Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK PRIZM 2 VR/DR MODELS 1860/1861; VENTAK PRIZM VR/DR MODELS 1850/1851/1855/1856; VENTAK PRIZM VR/DR HE MODELS 1852

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·BRANTIGEN I/F CAGE(R) USED WITH VSP(R) SPINE PLATES AND PEDICLE SCREWS

Dark Star Deformity Pedicle Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

Dark Star Navigation Instrument System

FDA 510(k)

FDA Class 2 ·Neurology

GRIND GUARD

FDA 510(k)

FDA Unclassified ·Unknown

GRIND GUARD

FDA 510(k)

FDA Unclassified ·Unknown

Wiselink Medical (Ireland) Limited

Authorized representative

🇮🇪 Ireland·5 Manufacturers·25 Devices

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VITALITY 2 AICD SYSTEM (MODELS T165, T167, T175, T177), MODEL 2857 APPLICATION SOFTWARE (VERSION 2.2) AND QUICK PROFILE

Curaplex

FDA UDI

BOUND TREE MEDICAL, LLC·00815277021524·Curaplex Wall Mount PPE Kit

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·INTER FIX RP THREADED FUSION DEVICE-REDUCED PROFILE

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADVISA SR MRI

System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA Pre-Market Approval

FDA Class 3 ·ONCOR(R) AMPLITECT(TM) HER/NEU(ERBB2)GENE AMPLIFI

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VITALITY AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEMS

Spinal Pedicle Screw, Fixation, Appliance System

FDA Pre-Market Approval

FDA Class 3 ·SABER LUMBAR I/F CAGE, JAGUAR LUMBAR I/F CAGE

Suction Control, Intracardiac, Cardiopulmonary Bypass

FDA classification

FDA Class 2 ·Suction Control, Intracardiac, Cardiopulmonary Bypass

Protector, Hearing (Insert)

FDA classification

FDA Unclassified ·Protector, Hearing (Insert)

Stimulator, Autonomic Nerve, Implanted (Depression)

FDA classification

FDA Class 3 ·Stimulator, Autonomic Nerve, Implanted (Depression)

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·VISTA LORDOTIC INTERBODY FUSION CAGE

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VITALITY AVT AND THE PROGRAMMER SOFTWARE APPLICATION MODEL 2812

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE