ACTH IRMA KIT II MITSUBISHI YUKA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FIRST CHECK HOME DRUG TEST PANEL 4

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

VERAVIEWEPOCS

FDA 510(k)

FDA Class 2 ·Dental

THE BIOPLATE MANDIBLE FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

CORSAIRE

FDA 510(k)

FDA Class 2 ·Physical Medicine

MEDICOM, TENS ELECTRODES

FDA 510(k)

FDA Class 2 ·Neurology

FACE TANNER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SUN TANNING BED

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OSTEO CT FOR THE SOMATOM AR FAMILY AND PLUS 4 CT SYSTEMS

FDA 510(k)

FDA Class 2 ·Radiology

PES HOT/COLD COMPRESS

FDA 510(k)

FDA Class 2 ·Physical Medicine

SOFTLIGHT Q-SWITCHED ND: YAG LASER WITH OPTIONAL BEAM-SHRINKING HANDPIECE ACCESSORY

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BOVINE PERICARDIUM PATCH

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CARESTART CARDIAC 3-IN-1 TROPONIN 1/CK-MB/MYOGLOBIN

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·D114S/NEPTUNE X-ACT OVER-THE-WIRE BALLOON DILATATION CATHETER

Flosteril Poly-reinforced Isolation Gowns Model 8120 (Catalogue Number 8120400), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120410), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120430), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120450), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120460)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·NEPTUNE X-ACT OVER-THE-WIRE BALLOON DILATATION ACATHETER WITH HYDRO/PEL COATING AND ANTI BACK BLEED DEVICE

EZ SMART-168 GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LEESPEC DISPOSABLE VAGINAL SPECULUM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SAMPLOK LUER KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10

FDA 510(k)

FDA Class 2 ·Clinical Chemistry