HELIOS II Q-SWITCHED ND:YAG LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Cirq Arm System (2.0);Alignment System Spine

FDA 510(k)

FDA Class 2 ·Neurology

KILEJIAN CIRCUMCISOR

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

ICHEM 100 URINE CHEMISTRY ANALYZER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

IQ 200 URINE ANALYZER BODY FLUIDS MODULE

FDA 510(k)

FDA Class 2 ·Hematology

IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE

FDA 510(k)

FDA Class 2 ·Hematology

Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT

FDA 510(k)

FDA Class 2 ·Neurology

iChemVELOCITY Automated Urine Chemistry System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial

FDA 510(k)

FDA Class 2 ·Neurology

CONDOM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

WANDY SILICONE CONDUCTIVE RUBBER PAD

FDA 510(k)

FDA Class 2 ·Neurology

WANDY SELF-ADHESIVE NEUROSTIMULATION ELECTRODE

FDA 510(k)

FDA Class 2 ·Neurology

DIGITAL THERMOMETER; DIGITAL THERMOMETER

FDA 510(k)

FDA Class 2 ·General Hospital

Aneroid sphygmomanometer with stethoscope, QL-50, Aneroid sphygmomanometer, QL-20, Aneroid sphygmomanometer, QL-201

FDA 510(k)

FDA Class 2 ·Cardiovascular

Advanced LumFix Spinal Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

Air Compression Leg Massager (model: EMK-701)

FDA 510(k)

FDA Class 2 ·Physical Medicine

RPI SKIN OR AIR TEMPERATURE PROBE

FDA 510(k)

FDA Class 2 ·General Hospital

Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer

FDA 510(k)

FDA Class 2 ·Cardiovascular

CUPRALLOY

FDA 510(k)

FDA Class 2 ·Dental