AUTOSTAT II ANTI-PR 3 (C-ANCA)ELISA, HY*TEC ANTI-PR 3 (C-ANCA)ELISA

FDA 510(k)

FDA Class 2 ·Immunology

BRAUN Silk.expert Pro 5

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AUTOLINK BODY PLETHYSMOGRAPH

FDA 510(k)

FDA Class 2 ·Anesthesiology

MRCP+ version 2 (MRCP+ v2)

FDA 510(k)

FDA Class 2 ·Radiology

AcuPebble OX100

FDA 510(k)

FDA Class 2 ·Anesthesiology

HUMAN CAERULOPLASMIN KIT

FDA 510(k)

FDA Class 2 ·Immunology

VOXAR VC, MODEL 1.0

FDA 510(k)

FDA Class 2 ·Radiology

RANDOX EVIDENCE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

AV-S ANAESTHESIA VENTILATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20; STANDARD CALIBRATOR KIT, MODEL 3L83-01; CONTROL KIT, MODEL 3L83-10

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HABIB HEXABLATE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TRIAXIL (VP50K) KNITTED VASCULAR PROSTHESIS

FDA 510(k)

FDA Class 2 ·Cardiovascular

geko W-2

FDA 510(k)

FDA Class 2 ·Physical Medicine

CAPTIA(R) RUBELLA-G

FDA 510(k)

FDA Class 2 ·Microbiology

LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BEL-AIR VENTILATION TUBE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

CLEARBLUE EASY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Dermalux Flex MD

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NP Cement HV;NP Cement LV; NP Cement HV System; NP Cement LV System

FDA 510(k)

FDA Class 2 ·Orthopedic

Trackit T4 EEG Amplifier

FDA 510(k)

FDA Class 2 ·Neurology