System, Esophageal Pacing

FDA Pre-Market Approval

FDA Class 3 ·ARZCO OCTAPOLAR ESOPHAGEAL CARDIAC STIMULATORS

System, Esophageal Pacing

FDA Pre-Market Approval

FDA Class 3 ·STAT-PACE II ESOPHAGEAL PACING SYSTEM

System, Esophageal Pacing

FDA Pre-Market Approval

FDA Class 3 ·TAP SYSTEM 2A

System, Esophageal Pacing

FDA Pre-Market Approval

FDA Class 3 ·TAPSYSTEM 2A

Device, Testicular Hypothermia

FDA Pre-Market Approval

FDA Class 3 ·REPRO-MED - THD

Device, Testicular Hypothermia

FDA Pre-Market Approval

FDA Class 3 ·REPRO-MED - THD

System, Esophageal Pacing

FDA Pre-Market Approval

FDA Class 3 ·ESOPHAGEAL CARDIAC RECORDING & PACING CATHETER

Device, Testicular Hypothermia

FDA Pre-Market Approval

FDA Class 3 ·REPRO-MED - THD

System, Esophageal Pacing

FDA Pre-Market Approval

FDA Class 3 ·EXTERNAL PULSE GENERATOR MODEL 2A, TAPSCOPE 500 SERIES ESOPHAGEAL STETHOSCOPE AND PACING CATHETER, TAPSCOPE 210 ESOPHAGR

System, Esophageal Pacing

FDA Pre-Market Approval

FDA Class 3 ·ARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR MODEL 7

System, Esophageal Pacing

FDA Pre-Market Approval

FDA Class 3 ·TAPCATH AND TAPSCOPE DISPOSABLE TRANSESOPHAGEAL PROBES

Device, Testicular Hypothermia

FDA Pre-Market Approval

FDA Class 3 ·REPRO-MED - THD

System, Esophageal Pacing

FDA Pre-Market Approval

FDA Class 3 ·ARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR MODEL 7

System, Appendage Closure, Left Atrial

FDA Pre-Market Approval

FDA Class 3 ·WATCHMAN FLX Left Atrial Appendage (LAA) Closure Technology, WATCHMAN FLX Left Atrial Appendage Closure Device with Deli

System, Appendage Closure, Left Atrial

FDA Pre-Market Approval

FDA Class 3 ·WATCHMAN FLX™ Left Atrial Appendage Closure Device with Delivery System, WATCHMAN Left Atrial Appendage (LAA) Closure Te

System, Appendage Closure, Left Atrial

FDA Pre-Market Approval

FDA Class 3 ·WATCHMAN FLX Left Atrial Appendage (LAA) Closure Technology, WATCHMAN FLX Left Atrial Appendage Closure Device with Deli

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval

FDA Class 3 ·SEPRAFILM BIORESORBABLE MEMBRANE

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

FDA Pre-Market Approval

FDA Class 3 ·AXSYM FREE PSA & ARCHITECT FREE PSA

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

FDA Pre-Market Approval

FDA Class 3 ·AXSYM TOTAL PSA & ARCHITECT TOTAL PSA

Glue, Surgical, Arteries

FDA Pre-Market Approval

FDA Class 3 ·BIOGLUE SURGICAL ADHESIVE