Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·AED 3 Defibrillator with Uni-Padz

NOVATHERM

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

PULSE GENERATOR 689, 689B & 689L

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODEL 430-07 ENDOCARDIAL PACING LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

ELC 35-UP MODEL NUMBER 116015 AND ELC 54-UP MODEL NUMBER 115606

FDA 510(k)

FDA Class 3 ·Cardiovascular

BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION AND PASSIVE FIXATION

FDA 510(k)

FDA Class 3 ·Cardiovascular

UNIPOLAR & BIOPLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION & PASSIVE FIXATION

FDA 510(k)

FDA Class 3 ·Cardiovascular

MEDTRONIS(R) PACING LEADS AND LEAD ADAPTORS, MODIF

FDA 510(k)

FDA Class 3 ·Cardiovascular

OSCOR PERMANENT RETRACTABLE SCREW-IN PACING LEAD MODEL PR

FDA 510(k)

FDA Class 3 ·Cardiovascular

TIR/TIJ AND POLYROX

FDA 510(k)

FDA Class 3 ·Cardiovascular

STELA MODEL BJ44 AND BJ45 PACING LEADS

FDA 510(k)

FDA Class 3 ·Cardiovascular

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·VNS THERAPY PERENNIAFLEX

OSCOR MEDICAL IMPLANTABLE PACING LEAD, RETRACTABLE

FDA 510(k)

FDA Class 3 ·Cardiovascular

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SYNCHROMED II IMPLANTABLE INFUSION SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·OCUFILCON D SPHERICAL AND TORIC EXTENDED WEAR CONTACT LENSES

PNEUMOTHORAX KIT, MOTIFICATION

FDA 510(k)

FDA Class 3 ·Orthopedic

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS ONE-PIECE INTRAOCULAR LENS, MODEL ZCB00

Ligaments And Tendons, Synthetic

FDA Pre-Market Approval

FDA Class 3 ·KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE

Ligaments And Tendons, Synthetic

FDA Pre-Market Approval

FDA Class 3 ·CENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE

Ligaments And Tendons, Synthetic

FDA Pre-Market Approval

FDA Class 3 ·STRKYER KNEE AUGMENTATION GRAFT