POLY INSERT 20 DEGREE

FDA 510(k)

FDA Class 3 ·Orthopedic

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·HiResolution Bionic Ear System/AIM System

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·NIDEK EC-5000 EXCIMER LASER SYSTEM

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·HiResolution Bionic Ear System

Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep

FDA Pre-Market Approval

FDA Class 3 ·EXOGEN BONE HEALING SYSTEM 2000 ,3000

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADAPTA,VERSA,SENSIA,ADVISA DR IPG,ADVISA DR MRI IPG,RELIA IPG

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MAXIMOII ICD

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·CONSULTA CRT-P, SYNCRA CRT-P

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RENO MRI IPG

Catheter, Sampling, Chorionic Villus

FDA Pre-Market Approval

FDA Class 3 ·TROPHOCAN TM CHORIONIC VILLUS SAMPLING CATHETER

Catheter, Sampling, Chorionic Villus

FDA Pre-Market Approval

FDA Class 3 ·TROPHOCAN TM

Catheter, Sampling, Chorionic Villus

FDA Pre-Market Approval

FDA Class 3 ·TROPHOCAN TM CHORIONIC VILLUS SAMPLING CATHETER

Catheter, Sampling, Chorionic Villus

FDA Pre-Market Approval

FDA Class 3 ·TROPHOCAN TM

Catheter, Sampling, Chorionic Villus

FDA Pre-Market Approval

FDA Class 3 ·TROPHOCAN TM CHORIONIC VILLUS SAMPLING CATHETER

Catheter, Sampling, Chorionic Villus

FDA Pre-Market Approval

FDA Class 3 ·TROPHOCAN TM CHORIONIC VILLUS SAMPLING CATHETER

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Precision Spectra Spinal Cord Stimulator (SCS) System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Precision Montage MRI Spinal Cord Stimulator System

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·ISOMED REFILL KIT/BULK REFILL KIT/ISOMED CAP KIT

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LEAD END CAP KIT/ LEAD ADAPTOR SLEEVE KIT/UPSIZING SLEEVE KIT

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LEAD END CAP KIT / LEAD ADAPTOR SLEEVE KIT / UPSIZING SLEEVE KIT