NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

Prostate-Specific Antigen (Psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers

FDA classification

FDA Class 2 ·Prostate-Specific Antigen (Psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers

Force Fiber OrthoTape suture

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BWM SPINE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

CWM-930S, FIXER DV9

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Retraction, CWM-910T, APOLEX Tite

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MEDART DIODE LASER SYSTEM & ACCESSORIES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OEM MULTI-VAC POWERED SUCTION PUMP

FDA 510(k)

FDA Class 2 ·General Hospital

ENERGIST ULTRAPLUS VARIABLE PULSED LIGHT (VPL) SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ENERGIST ULTRA VPL INTENSE PULSE LIGHT SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MEDART 620

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NeoGen PSR System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NEOGEN PSR SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AUTOMATES COMA PLUS COCAINE METABOLITE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

AUTOMATES COMA COCAINE METABOLITE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER D, DM, AND OEM-D (SOFTWARE VERSION 5.1)

Perfectio LED infrared device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·M-VU ALGORITHM ENGINE

BONE CEMENT FOR CRANIOPLASTY

FDA 510(k)

FDA Class 2 ·Neurology

ELEVARE, PERFECTIO 4

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery