NIDEK STEREO DISC CAMERA(3-DX)/NIDEK STEREO FUNDUS CAMERA(3-DXF)

FDA 510(k)

FDA Class 2 ·Ophthalmic

Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable

FDA 510(k)

FDA Class 2 ·Cardiovascular

Z-6 Atrioseptostomy Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F)

FDA 510(k)

FDA Class 2 ·Cardiovascular

ProTrack RF Anchor Wire

FDA 510(k)

FDA Class 2 ·Cardiovascular

Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

BLADE SEPTOSTOMY CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

HOTWIRE™ RF Guidewire

FDA 510(k)

FDA Class 2 ·Cardiovascular

PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS

FDA 510(k)

FDA Class 2 ·Cardiovascular

VersaCross™ RF Wire

FDA 510(k)

FDA Class 2 ·Cardiovascular

Park Blade Septostomy Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

NRG TRANSSEPTAL NEEDLE

FDA 510(k)

FDA Class 2 ·Cardiovascular

NUMED Z-5 ATRIOSEPTOSTOMY CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75

FDA 510(k)

FDA Class 2 ·Cardiovascular

BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE

FDA 510(k)

FDA Class 2 ·Cardiovascular

REGULATED PRESSURE INJECTOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Cross Wise™ Multi-Use RF Adapter Cable

FDA 510(k)

FDA Class 2 ·Cardiovascular

Catheter, Septostomy

FDA classification

FDA Class 2 ·Catheter, Septostomy

ACROSSPINE PEDICLE SCREW SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic