LOI SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

USTAR II System

FDA 510(k)

FDA Class 2 ·Orthopedic

Conformity stem, cemented

FDA 510(k)

FDA Class 2 ·Orthopedic

U2 Total Knee System, XPE Tibial Insert, PS PLUS

FDA 510(k)

FDA Class 2 ·Orthopedic

United U2 femoral head, 22mm delta ceramic head

FDA 510(k)

FDA Class 2 ·Orthopedic

Conformity Stem

FDA 510(k)

FDA Class 2 ·Orthopedic

ST AIA-PACK AFP ENZYME IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Immunology

OSTEOGRAF 2040 OSTEOGRAF 4060

FDA 510(k)

FDA Class 2 ·Dental

Conformity Stem Extension Line

FDA 510(k)

FDA Class 2 ·Orthopedic

PEAK PLASMABLADE 3.OS TISSUE DISSECTION DEVICE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

RAPIDPoint 500e Blood Gas System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MA25 - PORTABLE AUDIOMETER, MODIFICATION

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

DEROYAL STERILE NEONATAL BLOOD PRESSURE CUFF

FDA 510(k)

FDA Class 2 ·Cardiovascular

QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF MONODERM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

KS 5 - CLINICAL AUDIOMETER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Tibial baseplate, Tibial insert

FDA 510(k)

FDA Class 2 ·Orthopedic

ST/AR ST AND ARRHYTHMIA SOFTWARE MODEL: RELEASE K.O

FDA 510(k)

FDA Class 2 ·Cardiovascular

PEAK PULSAR II GENERATOR MODEL PS100-102

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AIA-PACK BRCA, ST AIA PACK BRCA

FDA 510(k)

FDA Class 2 ·Immunology

MAICO MA790 AUDIOMETER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat