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Object Status Descending Strength Reference Safety Info
Nellix AAA Endoprosthesis
Nellix Endovascular
Palo Alto, CA 
 Conditional 8

1.5,3 

  Coils, Filters, Stents, and Grafts 
Svelte Bare Metal Stent
single and two overlapped versions
Svelte Medical Systems
New Providence, NJ 
 Conditional 8

1.5,3 

  Coils, Filters, Stents, and Grafts 
Silk Artery Reconstruction Device
stent
BALT
France 
 Conditional 8

1.5,3 

  Coils, Filters, Stents, and Grafts 
COMPASS Headframe (Complete)
using fixation, carbon fiber pin, Delrin Sleeve, Carbon Fiber Pin, Delrin Collet w/Nut
COMPASS International, Inc.
Rochester, MN 
 Conditional 8

1.5,3 

  Miscellaneous Implants and Devices 
COMPASS Headframe (Complete)
using fixation, sharp pin, Delrin Sleeve w/Titanium Tip Insert and Delrin Collet w/Nut
COMPASS International, Inc.
Rochester, MN 
 Conditional 8

1.5,3 

  Miscellaneous Implants and Devices 
Advent Cervical Disc
Blackstone Medical, Inc.
Wayne, NJ 
 Conditional 8

1.5,3 

  Orthopedic Implants, Materials, and Devices 
Bryan Cervical Disc System
Medtronic, Inc., www.medtronic.com 
 Conditional 8

1.5,3 

  Orthopedic Implants, Materials, and Devices 
EOI Spinal System EPPS (Expanding Polyaxial Pedicle Screw)
Expanding Orthopedics Inc.
Israel 
 Conditional 8

1.5,3 

  Orthopedic Implants, Materials, and Devices 
Hallmark Anterior Cervical Plate System
Blackstone Medical, Inc.
Wayne, NJ 
 Conditional 8

1.5,3 

  Orthopedic Implants, Materials, and Devices 
NGage Surgical Mesh System
Blackstone Medical, Inc.
Wayne, NJ 
 Conditional 8

1.5,3 

  Orthopedic Implants, Materials, and Devices 
Amplatzer Vascular Graft (AVG)
AGA Medical Corporation
Plymouth, MN 
 Conditional 8

1.5,3 

  Coils, Filters, Stents, and Grafts 
CHOOSTENT
M.I. Tech Co., Ltd., www.mitech.co.kr 
 Conditional 8

1.5,3 

  Coils, Filters, Stents, and Grafts 
Evolution Colonic Stent
Cook Medical, Inc.
www.cookmedical.com 
 Conditional 8

1.5,3 

  Coils, Filters, Stents, and Grafts 
Evolution Duodenal Stent
Cook Medical, Inc.
www.cookmedical.com 
 Conditional 8

1.5,3 

  Coils, Filters, Stents, and Grafts 
Formula Stent
Including Formula Renal Stent
and Formula 414 Rx Renal Stent
Cook Medical, Inc.
www.cookmedical.com 
 Conditional 8

1.5,3 

  Coils, Filters, Stents, and Grafts 
HANAROSTENT
M.I. Tech Co., Ltd., www.mitech.co.kr  
 Conditional 8

1.5,3 

  Coils, Filters, Stents, and Grafts 
HANAROSTENT Esophagus ST (CCN)
M.I. Tech Co., www.mitech.co.kr 
 Conditional 8

1.5,3 

  Coils, Filters, Stents, and Grafts 
MREYE Embolization Coil
Cook Medical, Inc.
www.cookmedical.com 
 Conditional 8

1.5, 3 

  Coils, Filters, Stents, and Grafts 
NEVO Sirolimus-eluting
Coronary Artery Stent
Cordis Corporation 
 Conditional 8

1.5,3 

  Coils, Filters, Stents, and Grafts 
Scuba Stent
Scuba Co-Cr Peripheral Stent
Invatec/Medtronic
www.invatec.com 
 Conditional 8

1.5,3 

  Coils, Filters, Stents, and Grafts 
Treovance Abdominal Stent Graft
Bolton Medical, Inc.
Sunrise, FL 
 Conditional 8

1.5,3 

  Coils, Filters, Stents, and Grafts 
X-Suit NIR Covered Biliary Stent
Medinol Ltd., Israel 
 Conditional 8

1.5,3 

  Coils, Filters, Stents, and Grafts 
Zenith Spiral-Z AAA Iliac Leg Graft
Cook Medical, Inc.
www.cookmedical.com 
 Conditional 8

1.5,3 

  Coils, Filters, Stents, and Grafts 
Zilver 6 Fr Flex Stent
Cook Medical, Inc.
www.cookmedical.com 
 Conditional 8

1.5,3 

  Coils, Filters, Stents, and Grafts 
Zilver Flex 35 Biliary Stent
Cook Medical, Inc.
www.cookmedical.com 
 Conditional 8

1.5,3 

  Coils, Filters, Stents, and Grafts 
ZILVER FLEX 35 Vascular Stent
Cook Medical, Inc.
www.cookmedical.com 
 Conditional 8

1.5,3 

  Coils, Filters, Stents, and Grafts 
Zilver PTX Drug Eluting
Peripheral Stent
Cook Medical, Inc.
www.cookmedical.com 
 Conditional 8

1.5,3 

  Coils, Filters, Stents, and Grafts 
Zimmon Pancreatic Stent
Cook Medical, Inc.
www.cookmedical.com 
 Conditional 8

1.5,3 

  Coils, Filters, Stents, and Grafts 
Implantable Miniature Telescope
VisionCare Ophthalmic Technologies, Inc., www.visioncareinc.net 
 Conditional 8

1.5, 3 

  Ocular Implants, Lens Implants, and Devices 
Cougar Lateral Cage System
DePuy
www.DePuy.com 
 Conditional 8

1.5,3 

  Orthopedic Implants, Materials, and Devices 

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