Calibrator For Alpha-Fetoprotein In Mid-Pregnancy Maternal Serum

FDA Pre-Market Approval

FDA Class 3 ·AFP MID-PREGNANCY REFERENCE PREPARATION

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·BTE(BEHIND-THE-EAR)T-MIC

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·BTE(BEHIND-THE-EAR)T-MIC

Immunohistochemistry Assay, Antibody, Ki-67

FDA Pre-Market Approval

FDA Class 3 ·Ki-67 IHC MIB-1 pharmDx (Dako Omnis)

Immunohistochemistry Assay, Antibody, Ki-67

FDA Pre-Market Approval

FDA Class 3 ·Ki-67 IHC MIB-1 pharmDx (Dako Omnis)

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

FDA Class 3 ·CollaPlug Absorbable Collagen Wound Dressing For Dental Surgery

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·HIRESOLUTION BIONIC EAR SYSTEM, HIRES ULTRA COCHLEAR IMPLANT WITH THE HIFOCUS MID-SCALA ELECTRODE

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) FAMILY/FLOUR/SYRINGEAVITENE/CAST MICROFIBRILLAR COLLAGEN HEMOSTAT(MCH)

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·Cerene Cryotherapy Device (Model Number FGS-7000)

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·CONTINUOUS GLUCOSE MONITORING SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Accolade Non-MRI Pacemakers: ALTRUA 2, ESSENTIO, PROPONENT and ACCOLADE

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·NG3 Cardiac Resynchronization Therapy-Defibrillator (CRT-D) Devices: AUTOGEN, DYNAGEN, INOGEN and ORIGEN; NG4 CRT-D Devi

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Accolade MRI Pacemakers: ESSENTIO MRI, PROPONENT MRI and ACCOLADE MRI

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

FDA Pre-Market Approval

FDA Class 3 ·sentus QP LV Lead

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Algovita Spinal Cord Stimulation System

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·EP Passion Initiative

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

FDA Pre-Market Approval

FDA Class 3 ·Accolade Cardiac Resynchronization Therapy-Pacemaker (CRT-P) Devices: VALITUDE, VALITUDE, and VISIONIST

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·NG3 Implantable Cardiac Defibrillators (ICDs): AUTOGEN, DYNAGEN, INOGEN and ORIGEN; NG4 ICDs: MOMENTUM, VIGILANT, PERCIV

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·STINGER/STRINGER S/STINGER M/STINGER SM/SCORPION/SCORPION M/SCORPION *2/SCORPION *2 M ABLATION CATHETERS

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM