1,132 results · 23ms · Sources: EU EUDAMED, US FDA

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval
FDA Class 2 ·BAK/C VISTA CERVICAL INTERBODY FUSION DEVICE

Accessories, Soft Lens Products

FDA Pre-Market Approval
FDA Class 2 ·APPLIED LABORATORIES STERILE SALINE SOLUTION

Accessories, Soft Lens Products

FDA Pre-Market Approval
FDA Class 2 ·APPLIED LABORATORIES STERILE SALINE SOLUTION

Pulse-Generator, Pacemaker, External

FDA Pre-Market Approval
FDA Class 2 ·BEDSIDE(TM) SINGLE CHAMBER, TXTERNAL PULSE GENERATOR, MODEL 4170

Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

FDA Pre-Market Approval
FDA Class 2 ·MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT AXSYM ANTIBODY TO HCV (ANTI-HCV)

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT AFP-EIA DIAGNOSTIC KIT FOR CANCER

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT AXSYM AFP

Accessories, Soft Lens Products

FDA Pre-Market Approval
FDA Class 2 ·BLAIREX STERILE SALINE SOLUTION

Accessories, Soft Lens Products

FDA Pre-Market Approval
FDA Class 2 ·BLAIREX STERILE SALINE SOLUTION

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·AXSYM ANTI-HCV

Accessories, Soft Lens Products

FDA Pre-Market Approval
FDA Class 2 ·BLAIREX STERILE SALINE SOLUTION

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·LACROSSE/WRAP*PTCA CATHETERS;CHAMPION NC/WRAP NC PTCA CATHETER PRODUCT LINES

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·PROGRESSIVE ANGTIOPLASTY SYSTEMS (PAS) CHAMPION PTCA CORONARY DILATATION CATHETER

Monitor, Carbon-Dioxide, Cutaneous

FDA Pre-Market Approval
FDA Class 2 ·TCO2M MODEL 818 MONITOR

Monitor, Carbon-Dioxide, Cutaneous

FDA Pre-Market Approval
FDA Class 2 ·TCO2M MODEL 818 MONITOR

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval
FDA Class 2 ·LITHO TRON LITHOTRIPSY SYSTEM

Monitor, Carbon-Dioxide, Cutaneous

FDA Pre-Market Approval
FDA Class 2 ·TCO2M MODEL 818 MONITOR

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval
FDA Class 2 ·HEALTHTRONICS LITHOTRON LIHTOTRIPSY SYSTEM

Monitor, Carbon-Dioxide, Cutaneous

FDA Pre-Market Approval
FDA Class 2 ·TCO2M MODEL 818 MONITOR