HYDRAGEL IF, 6 IF, 12 IF PENTA KITS/HYDRAGEL IF, DOUBLE IF, 2 IF, & 4 IF KITS

FDA 510(k)

FDA Class 2 ·Immunology

I3RAD 125 I BRACHYTHERAPY SEED, MODEL I125-0401

FDA 510(k)

FDA Class 2 ·Radiology

LOBSTER AUTO-INJECTOR

FDA 510(k)

FDA Class 2 ·General Hospital

IMAGYN 125 I SEED, MODEL IS 125

FDA 510(k)

FDA Class 2 ·Radiology

WHISPERJECT AUTOINJECTOR

FDA 510(k)

FDA Class 2 ·General Hospital

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·SGP II - F CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·SGP II - F CONTACT LENS

Diode laser hair removal device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ACROSSPINE PEDICLE SCREW SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Pulse Oximeter, Models PC-66A; PC-66B; PC-66C;PC-60B1; PC-60B5; PC-60D; PC-60D2; PC-60E; PC-60N; POD-1; POD-2; POD-3; PC-68A; PC-68B; PC-68C; POD- 1W; and POD-60NW-1

FDA 510(k)

FDA Class 2 ·Cardiovascular

CAROTID COIL 5000004901

FDA 510(k)

FDA Class 2 ·Radiology

MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Heel Incision Safety Lancet

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

JTK Dental Implant System

FDA 510(k)

FDA Class 2 ·Dental

VALUMAX SURGICAL MASKS (BLUE, PINK, GREEN, YELLOW, WHITE AND PEACH) WITH OR WITHOUT VISORS, TIES AND EARLOOPS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MAGLUMI 2000 FT4

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Anchor Dual Lumen Guidewire Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

PEDIATRIC HEAD-SPINE COIL (MODEL:5000012701

FDA 510(k)

FDA Class 2 ·Radiology

MAGLUMI 2000 25-OH Vitamin D

FDA 510(k)

FDA Class 2 ·Clinical Chemistry