ISL QC 2000 LASER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ScandiDos Delta4 Phantom+

FDA 510(k)

FDA Class 2 ·Radiology

Delta4 Insight

FDA 510(k)

FDA Class 2 ·Radiology

SINGLE USE ESOPHAGEAL MANOMETEY CATHETERS AND SINGLE USE ANO-RECTAL MANOMETRY CATHETERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW)

FDA 510(k)

FDA Class 2 ·Radiology

DiviTum TKa

FDA 510(k)

FDA Class 2 ·Immunology

Plexus

FDA 510(k)

FDA Class 2 ·Cardiovascular

ROCATEC(R) -PLUS

FDA 510(k)

FDA Class 2 ·Dental

SONO(R) -CEM

FDA 510(k)

FDA Class 2 ·Dental

ESPE(R) -SIL

FDA 510(k)

FDA Class 2 ·Dental

BEBIG PLAQUES RUM101-RUM114

FDA 510(k)

FDA Class 2 ·Radiology

MS-39

FDA 510(k)

FDA Class 2 ·Ophthalmic

REOSS POWDER, REOSS PUTTY, REOSS GEL, MODELS R-1,RP-1, RG-1

FDA 510(k)

FDA Class 2 ·Orthopedic

Tek RMD (Tek Robotic Mobilization Device)

FDA 510(k)

FDA Class 2 ·Physical Medicine

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·Biosense Webster Cables, EZ Steer Nav Catheter, NaviStar Catheter, NaviStar RMT Catheter

Catheter, Flow Directed

FDA Pre-Market Approval

FDA Class 2 ·VOYAGER OTW CORONARY DILATION CATHETER

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·STOCKERT 70 RF GENERATOR AND ACCESSORIES/INTERFACE CABLE

Catheter, Flow Directed

FDA Pre-Market Approval

FDA Class 2 ·RX CHASSIS 3 CORONARY DILATATION CATHETER

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·NAVISTAR RMT; NAVISTAR RMT DS CATHETER

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·EZ Steer Nav Catheter, NaviStar Catheter, NaviStar RMT Catheter, and Biosense Webster Cables