X-Guide Surgical Navigation System

FDA 510(k)

FDA Class 2 ·Dental

CALMATRIX CALCIUM SULFATE BONE GRAFT BINDER

FDA 510(k)

FDA Class 2 ·Dental

SCAN WHITE 12 ML

FDA 510(k)

FDA Class 2 ·Dental

LRM PRODUCES GUIDEWIRES ON AN OEM BASIS FOR MANUFACTURERS,KIT ASSEMBLERS, AND DISTRIBUTORS.

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

H500 Multi-Sensing Oximetry System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor

FDA 510(k)

FDA Class 2 ·Cardiovascular

LAKE REGION MANUFACTURING GUIDEWIRES

FDA 510(k)

FDA Class 2 ·Cardiovascular

HYDROPHILIC COATED GUIDEWIRE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Model X-100C CO-Met™ Oximetry System

FDA 510(k)

FDA Class 2 ·Cardiovascular

LRM

FDA 510(k)

FDA Class 2 ·Cardiovascular

CLASSICSTAR NV SE AND NOVASTAR NV SE AND AAV FULL FACE MASKS

FDA 510(k)

FDA Class 2 ·Anesthesiology

Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented Mask, Veraseal 3 Full Face AAV Non-Vented

FDA 510(k)

FDA Class 2 ·Anesthesiology

Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full Face Non-Vented Mask; Veraseal 3 Full Face AAV Non-Vented Mask

FDA 510(k)

FDA Class 2 ·Anesthesiology

NANNOLIGHT INTENSE PULSED LIGHT SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LASERPEEL SOFT-MET MODIFIED ERBIUM LASER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SKINCLEAR Q-SWITCHED ND:YAG LASER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·ADVIA CENTAUR HAV TOTAL ASSAY, ADVIA CENTAUR HAV TOTAL QUALITY CONTROL MATERIALS

PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S)

FDA 510(k)

FDA Class 2 ·Physical Medicine

VUZE System

FDA 510(k)

FDA Class 2 ·Radiology

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·ADVIA CENTAUR HAV IGM READY PACK REAGENTS, ADVIA CENTAUR HAV IGM QUALITY CONTROL MATERIALS