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Object Status Descending Strength Reference Safety Info
Endoluminal Occlusion System (EOS)
ArtVentive Medical Group, Inc., www.artventivemedical.com 
 Conditional 8

1.5,3 

  Miscellaneous Implants and Devices 
Flow Re-direction Endoluminal Device (FRED)
MicroVention, Inc., www.microvention.com 
 Conditional 8

1.5,3 

  Miscellaneous Implants and Devices 
Integra Camino Flex Ventricular Intracranial Pressure Monitoring Kit
Integra, www.integralife.com 
 Conditional 8

1.5,3 

  Miscellaneous Implants and Devices 
Merit Peritoneal Dialysis Catheter
Merit Medical Systems, www.merit.com 
 Conditional 8

1.5,3 

  Miscellaneous Implants and Devices 
Suture, Stainless Steel Suture, Stainless Wire of Mani
Mani, Inc., Japan  
 Conditional 8

1.5,3 

  Sutures 
Celsite PEEK Vascular Access Port
B. Braun, www.bbraun.com 
 Conditional 8

1.5,3 

  Vascular Access Ports, Infusion Pumps*, Catheters, and Accessories 
Occlutech PDA Occluder
Occlutech, www.occlutech.com 
 Conditional 8

1.5,3 

  Patent Ductus Arteriosus (PDA), Atrial Septal Defect (ASD), Ventricular Septal Defect (VSD) Occluders, and Patent Foramen Ovale Closure Devices 
Occulotech LAA Occluder
Occlutech, www.occlutech.com 
 Conditional 8

1.5,3 

  Patent Ductus Arteriosus (PDA), Atrial Septal Defect (ASD), Ventricular Septal Defect (VSD) Occluders, and Patent Foramen Ovale Closure Devices 
IVT1632, Vascular Access Port With Connector Ring, INFU-KT
ISOMed, www.fbmedical.fr  
 Conditional 8

1.5,3 

  Vascular Access Ports, Infusion Pumps*, Catheters, and Accessories 
Ponto Implant Assembly
Oticon Medical, www.oticonmedical.com 
 Conditional 8

1.5, 3 

  Otologic Implants 
RePneu Coil, Lung Volume Reduction Coil
PneumRx, Inc., www.pneumrx.com 
 Conditional 8

1.5,3 

  Miscellaneous Implants and Devices 
Snowshoe Suture Anchor Pair
USGI Medical, Inc., www.usgimedical.com 
 Conditional 8

1.5,3 

  Miscellaneous Implants and Devices 
PERIFIX Marked Polyamide Epidural Catheter
B. Braun Medical, Inc., www.bbraunusa.com 
 Conditional 8

1.5,3 

  Cardiovascular Catheters, Other Catheters, and Accessories 
AMEND Mitral Annuloplasty Ring
, All Sizes
Valcare Medical LTD., www.valcaremedical.com 
 Conditional 8

1.5, 3 

  Heart Valves and Annuloplasty Rings 
Sterile Repositionable Hemostasis Clipping Device
SureClip
Micro-Tech Co., Ltd., www.micro-tech.com.cn/en 
 Conditional 8

1.5, 3 

  Hemostatic Clips, Other Clips, Fasteners, and Staples 
Edwards SAPIEN 3 Transcatheter Heart Valve Edwards Lifesciences, www.edwards.com    Conditional 8

1.5, 3 

  Heart Valves and Annuloplasty Rings 
Blom-Singer Dual Valve Indwelling Voice Prosthesis
InHealth Technologies, www.inhealth.com 
 Conditional 8

1.5, 3 

  Miscellaneous Implants and Devices 
Blom-Singer Advantage Indwelling Voice Prosthesis
Hard Valve Assembly
InHealth Technologies, www.inhealth.com 
 Conditional 8

1.5, 3 

  Miscellaneous Implants and Devices 
Blom-Singer Advantage Indwelling Voice Prosthesis
Soft Valve Assembly
InHealth Technologies, www.inhealth.com 
 Conditional 8

1.5, 3 

  Miscellaneous Implants and Devices 
Gold Anchor
Naslund Medical AB, www.fineneedlemarker.com 
 Conditional 8

1.5, 3 

  Biopsy Needles, Markers, and Devices 
LOCalizer RFID Breast Lesion Localization System
Health Beacons, www.healthbeacons.com 
 Conditional 8

1.5, 3 

  Biopsy Needles, Markers, and Devices 
Motiva Implant, Ergonomix Round SILKSURFACE Corse with Qid
Establishment Labs S.A., www.establishmentlabs.com  
 Conditional 8

1.5, 3 

  Breast Tissue Expanders and Implants 
Motiva Implant, Round VELVETSURFACE PLUS Corse with Qid
Establishment Labs S.A., www.establishmentlabs.com 
 Conditional 8

1.5, 3 

  Breast Tissue Expanders and Implants 
Motiva Implant, Round SILKSURFACE Corse with Qid
Establishment Labs S.A., www.establishmentlabs.com  
 Conditional 8

1.5, 3 

  Breast Tissue Expanders and Implants 
VolumeView Catheter, VLVF
Edwards Lifesciences, www.edwards.com  
 Conditional 8

1.5, 3 

  Cardiovascular Catheters, Other Catheters, and Accessories 
StrataMR Programmable Valves and Shunts
Medtronic, Inc., www.Medtronic.com/MRI 
 Conditional 8

1.5, 3 

  Cerebrospinal Fluid (CSF) Shunt Valves and Accessories 
Abre Stent
Medtronic, Inc., www.Medtronic.com/MRI 
 Conditional 8

1.5, 3 

  Coils, Filters, Stents, and Grafts 
BioFreedom Drug Coated Stent (DCS)
Biosensors International, www.biosensors.com 
 Conditional 8

1.5, 3 

  Coils, Filters, Stents, and Grafts 
ConvertX Nephroureteral Stent
BrightWater Medical, www.brightwatermed.com  
 Conditional 8

1.5, 3 

  Coils, Filters, Stents, and Grafts 
EluNIR Stent
Medinol Ltd., www.medinol.com 
 Conditional 8

1.5, 3 

  Coils, Filters, Stents, and Grafts 

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