|  |  | | Solo Smart Heart Valve ProsthesisSorin Group, www.sorin.com
 | 
 | 1.5,3 | Safe
	 
		
			
				
					More... | Heart Valves and Annuloplasty Rings
	 
		
			
				
					More... | 
										
											
							
																														
									
	|  |  | | Solo Tympanostomy Tube DeviceVentilation Tube
 Otologic implant
 High Density Polyethylene (HDPE)
 AventaMed, www.aventamed.com
 | 
 | 1.5, 3 | Safe
	 
		
			
				
					More... | Otologic Implants
	 
		
			
				
					More... | 
										
											
							
																														
									
	|  |  | | Solo+ Tympanostomy Tube Device (TTD)
 Ventilation Tube
 Otologic implant 316L stainless steel, silicone AventaMed, www.aventamed.com | 
 | 3 | Conditional 6
	 
		
			
				
					More... | Otologic Implants
	 
		
			
				
					More... | 
										
											
							
																														
									
	|  |  | | Solus Anterior Lumbar Interbody Fusion (ALIF)Alphatec Spine Inc., www.alphatecspine.com
 | 
 | 3 | Conditional 6
	 
		
			
				
					More... | Orthopedic Implants, Materials, and Devices
	 
		
			
				
					More... | 
										
											
							
																														
									
	|  |  | | Solus Double Pigtail StentCook Medical, Inc.
 www.cookmedical.com
 | 
 | 3 | Conditional 6
	 
		
			
				
					More... | Coils, Filters, Stents, and Grafts
	 
		
			
				
					More... | 
										
											
							
																														
									
	|  |  | | SOLX Gold ShuntSOLX, Inc, www.solx.com
 | 
 | 1.5, 3 | Conditional 8
	 
		
			
				
					More... | Ocular Implants, Lens Implants, and Devices
	 
		
			
				
					More... | 
										
											
							
																														
									
	|  |  | | Solyx SIS(Single Incision Sling) System
 Boston Scientific Corporation
 Marlborough, MA
 | 
 | 1.5,3 | Safe
	 
		
			
				
					More... | Miscellaneous Implants and Devices
	 
		
			
				
					More... | 
										
											
							
																														
									
	|  |  | | SONIC Micro-CatheterBalt, www.balt.fr/en
 | 
 | 1.5 | Unsafe 1
	 
		
			
				
					More... | Cardiovascular Catheters, Other Catheters, and Accessories
	 
		
			
				
					More... | 
										
											
							
																														
									
	|  |  | | SOPH-A-PORT Mini Spinal Implantable Access PortSophysa, www.sophysa.com
 | 
 | 3 | Conditional 5
	 
		
			
				
					More... | Vascular Access Ports, Infusion Pumps*, Catheters, and Accessories
	 
		
			
				
					More... | 
										
											
							
																														
									
	|  |  | | Sophy adjustable pressure valve | 
 | 1.5 | Conditional 5
	 
		
			
				
					More... | Cerebrospinal Fluid (CSF) Shunt Valves and Accessories
	 
		
			
				
					More... | 
										
											
							
																														
									
	|  |  | | SOPHY Adjustable Pressure ValveSophysa USA, Inc.
 www.sophysa.com
 | 
 | 1.5 | Conditional 5
	 
		
			
				
					More... | Cerebrospinal Fluid (CSF) Shunt Valves and Accessories
	 
		
			
				
					More... | 
										
											
							
																														
									
	|  |  | | Sophy adjustable pressure valvemisc.
 | 
 | 1.5 | Conditional 5
	 
		
			
				
					More... | Cerebrospinal Fluid (CSF) Shunt Valves and Accessories
	 
		
			
				
					More... | 
										
											
							
																														
									
	|  |  | | Sophy programmable pressure valveModel SM8
 misc.
 Sophysa
 Orsay, France
 | 
 | 1.5 | Conditional 5
	 
		
			
				
					More... | Cerebrospinal Fluid (CSF) Shunt Valves and Accessories
	 
		
			
				
					More... | 
										
											
							
																														
									
	|  |  | | Sophy programmable pressure valveModel SM8
 Sophysa
 Orsay, France
 | 
 | 1.5 | Conditional 5
	 
		
			
				
					More... | Cerebrospinal Fluid (CSF) Shunt Valves and Accessories
	 
		
			
				
					More... | 
										
											
							
																														
									
	|  |  | | Sophy programmable pressure valveModel SP3
 misc.
 Sophysa
 Orsay, France
 | 
 | 1.5 | Conditional 5
	 
		
			
				
					More... | Cerebrospinal Fluid (CSF) Shunt Valves and Accessories
	 
		
			
				
					More... | 
										
											
							
																														
									
	|  |  | | Sophy programmable pressure valveModel SU8
 Sophysa
 Orsay, France
 | 
 | 1.5 | Conditional 5
	 
		
			
				
					More... | Cerebrospinal Fluid (CSF) Shunt Valves and Accessories
	 
		
			
				
					More... | 
										
											
							
																														
									
	|  |  | | Sophysa SOPH-A-PORT Mini SImplantable Access Port
 Shire, www.shire.com
 | 
 | 1.5, 3 | Conditional 8
	 
		
			
				
					More... | Vascular Access Ports, Infusion Pumps*, Catheters, and Accessories
	 
		
			
				
					More... | 
										
											
							
																														
									
	|  |  | | Soprano Armonia Heart Valve ProsthesisSorin Group, www.sorin.com
 | 
 | 3 | Conditional 6
	 
		
			
				
					More... | Heart Valves and Annuloplasty Rings
	 
		
			
				
					More... | 
										
											
							
																														
									
	|  |  | | Sorin Allcarbon, ASModel MTR-29AS, 29 mm
 pyrolitic carbon
 Heart Valve
 Sorin Biomedica Cardio S.p.A.
 Saluggia, Italy
 | 
 | 1.5 | Conditional 5
	 
		
			
				
					More... | Heart Valves and Annuloplasty Rings
	 
		
			
				
					More... | 
										
											
							
																														
									
	|  |  | | Sorin Pericarbon (stented)Mitral
 pyrolytic carbon
 Heart Valve
 Sorin Biomedica
 Italy
 | 
 | 1.5 | Conditional 5
	 
		
			
				
					More... | Heart Valves and Annuloplasty Rings
	 
		
			
				
					More... |