Tissue Adhesive For Internal Use

FDA Pre-Market Approval

FDA Class 3 ·COHERA MEDICAL TISSUGLU SURGICAL ADHESIVE

Tissue Adhesive For Internal Use

FDA Pre-Market Approval

FDA Class 3 ·COHERA MEDICAL TISSUGLU SURGICAL ADHESIVE

Tissue Adhesive For Internal Use

FDA Pre-Market Approval

FDA Class 3 ·COHERA MEDICAL TISSUGLU

Tissue Adhesive For Internal Use

FDA Pre-Market Approval

FDA Class 3 ·COHERA MEDICAL TISSUGLU SURGICAL ADHESIVE

Tissue Adhesive For Internal Use

FDA Pre-Market Approval

FDA Class 3 ·COHERA MEDICAL TISSUEGLU SURGICAL ADHESIVE

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·QUIK-PAK Electrodes

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·QUIK-PAK™ Electrodes

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·QUIK-PAK Electrodes

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·samaritan® PAD 350P (SAM 350P), samaritan® PAD 360P (SAM 360P), samaritan® PAD 450P (SAM 450P), Pad-Paks (Adult, Pediatr

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·MOBILEXCIMER FOR PTK AND PRK

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·samaritan Public Access Automated External Defibrillators and Accessories

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P)

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P)

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·HeartSine samaritan® Public Access Automated External Defibrillators and Accessories

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·CLARION CII BIONIC EAR SYSTEM (ADULT)

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·CLARION CII BIONIC EAR SYSTEM (PEDIATRIC)

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·LASERVISION/VISX EXCIMER LASER FOR PRK AND PTK (MOBILEXCIMER)

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PAK/CALIBRATOR

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Perceval PLUS Sutureless Heart Valve

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·BIOLECTRON ORTHO-PAK BONE GROWTH STIMULATOR/SPINALPAK SPINAL FUSION STIMULATOR