Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Menicon Z (tisilfocon) Rigid Gas Permeable Contact Lens and Menicon Z Night (tisilfocon A) Contact Lenses for Overnight

Digital Breast Tomosynthesis

FDA Pre-Market Approval

FDA Class 3 ·Selenia Dimensions / 3Dimensions

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BAUSCH AND LOMB POLYMACON CONTACT LENSES

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·TSLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·RESTORE, RESTOREPRIME, RESTOREADVANCED, RESTORE PRIME ADVANCED, AND RESTOREULTRA NEUROSTIMULATION SYSTEMS

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC(R) SYNCHROMED II WELDING PROCESSES MONITORS AND CONTROLS

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·RESTORE,ITREL AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES,SPECIFY,AND VECTRIS SPINAL CORD STIMULATION LEADS

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Biofinity Sphere and Biofinity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·LCS TOTAL KNEE SYSTEM

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Precision Spinal Cord Stimulator (SCS) Systems -Precision Spectra, Spectra WaveWriter, Precision Novi, Precision Montage

MYRIAN

FDA UDI

INTRASENSE·03700719700440·Software medical device aimed at reviewing imag...

IMAGEGRID RADIOLOGY VIEWER SYSTEM

FDA UDI

CANDELIS, INC.·B193IGUHPR1HR0·The ImageGrid® PACS is a software system intend...

Merge Cardio

FDA UDI

MERGE HEALTHCARE SOLUTIONS INC.·00842000100041·Standalone software application.

ClearRead Enhanced Docker

FDA UDI

Riverain Technologies, Inc.·M722XD21012E203200·ClearRead Enhanced on Docker Platform

OpenSight

FDA UDI

Novarad Corporation·B109OPENSIGHT187060·OpenSight is the combination of augmented reali...

IMAGEGRID RADIOLOGY VIEWER SYSTEM

FDA UDI

CANDELIS, INC.·B193IG4H0·ImageGrid Radiology Viewer System is a device t...

syngo Dynamics VA20G Packaging Label

FDA UDI

Siemens Healthcare GmbH·04056869247175·

MR Diffusion Perfusion Mismatch

FDA UDI

Olea Medical USA·EOLEMRDPMV1P00·MR Diffusion Perfusion Mismatch V1.0 is an auto...