GPC BONE PLAES AND BONE SCREW & GPC DHS/DCS PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Delta4 Insight

FDA 510(k)

FDA Class 2 ·Radiology

Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW)

FDA 510(k)

FDA Class 2 ·Radiology

DiviTum TKa

FDA 510(k)

FDA Class 2 ·Immunology

SCINTILLATION GAMMA CAMERA

FDA 510(k)

FDA Class 2 ·Radiology

QuantumCam

FDA 510(k)

FDA Class 2 ·Radiology

Plexus

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIASTAT ANTI-SM/RNP

FDA 510(k)

FDA Class 2 ·Immunology

DIASTAT ANTI-LA (SS-B)

FDA 510(k)

FDA Class 2 ·Immunology

DIASTAT ANTI-RO (SS-A)

FDA 510(k)

FDA Class 2 ·Immunology

DIASTAT ANTI-SM

FDA 510(k)

FDA Class 2 ·Immunology

DIASTAT ENA PROFILE

FDA 510(k)

FDA Class 2 ·Immunology

Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

FDA Pre-Market Approval

FDA Class 2 ·MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER

GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System

FDA 510(k)

FDA Class 2 ·Orthopedic

Catheter, Flow Directed

FDA Pre-Market Approval

FDA Class 2 ·VOYAGER OTW CORONARY DILATION CATHETER

Catheter, Flow Directed

FDA Pre-Market Approval

FDA Class 2 ·RX CHASSIS 3 CORONARY DILATATION CATHETER

Catheter, Flow Directed

FDA Pre-Market Approval

FDA Class 2 ·ESPRIT/CROSSAIL/OPENSAIL/POWERSAIL/HIGHSAIL CORONARY DILATION CATHETHERS

Catheter, Flow Directed

FDA Pre-Market Approval

FDA Class 2 ·HIGHSAIL CORONARY DILATATION CATHETERS

JJG EVOLUTION ORTHODONTIC IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

SWEDE-VENT ENDOSSEOUS HA COATED DENTAL IMPLANTS

FDA 510(k)

FDA Class 2 ·Dental