Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·Anchoring Sleev Kit and SelectSecure LEad

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·QIAGEN THERASCREEN EGFR RGQ PCR KIT

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·QIAGEN THERASCREEN KRAS RGQ PCR KIT

System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA Pre-Market Approval

FDA Class 3 ·PATHVYSION HER-2 DNA PROBE KIT

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·therascreen FGFR RGQ RT-PCR Kit

Joint, Temporomandibular, Implant

FDA Pre-Market Approval

FDA Class 3 ·Patient-Fitted TMJ Reconstruction Prosthesis System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·SCS Accessory and A127 Extension Kits

Dorsal Root Ganglion Stimulator For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·NextGen DRG Lead Kit and Accessories

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

FDA Pre-Market Approval

FDA Class 3 ·Alinity i Anti-HBs Reagent Kit

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·SMARTABLATE SYSTEM-SMARTABLATE IRRIGATION PUMP KIT

Stimulator, Low Electric Field, Tumor Treatment

FDA Pre-Market Approval

FDA Class 3 ·NOVOCURE LTD'S NOVOTTF-100A TREATMENT KIT

Joint, Temporomandibular, Implant

FDA Pre-Market Approval

FDA Class 3 ·PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS SYSTEM

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·therascreen® KRAS RGQ PCR Kit

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·GELFOAM (ABSORBABLE GELATIN) PLUS HEMOSTATIS KIT

System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA Pre-Market Approval

FDA Class 3 ·PATHVYSION HER-2 DNA PROBE KIT

System, Photopheresis, Extracorporeal

FDA Pre-Market Approval

FDA Class 3 ·THERAKOS CELLEX PHOTOPHERESIS SYSTEM PROCEDURAL KIT

Laparoscopic Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval

FDA Class 3 ·DISPOSABLE FALOPE-RING BAND APPLICATOR KITS

Joint, Temporomandibular, Implant

FDA Pre-Market Approval

FDA Class 3 ·Patient-Fitted TMJ Reconstruction Prosthesis System

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval

FDA Class 3 ·BREATHTEK UBT FOR H.PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA)

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·AEGEA VAPOR SYSTEM, AEGEA VAPOR PROBE PROCEDURE KIT, AEGEA VAPOR GENERATOR AND AEGEA VAPOR GENERATOR ACCESSORY KIT