Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·AURORA MODELS 6291 & 6292 MULTIPROGRAM. DDD P. GEN

QMPLANTABLE PROGRAM. CARDIAC PULSE GEN. W/TELEMETR

FDA 510(k)

FDA Class 3 ·Cardiovascular

ALTERNATE PACKAGE CONFIG. FOR IMPLANT. PULSE GEN.

FDA 510(k)

FDA Class 3 ·Cardiovascular

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·S-ICD GEN 2 A209, S-ICD EMBLEM MRI A219

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE, IMMULITE 1000, IMMULITE 2000, and IMMULITE 2500 3rd gen PSA

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·S-ICD GEN 2, S-ICD EMBLEM, EMBLEM S-ICD ELECTRODE

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MODELS 940 & 941 VISTA DDD GEN. & MODEL 2050 MODUL

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Subcutaneous Implantable Defibrillator (S-ICD) EMBLEM MRI, S-ICD Gen 2.

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·ZIMMER NEXT GEN LPS -FLEX MOBILE AND LPS-MOBILE BEARING KNEE

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·NovaSure Impedance Controlled Endometrial Ablation System

CORATOMIC #VX5-105 & VX5-205 PULSE GEN.

FDA 510(k)

FDA Class 3 ·Cardiovascular

IMPLANTABLE PACEMAKER PULSE GEN, MODELS 241 & 242

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODEL 329D, SERIERS R BIOPOLAR CARDIAC PUL. GEN.

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODIFIED LABEL FOR/SPECTRAX SXT IMPLANT. PULSE GEN

FDA 510(k)

FDA Class 3 ·Cardiovascular

IMPLANTABLE PROGRAM-CARDIAC PULSE GEN-OPTIMA MP II

FDA 510(k)

FDA Class 3 ·Cardiovascular

Kit, Rna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·Aptima HPV Assay

Kit, Rna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·APTIMA HPV 16 18/45 GENOTYPE ASSAY

Prostrate Cancer Genes Nucleic Acid Amplification Test System

FDA Pre-Market Approval

FDA Class 3 ·PROGENSA PCA3 ASSAY

Kit, Rna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·APTIMA HPV ASSAY

Kit, Rna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·Aptima HPV Assay