Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·NATRELLE 410 HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE-FILLED BREAST IMPLANTS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·BESTENT 2 WITH DISCRETE TECHNOLOGY OTW/RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·SCULPTRA AESTHETIC

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Clareon PanOptix Pro Trifocal Intraocular Lens (IOL), Clareon PanOptix Pro Trifocal Toric IOLs, Clareon PanOptix Pro Tr

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·STAARVISC II

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·HELISTAT,HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·IMPELLA LEFT VENTRICULAR SUPPORT SYSTEM

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval

FDA Class 3 ·PRAKTIS

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·IMPELLA VENTRICULAR SUPPORT SYSTEMS

Mr-Guided Focused Ultrasound System

FDA Pre-Market Approval

FDA Class 3 ·Exablate Neuro, Exablate Prime, Exablate Transcranial MRgFUS, Exablate Model 4000, Exablate Neuravive

P.F.C. APICAL PLUG

FDA 510(k)

FDA Class 3 ·Orthopedic

COOK PACEMAKER 332T, SERIES R BIPOLAR CARDIAC PULS

FDA 510(k)

FDA Class 3 ·Cardiovascular

COOK PACEMAKER CORP. 332T BIPOLAR CARDIAC PULSE GE

FDA 510(k)

FDA Class 3 ·Cardiovascular

COOK PACEMAKER 33IT R UNIPOLAR CARDIAC PULSE GENER

FDA 510(k)

FDA Class 3 ·Cardiovascular

JOINT MEASUREMENT INDICATOR

FDA 510(k)

FDA Class 3 ·Orthopedic

MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMER

FDA 510(k)

FDA Class 3 ·Cardiovascular

samaritan PAD 450P

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODEL 725TH HANDHELD TRANSCEIVER (PROGRAMMER)

FDA 510(k)

FDA Class 3 ·Cardiovascular

VISITHERM

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology