BIO-LOGIC SLEEPSCAN NETLINK

FDA 510(k)

FDA Class 2 ·Neurology

ALBUMIN REAGENT KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CEEGRAPH

FDA 510(k)

FDA Class 2 ·Neurology

TEBCO-W

FDA 510(k)

FDA Class 2 ·Cardiovascular

High Performance Liquid Chromatography For Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·BIO-RAD CYCLOSPORINE BY HPLC TEST

High Performance Liquid Chromatography For Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·BIO-RAD CYCLOSPORINE BY HPLC TEST

EMMA 1.5T MRI System

FDA 510(k)

FDA Class 2 ·Radiology

HTS EXTREMITY COIL, HTS SURFACE COIL

FDA 510(k)

FDA Class 2 ·Radiology

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·BAYER VERSANT HCV RNA 3.0 ASSAY (BDNA)

Aglaia LED Beauty Device (BP-D2309)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CLINICAL ELECTRONIC THERMOMETER

FDA 510(k)

FDA Class 2 ·General Hospital

IPL Hair Removal Device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

safety lancet

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); Lancing device (HH-X-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T, HH-XXVII-T)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type)

FDA 510(k)

FDA Class 2 ·General Hospital

Insulin Pen Needle

FDA 510(k)

FDA Class 2 ·General Hospital

Safety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3)

FDA 510(k)

FDA Class 2 ·Anesthesiology

Probe Covers (YF-001, YF-002)

FDA 510(k)

FDA Class 2 ·General Hospital