Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·GORE CARDIOFORM Septal Occluder

Automated Breast Ultrasound

FDA Pre-Market Approval

FDA Class 3 ·SOMO-V AUTOMATED BREAST ULTRASOUND SYSTEM

FDA Pre-Market Approval

HOME ACCESS HEPATITIS C CHECK AND HEPATITIS C CHECK EXPRESS

No. V1 097447 0006

Certificate

IVDD Annex IV (excluding sections 4, 6)·HMD Biomedical Inc.·TÜV SÜD Product Service GmbH·22 Basic UDI-DIs

No. V1 097447 0006

Certificate

IVDD Annex IV (excluding sections 4, 6)·HMD Biomedical Inc.·TÜV SÜD Product Service GmbH·6 Basic UDI-DIs

No. V1 097447 0006

Certificate

IVDD Annex IV (excluding sections 4, 6)·HMD Biomedical Inc.·TÜV SÜD Product Service GmbH·1 Basic UDI-DI

LEONE SPA

FDA UDI

LEONE SPA·08033707071600·MINI ORTHODONTIC IMPLANT KIT W/GROOVE

LEONE SPA

FDA UDI

LEONE SPA·08033707071594·KIT MINI ORTHODONTIC IMPLANTS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK PRIZM AVT AICD SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VITALITY AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEMS AND MODEL 2857 SOFTWARE, VERSION 1.6

Implantable Cardioverter Defibrillator (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/

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

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