PACEMAKER, ANTRIO-VENTRICULAR SEQ.

FDA 510(k)

FDA Class 3 ·Cardiovascular

PULSE GENERATOR, A-V SEQ.

FDA 510(k)

FDA Class 3 ·Cardiovascular

Covered Stent Vascular Connector, Hemodialysis Access Circuit

FDA Pre-Market Approval

FDA Class 3 ·EndoForce™ Connector for Endovascular Venous Anastomosis

Covered Stent Vascular Connector, Hemodialysis Access Circuit

FDA Pre-Market Approval

FDA Class 3 ·EndoForce Connector for Endovascular Venous Anastomosis

Covered Stent Vascular Connector, Hemodialysis Access Circuit

FDA classification

FDA Class 3 ·Covered Stent Vascular Connector, Hemodialysis Access Circuit

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·SEN-SERTER

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LD SEN DF4 IB IR PF DC, LD SEN DF4 IB IR PF SC, LD SEN DF4 IB IR PF SC, LD SEN DF4 IB IR PF DC, LD SEN DF4 IB IR AF SC,

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·SEN-SERTER, MODEL: MMT-7500

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·9751A SYSTEM ENHANCEMENT MODULE (SEM)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·REL S, REL, REL SEZ, REL EZ DUAL COIL, REL SG, REL G, SEN

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DISPOSABLE COVER/EXTERNAL PULSE GENERATORS/CABLES/ADAPTOR/SURGICAL CABLE/PATIENT SAFETY CABLES/DISPOSABLE POUCH/SEM

Bone Grafting Material, Dental, With Biologic Component

FDA Pre-Market Approval

FDA Class 3 ·GEM 21S (GROWTH ENHANCED MATRIX)

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella RP System, Impella RP with SmartAssist System

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella 2.5 System, Impella CP System, Impella CP with SmartAssist System, Impella 5.0 System, Impella LD System,Impella

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA MRI ICD,EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT ICD,MAXIMO II ICD, PROTECTA ICD, PROTECT XT ICD,SEC

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI ICD, Evera S DR/ S VR ICD's; Evera XT DR ICD/ XT VR ICD; Maximo II ICD; Protecta VR/XT ICD; Secura DR ICD, Sec

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·SVS APEX APEX EXIMER LASER WORKSTATION

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval

FDA Class 3 ·PROSTATRON

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval

FDA Class 3 ·UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval

FDA Class 3 ·PROLIEVE THERMODILITATION SYSTEM