Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·KREMER LASER SYSTEM

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT IMX FREE PSA

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·LADARVISION 4000 EXCIMER LASER SYSTEM

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval

FDA Class 3 ·PyloPlus® UBT System

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg

FDA Pre-Market Approval

FDA Class 3 ·LIAISON Biotrin Parvovirus B19 IgG Plus, LIAISON Biotrin Control Parvovirus B19 IgG Plus

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·HIRESOLUTION BIONIC EAR SYSTEM

Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

FDA Pre-Market Approval

FDA Class 3 ·FreeStyle Libre 14 Day Flash Glucose Monitoring System

Antigen(Complexed),Prostate Specific,(Cpsa)

FDA Pre-Market Approval

FDA Class 3 ·BAYER IMMUNO 1 COMPLEXED PSA ASSAY

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·INTELLATIP MIFI XP- ABLATION CATHETER AND BLAZER PRIME XP CATHETER

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

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·MEMORYGEL SILICONE GEL -FILLED BREAST IMPLANTS

Antigen(Complexed),Prostate Specific,(Cpsa)

FDA Pre-Market Approval

FDA Class 3 ·BAYER ACS:180 OR ADVIA CENTAUR COMPLEX PSA ASSAYS

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MINIMED 530G SYSTEM

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·HeartStart FRx Defibrillator

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·STAR S4 ACTIVETRAK EXCIMER LASER SYSTEM AND WAVESCAN WAVEFRONT SYSTEM

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·VISX EXCIMER LASER SYSTEM MODEL C STAR

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·VISX STAR EXCIMER LASER SYSTEM

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·NIDEK EC-5000 EXCIMER LASER SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·THERMOCOOL SMARTTOUCH SF UNI-DIRECTIONAL NAVIGATION CATHETER; THERMOCOOL SMARTTOUCH SF BI-DIRECTIONAL NAVIGATION CATHETE

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

FDA Pre-Market Approval

FDA Class 3 ·ACCESS HYBRITECH PSA WHO STANDARDIZATION