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

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

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Cryopush Cold Compression Device

FDA 510(k)

FDA Class 2 ·Physical Medicine

Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

REFOBACIN -PALACOS G

FDA 510(k)

FDA Class 2 ·Orthopedic

PALABOND

FDA 510(k)

FDA Class 2 ·Orthopedic

Hand-held IPL device (JOVS Hair Removal Device)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Cold Compression Wrap Pro

FDA 510(k)

FDA Class 2 ·Physical Medicine

Hand-held IPL device(JOVS Graphene Hair Removal Device)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IPL Hair Removal Device, Model(s): JP1, JR3, JR8, JR9

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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