LABELING SUBMITTAL, ADX AMPHETAMINE/METHAMPHETA.II

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

REVISIED LABELING FOR ADX BENZODIAZEPINES

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

REVISED LABELING FOR ADX OPIATES

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

REVISED LABELING FOR ADX CANNABINOIDS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

KLS MARTIN 3DX EXTERNAL DISTRACTION SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

Sphere-9Dx Diagnostic Catheter (AFR-00009)

FDA 510(k)

FDA Class 2 ·Cardiovascular

LABELING SUBMITTAL, ADX TM CANNABINOIDS-GS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

REVISED LABELING FOR ADX AMPHETAMINE/METHAMPHETA.

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

REVISED LABELING FOR ADX COCAINE METABOLITE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

FDA 510(k)

FDA Class 2 ·Dental

TDX(R)/TDXFLX(TM) & ADX(R) PROPOXPHENE ASSAYS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, AW18-14550040, AW18-05060040/AA18-05060040, AW18-09060040/AA18-09060040, AW18-14560040 AW18-05070040/AA18-05070040, AW18-09070040/AA18-09070040, AW18-14570040, AW18-05080040/AA18-05080040, AW18-09080040/AA18-09080040, AW18-14580040)

FDA 510(k)

FDA Class 2 ·Cardiovascular

NIDEK STEREO DISC CAMERA(3-DX)/NIDEK STEREO FUNDUS CAMERA(3-DXF)

FDA 510(k)

FDA Class 2 ·Ophthalmic

EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SET, MODELS AB400-10, AB400-12, AB400-14

FDA 510(k)

FDA Class 2 ·Anesthesiology

SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUSION FILTER WITH ADMINISTRATION SET

FDA 510(k)

FDA Class 2 ·General Hospital

I2S DOPPLER PROBE ( 6 HOUR), I2S DOPPLER PROBE (24 HOUR), I2C DOPPLER PROBE (72 HOUR), MODELS 9090-7015, 9090-7016

FDA 510(k)

FDA Class 2 ·Cardiovascular

NATRACAREN APPLICATOR TAMPON

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

DYNAMESH-PP STANDARD, MODEL PP02NNNN, DYNAMESH-PP LIGHT, MODEL PP01NNNN

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

KFH ENERGY, MODEL: E1

FDA 510(k)

FDA Class 2 ·Neurology