Joint, Temporomandibular, Implant

FDA Pre-Market Approval

FDA Class 3 ·PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS SYSTEM

Joint, Temporomandibular, Implant

FDA Pre-Market Approval

FDA Class 3 ·Patient-Fitted TMJ Reconstruction Prosthesis System

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM

Joint, Temporomandibular, Implant

FDA Pre-Market Approval

FDA Class 3 ·TMJ FOSSA-EMINENCE/CONDYLAR PROSTHESIS SYSTEM AND TMJ FOSSA-EMINENCE PROSTHESIS

Glenoid Fossa Prosthesis

FDA Pre-Market Approval

FDA Class 3 ·TMJ FOSSA-EMINENCE/CONDYLAR PROSTHESIS SYSTEM AND TMJ FOSSA-EMINENCE PROSTHESIS

System, Hemodynamic, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CardioMEMS HF System

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·MODEL 8005 PUMP SYSTEM (CIRCUCOOL PUMP), MODEL M00480050

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators and Accessories

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG

Glenoid Fossa Prosthesis

FDA Pre-Market Approval

FDA Class 3 ·TMJ FOSSA-EMINENCE PROSTHESIS SYSTEM

Glenoid Fossa Prosthesis

FDA Pre-Market Approval

FDA Class 3 ·TMJ FOSSA-EMINENCE PROSTHESIS SYSTEM

Glenoid Fossa Prosthesis

FDA Pre-Market Approval

FDA Class 3 ·TMJ FOSSA-EMINENCE PROSTHESIS SYSTEM

Glenoid Fossa Prosthesis

FDA Pre-Market Approval

FDA Class 3 ·TMJ FOSSA-EMINENCE PROSTHESIS(TM)

Glenoid Fossa Prosthesis

FDA Pre-Market Approval

FDA Class 3 ·TMJ FOSSA-EMINENCE PROSTHESIS SYSTEM

Joint, Temporomandibular, Implant

FDA Pre-Market Approval

FDA Class 3 ·TMJ FOSSA-EMINENCE/CONDYLAR PROSTHESES