment Systems: sulfur hexafluoride, silicone oil, tacks, perfluoropropane 4/5
5 Orthopedics Implantable Prostheses: ligament, tendon, hip, knee, finger Bone Growth Stimulator Calcium Tri-Phosphate/Hydroxyapatite Ceramics Xenografts Radiology Hyperthermia Systems and Applicators 5/5
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