VERTEX ETCHANT

FDA 510(k)

FDA Class 2 ·Dental

SENSATIONS BRAND CONDOMS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

RHEA CUP

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

BGM009 Plus Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VERTEX SEALAND L/C ORTHODONTIC SEALANT

FDA 510(k)

FDA Class 2 ·Dental

INTERFACE

FDA 510(k)

FDA Class 2 ·Dental

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·NC QUANTUM APEX MONORAIL AND OVER-THE-WIRE PTCA CATHETERS

SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit

FDA 510(k)

FDA Class 2 ·Neurology

Sprint System, Single Procedure Kit, Sprint System with Pad II, Single Procedure Kit, Sprint System, Multi-Procedure Kit, Sprint System, Sterile Components Kit, Sprint System, Stimulator Kit

FDA 510(k)

FDA Class 2 ·Neurology

First Relief

FDA 510(k)

FDA Class 2 ·Neurology

Primary Relief

FDA 510(k)

FDA Class 2 ·Neurology

SPRINT Peripheral Nerve Stimulation (PNS) System

FDA 510(k)

FDA Class 2 ·Neurology

VERTIS PNT CONTROL UNIT, MODEL CU 100; VERTIS PNT SAFEGUIDE-CERVICAL, MODEL SG 102-XXX

FDA 510(k)

FDA Class 2 ·Neurology

DEEPWAVE PERCUTANEOUS NEUROMODULATION PAIN THERAPY SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

Primary Relief

FDA 510(k)

FDA Class 2 ·Neurology

VERTIS PNT CONTROL UNIT, VERTIS PNT SAFEGUIDE KIDS, MODELS CU100, SGXXX

FDA 510(k)

FDA Class 2 ·Neurology

SPRINT PNS System

FDA 510(k)

FDA Class 2 ·Neurology

ANSiStim-PP

FDA 510(k)

FDA Class 2 ·Neurology

Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs

FDA 510(k)

FDA Class 2 ·Neurology

SPRINT PNS System

FDA 510(k)

FDA Class 2 ·Neurology