Sensatronic Reusable Temperature Probes

FDA 510(k)

FDA Class 2 ·General Hospital

Breast BI 7 MR Coil 1.5T Mammavention

FDA 510(k)

FDA Class 2 ·Radiology

Breast BI 7 MR Coil Mammavention 3T

FDA 510(k)

FDA Class 2 ·Radiology

Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3T

FDA 510(k)

FDA Class 2 ·Radiology

DIAGNOSOFT HARP

FDA 510(k)

FDA Class 2 ·Radiology

FILMSAVER, NT VERSION 5.03

FDA 510(k)

FDA Class 2 ·Radiology

FLASH AR PENTA / FLASH AR PENTA QUICK

FDA 510(k)

FDA Class 2 ·Dental

ECO-RX AIR PURIFIER WITH UV LIGHT, MODEL RX-400

FDA 510(k)

FDA Class 2 ·General Hospital

Visualase V2 MRI-guided Laser Ablation System (9736422)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Visualase MRI-Guided Laser Ablation System (SW 3.4)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Monteris Medical NeuroBlate System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TRANBERG Thermoguide Therapy System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ALLURA 3D-RA REL 6, 3D ROADMAP REL 1, MR-CT ROADMAP REL 1

FDA 510(k)

FDA Class 2 ·Radiology

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT AXSYM/TOTAL PSA

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PTCA CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCHNEIDER PTCA CATHETERS

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·RAY TFC UNITE PRODUCT LINE

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·RAY THREADED FUSION CAGE(TFC)

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·BOSTON SCIENTIFIC MAVERICK 2 PTCA CATHETER