Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GUARDIAN(R) ATP II IMPLANTABLE CARDIOVERTER/DIFIB.

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY Anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody

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

FDA Pre-Market Approval

FDA Class 3 ·FPSA FLEX REAGENT CARTRIDGE

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody

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

FDA Pre-Market Approval

FDA Class 3 ·DIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RES-Q(TM) ARRHYTHMIA CONTROL DEVICE EPICARDIAL PATCH AND NON-THORACOTOMY LEAD (NTL) SYSTEMS

Processor, Cervical Cytology Slide, Automated

FDA classification

FDA Class 3 ·Processor, Cervical Cytology Slide, Automated

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA classification

FDA Class 3 ·Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·SONATATI100 COCHLEAR IMPLANT

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·VENTANA PD-L1(SP142) Assay.

Optoacoustic Imaging System

FDA Pre-Market Approval

FDA Class 3 ·Imagio® Breast Imaging system

Optoacoustic Imaging System

FDA Pre-Market Approval

FDA Class 3 ·Imagio Breast Imaging System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·SONATA TI 100 COCHLEAR IMPLANT

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·PARADIGM REAL-TIME SYSTEM AND GUARDIAN REAL-TIME SYSTEM

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·COMBI 40+ COCHLEAR IMPLANT SYSTEM

System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection

FDA classification

FDA Class 3 ·System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection

Immunohistochemistry Antibody Assay, C-Kit

FDA classification

FDA Class 3 ·Immunohistochemistry Antibody Assay, C-Kit

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·BD Onclarity™ HPV Assay

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·BD Onclarity HPV Assay