DIGORA PCT

FDA 510(k)

FDA Class 2 ·Dental

TRUSIGNAL SPO2 FINGER SENSOR, TRUSIGNAL SPO2 EAR SENSOR, TRUSIGNAL SPO2 WRAP SENSOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

E-PICCO CONTINUOUS CARDIAC OUTPUT MODULE AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Cardiovascular

CONTOUR MENISCUS ARROW, MODELS 541110, 541113, AND 541116

FDA 510(k)

FDA Class 2 ·Orthopedic

INION CPS 2.5/2.8 SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

INION CPS 2.0 ORTHOGNATHIC PLATE

FDA 510(k)

FDA Class 2 ·Dental

SMARTWEDGE ACL, MODELS 430623, 430628, 430723, 430728, 430823, 430828

FDA 510(k)

FDA Class 2 ·Orthopedic

BIOSORBFX O/M 2.0/2/4 SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

CARESCAPE MONITOR B650

FDA 510(k)

FDA Class 2 ·Cardiovascular

PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX

FDA 510(k)

FDA Class 2 ·Anesthesiology

MATRYX INTERFERENCE SCREW, 239038T5,231025T5,231033T5,231038T5,231125T5,231133T5,231138T5

FDA 510(k)

FDA Class 2 ·Orthopedic

CARESCAPE MONITOR B450

FDA 510(k)

FDA Class 2 ·Cardiovascular

BIOSORBFX AND BIOSORBPDX MESH

FDA 510(k)

FDA Class 2 ·Dental

CRANEX TOME CEPH, OR CRANEX TOME

FDA 510(k)

FDA Class 2 ·Dental

CARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Anesthesiology

OSTEO ACL SCREW MODEL;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T, 239025T, 239030T, 231020T, 231025T,

FDA 510(k)

FDA Class 2 ·Orthopedic

INION HEXALON BIODEGRADABLE ACL/PCL SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

ORALIX PAN DC III CEPH OR PANORAMIC MODE ONLY

FDA 510(k)

FDA Class 2 ·Radiology

DIGORA PCT/DIGIPOD

FDA 510(k)

FDA Class 2 ·Dental