MOBILE SOPHIE MODIFICATION

FDA 510(k)

FDA Class 2 ·Radiology

Urine/CSF Albumin, Urine/CSF Albumin Calibrator

FDA 510(k)

FDA Class 2 ·Immunology

ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch Thermometer

FDA 510(k)

FDA Class 2 ·General Hospital

Sentry IVC filter

FDA 510(k)

FDA Class 2 ·Cardiovascular

ATTUNE All-Polyethylene Tibia

FDA 510(k)

FDA Class 2 ·Orthopedic

ARTICUL/EZE Ceramic Heads

FDA 510(k)

FDA Class 2 ·Orthopedic

Pre-B Seal Lung Biopsy Plug System - 15cm Model (FG0001); Pre-B Seal Lung Biopsy Plug System - 16cm Model (FG0002); Pre-B Seal Lung Biopsy Plug System - 20cm Model (FG0003)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ALKALINE PHOSPHATASE (IFCC) PLUS, ECAL, NORTROL, ABTROL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CAPNOMAC ULTIMA(TM) ANESTHESIA MONITOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

AS/3 MEMORY MODULE, M0MEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

DELTA XTEND Reverse Shoulder System

FDA 510(k)

FDA Class 2 ·Orthopedic

Spirotrac

FDA 510(k)

FDA Class 2 ·Anesthesiology

Planmeca Romexis

FDA 510(k)

FDA Class 2 ·Radiology

Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

WSP CODE 4315 PADTEST

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

pRESET Thrombectomy Device

FDA 510(k)

FDA Class 2 ·Neurology

OLYMPUS IGM REAGENT

FDA 510(k)

FDA Class 2 ·Immunology

VitaMESH Macroporous PP Surgical Mesh

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ATTUNE Revision Knee System

FDA 510(k)

FDA Class 2 ·Orthopedic

EMBOGUARD Balloon Guide Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular