BIO-PEN CALCULATOR

FDA 510(k)

FDA Class 3 ·Unknown

Stimulator, Carotid Sinus Nerve

FDA Pre-Market Approval

FDA Class 3 ·BAROSTIM NEO Implantable Pulse Generator (IPG), BAROSTIM NEO Carotid Sinus Lead (CSL) Kit, Programmer System, Carotid Si

Stimulator, Carotid Sinus Nerve

FDA Pre-Market Approval

FDA Class 3 ·BAROSTIM NEO Implantable Pulse Generator (IPG), BAROSTIM NEO Carotid Sinus Lead (CSL) Kit, Programmer System, Carotid Le

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

FDA Pre-Market Approval

FDA Class 3 ·BIO-RAD MONOLISA ANTI-HBC IGM EIA

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval

FDA Class 3 ·PSW 2202.U and NEO 2202.U

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

FDA Pre-Market Approval

FDA Class 3 ·BIO-RAD MONOLISA ANTI-HBC IGM EIA

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·PSW 2100.U and NEO 2100.U

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PSW 2100.U and NEO 2100.U

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PSW 2100.U and NEO 2100.U

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

FDA Pre-Market Approval

FDA Class 3 ·BIO-RAD MONOLISA ANTI-HBC IGM EIA

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PSW 2100.U and NEO 2100.U

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·PSW 2100.U and NEO 2100.U

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

FDA Pre-Market Approval

FDA Class 3 ·BIO-RAD MONOLISA ANTI-HBC IGM EIA

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

FDA Pre-Market Approval

FDA Class 3 ·BIO-RAD MONOLISA ANTI-HBC IGM EIA

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

FDA Pre-Market Approval

FDA Class 3 ·MONOLISA ANTI-HBS EIA

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·Coseal Surgical Sealant

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·Coseal Surgical Sealant, Coseal Spray Set

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Stimulator, Spinal-Cord, Totally Implanted For Pain Relief; Class III; Prospera SCS System

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·COSEAL SURGICAL SEALANT

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·Coseal Surgical Sealant, Coseal Spray Set, Coseal Replacement Applicator, Coseal Extended Applicator