Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·PD-L1 IHC 22C3 pharmDx

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·CEEON HEPARIN SURFACE MODIFIED (HSM) UV LIGHT-ABSORBING POSTERIOR CHAMBER IOLS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·CEEON HSM UV LIGHT ABSORBING PMMA ANTERIOR CHAMBER IOLS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·CEEON MODELS 911A AND 913A, TECNIS MODELS Z9000 AND Z9001

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·ANIMAS VIBE SYSTEM

Mr-Guided Focused Ultrasound System

FDA Pre-Market Approval

FDA Class 3 ·Exablate 4000 System

Implanted Diaphragmatic/Phrenic Nerve Stimulator

FDA Pre-Market Approval

FDA Class 3 ·DIAPHRAGMATIC PACEMAKER PHRENIC NERVE STIMULATOR

Implanted Diaphragmatic/Phrenic Nerve Stimulator

FDA Pre-Market Approval

FDA Class 3 ·DIAPHRAGMATIC PACEMAKER PHRENIC NERVE STIMULATOR

Implanted Diaphragmatic/Phrenic Nerve Stimulator

FDA Pre-Market Approval

FDA Class 3 ·DIAPHRAGMATIC PACEMAKER PHRENIC NERVE STIMULATOR

Implanted Diaphragmatic/Phrenic Nerve Stimulator

FDA Pre-Market Approval

FDA Class 3 ·DIAPHAGMATIC/PHRENIC NERVE STIMULATOR

Implanted Diaphragmatic/Phrenic Nerve Stimulator

FDA Pre-Market Approval

FDA Class 3 ·DIAPHRAGMATIC PACEMAKER PHRENIC NERVE STIMULATOR

Implanted Diaphragmatic/Phrenic Nerve Stimulator

FDA Pre-Market Approval

FDA Class 3 ·DIAPHRAGMATIC PACEMAKER PHRENIC NERVE

Implanted Diaphragmatic/Phrenic Nerve Stimulator

FDA Pre-Market Approval

FDA Class 3 ·DIAPHRAGMATIC PACEMAKER PHRENIC NERVE STIMULATOR

Implanted Diaphragmatic/Phrenic Nerve Stimulator

FDA Pre-Market Approval

FDA Class 3 ·DIAPHRAGMATIC PACEMAKER PHRENIC NERVE STIMULATOR

Implanted Diaphragmatic/Phrenic Nerve Stimulator

FDA Pre-Market Approval

FDA Class 3 ·Avery Diaphragm Pacing System (alson known as Breathing Pacemaker System)

Implanted Diaphragmatic/Phrenic Nerve Stimulator

FDA Pre-Market Approval

FDA Class 3 ·DIAPHRAGMATIC PACEMAKER PHRENIC NERVE STIMULATOR

Oximeter, Fetal Pulse

FDA Pre-Market Approval

FDA Class 3 ·COROMETRICS MODEL 120 SERIES MATERNAL/FETAL MONITOR W/INTEGRATED FETAL PULSE OXIMETRY

Stimulator, Fetal, Acoustic

FDA Pre-Market Approval

FDA Class 3 ·COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·PD-L1 IHC 22C3 pharmDx

Automated Breast Ultrasound

FDA Pre-Market Approval

FDA Class 3 ·Invenia ABUS Autoated Breast Ultrasound System