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Object Status Ascending Strength Reference Safety Info
Titan Wireless Implantable Hemodynamic Monitoring (WIHM) System
Integrated Sensing Systems, Inc., www.mems-issys.com 
 Conditional 8

1.5,3 

  Miscellaneous Implants and Devices 
C Stem, Small and Large Assembly
DePuy International Ltd., www.depuy.com 
 Conditional 8

1.5,3 

  Orthopedic Implants, Materials, and Devices 
C Stem, Small and Large Assembly
DePuy International Ltd., www.depuy.com 
 Conditional 8

1.5,3 

  Orthopedic Implants, Materials, and Devices 
Conserve BFH Total Hip System
Wright Medical Technology, www.wmt.com 
 Conditional 8

1.5,3 

  Orthopedic Implants, Materials, and Devices 
Facet Screw and Polyaxial Washer and Polyaxial Washer
Facet-Link, Inc., Rockaway, NJ 
 Conditional 8

1.5,3 

  Orthopedic Implants, Materials, and Devices 
Facet-Link, Standard Device
Facet-Link, Inc., Rockaway, NJ 
 Conditional 8

1.5,3 

  Orthopedic Implants, Materials, and Devices 
HEMI 8-mm Large Buttress, Left and Two Facet Screws (5-mm x 55-mm)
Facet-Link, Inc., Rockaway, NJ 
 Conditional 8

1.5,3 

  Orthopedic Implants, Materials, and Devices 
IFuse Implant, L Implant
including multiple implant configurations with 2 to 4 implants, SI-BONE, www.si-bone.comSI Bone, www.si-bone.com 
 Conditional 8

1.5,3 

  Orthopedic Implants, Materials, and Devices 
Inbone Total Ankle System
Wright Medical Technology, www.wmt.com 
 Conditional 8

1.5,3 

  Orthopedic Implants, Materials, and Devices 
LCS Complete Assembly, Small and Large
DePuy International Ltd., www.depuy.com  
 Conditional 8

1.5,3 

  Orthopedic Implants, Materials, and Devices 
OrthoFuzIon Cannulated Screw System
Silver Bullet Therapeutics Inc., San Jose, CA 
 Conditional 8

1.5,3 

  Orthopedic Implants, Materials, and Devices 
Reef Stem/Octopus Acetabular Assembly
DePuy International Ltd., www.depuy.com 
 Conditional 8

1.5,3 

  Orthopedic Implants, Materials, and Devices 
Silent Stem Assembly
DePuy International Ltd., www.depuy.com 
 Conditional 8

1.5,3 

  Orthopedic Implants, Materials, and Devices 
Univers II Humeral Stem
Arthrex, www.arthrex.com 
 Conditional 8

1.5,3 

  Orthopedic Implants, Materials, and Devices 
WOMBAT ST Spinal Implant
SIGNUS Medizintechnik GmbH, www.signus-med.de 
 Conditional 8

1.5,3 

  Orthopedic Implants, Materials, and Devices 
MOBIS II ST Spinal Implant
SIGNUS Medizintechnik GmbH, www.signus-med.de  
 Conditional 8

1.5,3 

  Orthopedic Implants, Materials, and Devices 
Surgical Stainless Steel Wire Suture
Ethicon Surgical Care, www.ethicon.com 
 Conditional 8

1.5,3 

  Sutures 
Nexus Septal Occluder
W.L. Gore & Associates, www.goremedical.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 
Mobi-C Cervical Disc Prosthesis
LDR Spine, http://www.ldr.com/ 
 Conditional 8

1.5,3 

  Orthopedic Implants, Materials, and Devices 
Sternum Band
Johnson & Johnson Meical GmbH, www.jnjmedical.de 
 Conditional 8

1.5,3 

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

1.5,3 

  Cardiovascular Catheters, Other Catheters, and Accessories 
Marked Polyamide Epidural Catheter, Closed Tip
B. Braun Medical, Inc., www.bbraunusa.com 
 Conditional 8

1.5,3 

  Cardiovascular Catheters, Other Catheters, and Accessories 
Neucrylate, Liquid Embolic System
Valor Medical, www.valormedical.com 
 Conditional 8

1.5,3 

  Miscellaneous Implants and Devices 
Laminate External Support
Laminate Medical Technologies Ltd., Israel 
 Conditional 8

1.5,3 

  Miscellaneous Implants and Devices 
Gen 6.0 HeRO, The Adapter
Hemosphere, Inc., Eden Prairie, MN 
 Conditional 8

1.5,3 

  Miscellaneous Implants and Devices 
FlexTip Plus Epidural Catheter, 19-gauge x 90-cm, Nonmagnetic SS Version
Teleflex Medical, Inc., www.teleflex.com 
 Conditional 8

1.5,3 

  Cardiovascular Catheters, Other Catheters, and Accessories 
Champion HF Pressure Sensor
CardioMEMS HF System
CardioMEMS, Inc., www.sjm.com/cardiomems 
 Conditional 8

1.5,3 

  Miscellaneous Implants and Devices 
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 
AMEND Mitral Annuloplasty Ring
, All Sizes
Valcare Medical LTD., www.valcaremedical.com 
 Conditional 8

1.5, 3 

  Heart Valves and Annuloplasty Rings 
GORE CARDIOFORM Septal Occluder
W. L. Gore and Associates, Inc., www.wlgore.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 

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