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Object Status Descending Strength Reference Safety Info
GORE Carotid Stent
W.L. Gore and Associates, www.goremedical.com 
 Conditional 8

1.5, 3 

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

1.5, 3 

  Coils, Filters, Stents, and Grafts 
Penumbra Coil, Embolization Coil
Penumbra, Inc., www.penumbrainc.com 
 Conditional 8

1.5, 3 

  Coils, Filters, Stents, and Grafts 
Penumbra Coil 400, Embolization Coil
Penumbra, Inc., www.penumbrainc.com 
 Conditional 8

1.5, 3 

  Coils, Filters, Stents, and Grafts 
Penumbra Occlusion Coil, POD, Embolization Coil
Penumbra, Inc., www.penumbrainc.com 
 Conditional 8

1.5, 3 

  Coils, Filters, Stents, and Grafts 
Penumbra Smart Coil, Embolization Coil
Penumbra Inc., www.penumbrainc.com 
 Conditional 8

1.5, 3 

  Coils, Filters, Stents, and Grafts 
Ruby Coil, Embolization Coil
Penumbra, Inc., www.penumbrainc.com 
 Conditional 8

1.5, 3 

  Coils, Filters, Stents, and Grafts 
Blue Sensor, Model 2300
ECG (EKG) Electrode
Ambu, www.ambu.com 
 Conditional 8

1.5, 3 

  ECG (EKG) Electrodes 
WhiteSensor, Models 0215M, 0315M, 0415M
0615M, 0715M, WS/RT, 4841P, 7841P, 4530M,
4540M, 4570M, 40713, 4440M, 4500M
ECG (EKG) Electrode
Ambu, www.ambu.com 
 Conditional 8

1.5, 3 

  ECG (EKG) Electrodes 
Crown PRT Aortic Pericardial Heart Valve
LivaNova, www.livanova.sorin.com 
 Conditional 8

1.5, 3 

  Heart Valves and Annuloplasty Rings 
FlexForm Annuloplasty Ring
Genesee BioMedical, Inc., www.geneseebiomedical.com 
 Conditional 8

1.5, 3 

  Heart Valves and Annuloplasty Rings 
DuraClip
Conmed Corporation, www.conmed.com 
 Conditional 8

1.5, 3 

  Hemostatic Clips, Other Clips, Fasteners, and Staples 
3D Interstitial Ring Applicator 90 with Plastic Needles
Varian Medical Systems, www.varian.com 
 Conditional 8

1.5, 3 

  Miscellaneous Implants and Devices 
AgX100, I-125 Brachytherapy Seed
Theragenics Corporation, www.theragenics.com 
 Conditional 8

1.5, 3 

  Miscellaneous Implants and Devices 
Arto Implant
MVRx, Inc., www.mvrxinc.com 
 Conditional 8

1.5, 3 

  Miscellaneous Implants and Devices 
Atrial Flow Regulator, AFR

Occlutech, www.occlutech.com 
 Conditional 8

1.5, 3 

  Miscellaneous Implants and Devices 
Cardioband Mitral Reconstruction System Implant
Valtech Cardio Ltd., www.valtechcardio.com 
 Conditional 8

1.5, 3 

  Miscellaneous Implants and Devices 
IMPEDE Embolization Plug Device Shape Memory Medical Inc., www.shapemem.com    Conditional 8

1.5, 3 

  Miscellaneous Implants and Devices 
EluNIR Stent
Medinol Ltd., www.medinol.com 
 Conditional 8

1.5, 3 

  Coils, Filters, Stents, and Grafts 
L-Chord
Corpus Medical, Inc., www.corpusmed.com 
 Conditional 8

1.5, 3 

  Miscellaneous Implants and Devices 
LINTRAK C, RFID Tag
Invengo Technologies, www.invengo.com 
 Conditional 8

1.5, 3 

  Miscellaneous Implants and Devices 
PortIO, Intraosseous Infusion Device
PAVmed, Inc., www.pavm.com 
 Conditional 8

1.5, 3 

  Miscellaneous Implants and Devices 
T12 Tack, Tack Endovascular System
Intact Vascular, Inc., www.intactvascular.com 
 Conditional 8

1.5, 3 

  Miscellaneous Implants and Devices 
TheraSeed, Model 200 Pd-103, Brachytherapy Seed
Theragenics Corporation, www.theragenics.com 
 Conditional 8

1.5, 3 

  Miscellaneous Implants and Devices 
Universal Cylinder Family Sets
Universal Cylinder Applicator with Cervix Probe
Varian Medical Systems, www.varian.com 
 Conditional 8

1.5, 3 

  Miscellaneous Implants and Devices 
ON-Q EchoSpark, Echogenic Non-Stimulating Catheter
Halyard Health, www.halyardhealth.com 
 Conditional 8

1.5, 3 

  Miscellaneous Implants and Devices 
Lacriflow Lacrimal Duct Tube
Kaneka Corporation, www.kaneka-eye.com 
 Conditional 8

1.5, 3 

  Ocular Implants, Lens Implants, and Devices 
Malhotra Platinum Segment
Altomed Limited, www.altomed.com 
 Conditional 8

1.5, 3 

  Ocular Implants, Lens Implants, and Devices 
SOLX Gold Shunt
SOLX, Inc, www.solx.com 
 Conditional 8

1.5, 3 

  Ocular Implants, Lens Implants, and Devices 
Anterior Cervical Body Interbody Spacer (ACIS)
All versions
Depuy Synthes, www.depuysynthes.com 
 Conditional 8

1.5, 3 

  Orthopedic Implants, Materials, and Devices 

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