SD GlucoNFC Blood Glucose Monitoring System, SD GlucoNFC Multi Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EXPD 4343P, EXPD 3643P

FDA 510(k)

FDA Class 2 ·Radiology

EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG

FDA 510(k)

FDA Class 2 ·Radiology

Hair Up

FDA 510(k)

FDA Class 2 ·Physical Medicine

EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG

FDA 510(k)

FDA Class 2 ·Radiology

CastleLoc-S Posterior Cervical Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

Sonix Health

FDA 510(k)

FDA Class 2 ·Radiology

EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP

FDA 510(k)

FDA Class 2 ·Radiology

CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System

FDA 510(k)

FDA Class 2 ·Orthopedic

Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical Gown (PP+PE)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OLIZ LTB-1000A

FDA 510(k)

FDA Class 2 ·Physical Medicine

ARIX Ankle System

FDA 510(k)

FDA Class 2 ·Orthopedic

BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

BIO-PROBE(R) BLOOD FLOW MONITORING SYST(TX-50/50P)

FDA 510(k)

FDA Class 2 ·Cardiovascular

BIO-MODULAR SHOULDER SYSTEM WITH HYDROXYAPATITE (HA) COATED GLENOID COMPONENTS

FDA 510(k)

FDA Class 2 ·Orthopedic

NICHOLS ADVANTAGE CHEMILUMINESCENCE BIO-INTACT PARATHYROID HORMONE (1-84) IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE

FDA 510(k)

FDA Class 2 ·Dental

TRILLIUM BIO DISPOSABLE BLOOD FLOW PROBE (MODELS DP38T & FP38P)

FDA 510(k)

FDA Class 2 ·Cardiovascular

AM-BIO EXTENDED RANGE SERIES DIALYZER, MODELS WET AND DRY

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/COBAS BIO

FDA 510(k)

FDA Class 2 ·Immunology